Wound Masterclass - December 2023

Volume 2: Issue 6 - December 2023

woundmasterclass.com Open Access | Peer Reviewed | International | Quarterly ISSN 2753-6963

Searching for the Resilient Option in Healing

Should Electrical Stimulation be Considered in Synergy with Compression Therapy?

A Versatile Framework to Implement Wound Care Competency Programs How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds Optimizing Non-Healing Venous Leg Ulcers and Diabetic Foot Ulcers Role of TLC-NOSF Dressings to Optimize Healing in Diabetic Foot Ulcers

Masterclass GUIDES

Allograft Placental Matrix

M.O.I.S.T. Wound Educational Model

Allograft Dermal Matrix

Wound Cleaning Products Official Journal of the Association for the Advancement of Wound Care®

Editorial Board

United Kingdom & Europe Dr Negin Shamsian

Prof Dimitri Beeckman

Dr Przemysław Lipiński

Prof Dr C. Can Cedidi

Dr Guido Ciprandi

Consultant Plastic & Reconstructive Surgeon (Locum)

Professor of Nursing Science, Ghent University (Belgium) and Vice-Head of the School of Health Sciences, Örebro University (Sweden)

Wound Surgeon, National Representative of Poland in D-Foot International

Clinic Director for Plastic, Reconstructive & Aesthetic Surgery

Professor of Wound Care at the Universities of Rome, Pavia, Turin, Trieste and Pisa

Łódź, Poland

Bremen, Germany

Specialist in thoracic surgery and pediatric surgery

Chief Editor of Wound Masterclass

Ghent, Belgium

London, United Kingdom

Rome, Italy

Dr Paul Chadwick

Mr Harm Jaap Smit

Ms Lian Stoeldraaijers

Prof Declan Patton

National Clinical Director, Royal College of Podiatry

Wound Biologist, Erasmus MC Academy Rotterdam

President, Dutch Association of Diabetes Podiatrists

Manchester, United Kingdom

Rotterdam, Netherlands

Valkenswaard, Netherlands

Director of Nursing and Midwifery Research and Deputy Director of SWaT Research Center, RCSI University of Medicine and Health Sciences Dublin, Ireland

Prof Jan Kottner

Prof Dr Luca Dalla Paola

Dr Sebastian Probst

Prof Dr Marco Romanelli

Professor of Nursing Science, Charité - Berlin University of Medicine

Specialist in Endocrinology, Metabolic Diseases and Diabetology

EWMA President

Berlin, Germany

Expert in medical and surgical treatment of Diabetic Foot

Full Professor and Chairman, Division of Dermatology, Department of Clinical and Experimental Medicine, University of Pisa

Ferrara, Italy

Professor of Tissue Viability and Wound Care at the School of Health Sciences, University of Applied Sciences and Arts Western Switzerland, Geneva

Pisa, Italy

Genf, Switzerland

North America Mr Frank Aviles

Ms Kara Couch

Dr Kenneth Burhop

Mr Tobe Madu

Wound Care Clinical Coordinator, Natchitoches Regional Medical Center

President-Elect, Association for the Advancement of Wound Care

Life Sciences Advisor and Consultant

Data Scientist, Net Health

Associate Research Professor of Surgery, School of Medicine and Health Studies George Washington University

Natchitoches LA, United States

San Diego CA, United States

Atlanta GA, United States

Director, Wound Care Services, The George Washington University Hospital

Arlington VA, United States

Dr Windy Cole

Dr M. Mark Melin

Dr Leo Nherera

Dr Brandon Bosque

Director of Wound Care Research, Kent State University of Podiatric Medicine

Medical Director of the M Health Wound Healing Institute

Director, Global Head of Health Economics & Outcomes Research

Foot and Ankle Surgeon

National Director of Clinical Safety, Quality and Education, Woundtech

Adjunct Associate Professor, University of Minnesota Surgical Department

Fort Worth TX, United States

Streetsboro OH, United States

Philadelphia PA, United States

Mineapolis MN, United States

Dr Mitch Sanders

Prof David Armstrong

Dr Aliza Lee

Dr Alton R. Johnson

CSO and EVP Alira Health.

CEO of WoundForce Inc. and Firefly Innovations LLC.

Professor of Surgery and Director, Southwestern Academic Limb Salvage Alliance (SALSA), Keck School of Medicine of USC

Clinical Research Investigator, Department of Veterans Affairs

Podiatric Surgeon

Salem VA, United States

Ann Arbor MI, United States

Boston MA, United States

Los Angeles CA, United States

Dr Jonathan Johnson

Dr David Alper

Dr Ruth Bryant

Surgical Director, Comprehensive Wound Care Services

Trustee - Board of Trustees, American Podiatric Medical Association

Nurse Scientist and WOC nurse, Abbott Northwestern Hospital

Board Member - American Diabetes Association (New England)

Washington DC, United States

Surgical staff (Emeritas) - Mount Auburn Hospital Cambridge, MA, United States

Minneapolis MN, United States

Boston MA, United States

East Asia

Australia

South & Central America

Dr Joon Pio Hong

Dr Ross D Farhadieh

Professor of Plastic and Reconstructive Surgery at the University of Ulsan College of Medicine and Asan Medical Center

Cosmetic Plastic & Reconstructive Surgeon Sydney, Australia

Prof Dr Harikrishna K. R. Nair President Elect, WUWHS - World Union of Wound Healing Societies

Ms Terry Swanson

Dr Eduardo Camacho

Vice Chair, International Wound Infection Institute

Plastic and Reconstructive Surgeon

Victoria, Australia

Mexico City, Mexico

President, Asia Pacific Association of Diabetic Limb Problems Kuala Lumpur, Malaysia

Dr Honda Hsu Plastic Surgeon and Associate Professor, Tzu Chi General Hospital Hualien, Taiwan

Middle East Sr Trish Idensohn

Prof Amit Gefen

Wound Nurse Specialist, Consultant and Educator

Professor of Biomedical Engineering, Tel Aviv University

Durban, South Africa

Head and Neck Surgeon, Associate Professor Instituto Universitario Hospital Italiano Buenos Aires, Argentina

Seoul, South Korea

Africa

Dr Luis Alejandro Boccalatte

Tel Aviv, Israel

Wound Care Physician

December 2023

Chief Editor Miss Negin Shamsian Commercial Director Mr Alec Wright Contact Editor

Searching for the Resilient Option in Healing | Dr Negin Shamsian

3

Fluid Shifts in Space Flight Analogues and Terrestrial Wound Clinic Applications | Dr M. Mark Melin, Dr Heather Barnhart, Mr Frank Aviles, Ms Sabrina Ginsburg

4

Optimizing Non-Healing Venous Leg Ulcers and Diabetic Foot Ulcers: Standard of Care vs Amniotic Membrane | Dr Alton R. Johnson, Mr Shenlone Wu, Ms Briana Lay

12

Evolution of Dressing Change Frequency for Patients with Wounds | Dr Negin Shamsian

22 - 23

Jump-starting Healing in Venous Leg Ulcers: Should Electrical Stimulation be Considered in Synergy with Compression Therapy? | Dr Keith Gordon Harding

24 - 27

Role of TLC-NOSF Dressings to Optimize Healing in Diabetic Foot Ulcers | Ms Michelle Goodeve, Ms Laura Saunders

32 - 36

A Versatile Framework to Quickly Implement Wound Care-Specific, RoleBased Competency Programs | Dr Elaine H. Song, Ms Catherine T. Milne, Ms Tiffany Hamm, Ms Nataliya Lebedinskaya, Ms Janis Prado, Mr Jeff Mize

38 - 39

How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide | Mr John Timmons, Dr Matthew Malone, Prof Dr Joachim Dissemond

40 - 52

Global Innovation in Wound Care Summit Series: Biofilm Masterclass

58 - 61

Global Innovation in Wound Care Summit Series: What Do I Need to Know About Skin Substitutes?

62 - 67

MasterSeries 60 Minutes Interactive: Clinical Challenges and Solutions in Palliative Wound Management

70 - 80

Biodegradable Matrix Offers Limb-Saving Option for Chronic Ischaemia | Ms Victoria Bristow

82 - 84

What Is the Role of Platelet-Derived Biologics? | Prof Anand Pillai, Dr Vish Kumar

85 - 87

MasterSeries 60 Minutes Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation

88 - 102

editor@woundmasterclass.com

Commercial Inquiries commercial@woundmasterclass.com

Article Submissions submissions@woundmasterclass.com

Published by Clarus Communications Ltd., Oxford, United Kingdom No part of this issue is to be copied or reproduced without permission of the publisher © Clarus Communications Ltd.

This publication is intended for online distribution and this issue is not suitable for print in this form To inquire about obtaining a printable version of this issue or any article therein, please contact the editor

Cover image:

Masterclass GUIDES Licenced from Adobe Stock Credit: psynovec

Allograft Placental Matrix

8 - 11

Allograft Dermal Matrix

18- 21

Wound Cleaning Products

28 - 31

M.O.I.S.T. Wound Educational Model

54 - 57

Time to heal diabetic foot ulcers 50% 1 shorter than with standard of care – with Granulox®

Learn more about what Granulox® can do for your patients: www.molnlycke.com/granulox References: 1. Hunt, SD., Elg, F. Clinical effectiveness of hemoglobin spray (Granulox®) as adjunctive therapy in the treatment of chronic diabetic foot ulcers. November 2016.

Mölnlycke Health Care AB, P.O. Box 13080, Gamlestadsvägen 3 C, SE-402 52 Göteborg, Sweden. Phone + 46 31 722 30 00. The Mölnlycke and Granulox trademarks, names and logos are registered globally to one or more of the Mölnlycke Health Care Group of Companies. © 2021 Mölnlycke Health Care AB. All rights reserved. HQIM002731

Searching for the Resilient Option in Healing December 2023 As wound care clinicians, we constantly face challenges in healing our patients' wounds. Chronic wounds that fail to progress through the normal stages of healing require us to look beyond the standard limitations in our treatment options. However, focusing our efforts on searching for the resilient factor in wound healing may provide a better path forward.

Rather than viewing wounds that are stalled in the inflammatory stage as failures, shifting our perspective to see them as adaptations may enable us to tackle them from a different perspective. The wound is stuck attempting to protect itself from further harm. By identifying the barriers preventing the wound from healing and providing targeted interventions to reduce inflammation and infection, we can support the wound’s innate resilience mechanisms. Removing these impediments allows the body’s robust self-healing abilities to bring the wound back onto a healing trajectory.

Viewing wound healing through a lens of resilience enables us to collaborate with our patients’ physiology rather than fighting against it. This approach directs us to search for interventions that align with the wound’s natural resilience factors. In doing so, we may find more effective treatments that do not override but rather unlock the body's intrinsic capacity to heal.

A

s we approach the end of 2023, the Wound Masterclass team wishes to express our deep gratitude to all those who contributed to making this year an impactful one in wound care research and education.

We sincerely thank our dedicated readers, subscribers, authors, peer reviewers, partners, and collaborators worldwide. Together, through sharing free online access and knowledge in the Wound Masterclass Journal, Innovation Summit Series, Interactive MasterSeries, and Podcast, we have made great progress in improving patient outcomes related to wound prevention, assessment, treatment, and healing.

We have had record global engagement and we are the first fully sustainable free global wound care journal.

This year, we published over 100 insightful articles, studies, commentaries, and best practices that have the potential to meaningfully advance wound care and quality of life for millions. We have also seen record levels of global engagement and readership. We are honored to play a role in disseminating vital clinical work to wound care professionals across borders.

As the calendar year draws to a close, it is worthwhile to pause and reflect on the advances made in wound care in 2023. Despite the ongoing challenges of the pandemic, this year saw several impactful developments that give hope for continued progress in promoting healing and improving patient quality of life.

Several articles in this winter issue of Wound Care Journal highlight recent successes. The use of biodegradable temporizing matrices,

© Copyright. Wound Masterclass. 2023

possibilities for treating chronic limb ischemia and temporizing tissue loss. Research by Alton Johnson et al. on the comparative effectiveness of amniotic membranes represents important work toward optimizing standard protocols for venous leg ulcers and diabetic foot ulcers. And work by Michelle Goodeve et al. demonstrates the potential for TLC-NOSF dressings to enhance diabetic ulcer healing.

While more work remains, the progress made this year reinforces the power of partnership and discovery to transform patient lives. As we venture into a new year, I am energized by the innovations featured at this year's Wound Masterclass Global Innovation in Wound Care Summit Series, Wound Masterclass MasterSeries 60 Minutes Interactive, The Wound Masterclass Podcast, and in the pages of this journal issue. Our community's dedication gives me optimism that each year will bring us closer to definitive solutions for even the most complex wounds. I look forward to seeing what we can accomplish together in 2024.

Ultimately, this progress would not be possible without all of you. We look forward to continuing this collaborative mission in the years ahead as we learn, grow, and serve patients, clinicians and researchers worldwide.

We wish you happy holidays and a wonderful start to 2024! With gratitude from the entire Wound Masterclass team.

Dr Negin Shamsian Consultant Plastic & Reconstructive Surgeon (Locum) Chief Editor of Wound Masterclass London, United Kingdom

Wound Masterclass - Vol 2 - December 2023

3

Fluid Shifts in Space Flight Analogues and Terrestrial Wound Clinic Applications Editorial Summary In space, astronauts experience fluid shifts from their legs to their upper body, causing symptoms like head fullness and vision changes known as Spaceflight Associated Neuroocular Syndrome (SANS). NASA researchers are studying SANS using analog tests that simulate space conditions. They use noninvasive imaging techniques to monitor fluid shifts and develop countermeasures. These techniques could also be useful in improving wound care by diagnosing lymphatic dysfunction and edema. NASA's research in nutrition and other areas can benefit healthcare. By adopting advanced technologies, similar to the James Webb telescope, wound clinics can achieve better outcomes.

Introduction

S Dr M. Mark Melin

Dr Heather Barnhart

Medical Director of the M Health Wound Healing Institute

Professor, Dept of Physical Therapy, Nova Southeastern University

Adjunct Associate Professor, University of Minnesota Surgical Department Mineapolis MN, United States

Fort Lauderdale FL, United States

pace travel poses unique challenges for astronauts, including significant fluid shifts from the legs to the upper body, leading to symptoms such as head ‘fullness’ and altered vision. This condition, known as Spaceflight Associated Neuroocular Syndrome (SANS), is a priority area of research for NASA as they plan future missions to the moon and Mars. Earthbased studies use space flight analogue testing to simulate these fluid shifts, but real-time imaging of fluid shifts in a head-down position has been lacking. Recent advancements in noninvasive imaging techniques have shown promise in monitoring fluid shifts and understanding SANS. Additionally, these imaging technologies hold potential for improving diagnostics and treatments in wound care, particularly for conditions like venous leg ulcerations and lymphedema. By applying lessons learned from space research, we can explore innovative approaches and enhance patient outcomes in wound care.

Fluid Shifts in Low Earth Orbit (LEO) Entering Low Earth Orbit (LEO) induces a significant fluid shift in astronauts, where approximately 2 litres of fluid move from the legs to the upper torso, neck, and head. This fluid shift occurs within the first 24 hours in LEO and is followed by human physiology adaptation over the following 7 days. However, the resolution of fluid shifts varies, and complete improvement is not always achieved.

Mr Frank Aviles

Ms Sabrina Ginsburg

Wound Care Clinical Coordinator, Natchitoches Regional Medical Center

University of Miami Miller School of Medicine HPSP Student

Natchitoches LA, United States

Lake Worth, Florida, United States

4

Wound Masterclass - Vol 2 - December 2023

Symptoms of Spaceflight Associated Neuroocular Syndrome (SANS) Astronauts in space experience various symptoms associated with Spaceflight Associated Neuroocular Syndrome (SANS).

These symptoms include a sense of ‘fullness’ in the head, stuffy nose, and altered taste sensation. Furthermore, approximately 40 - 70% of the crew develops varying symptoms of SANS. The syndrome leads to ocular, retinal, and vision changes, retinal nerve thickening, and alterations in fluid distribution within the

© Copyright. Wound Masterclass. 2023

Fluid Shifts in Space Flight Analogues and Terrestrial Wound Clinic Applications

“By providing valuable insights into fluid distribution associated with different body positions (head down vs. supine vs. sitting up), noninvasive imaging techniques can contribute to improved diagnosis, treatment, and prevention of SANS."

brain, including cerebrospinal fluid shifts.

Recent Head Down Tilt Analogue Study

Causes and Priorities for Investigating SANS

Our team recently conducted a head-down tilt spaceflight analogue study to examine fluid shifts in volunteers. In this study, we utilized long wave infrared thermography, Near-Infrared Spectroscopy (NIRS), and a subcutaneous edema monitor. These imaging techniques are current standard options in wound clinics and readily available for point-of-care diagnostics.

The cause of SANS is hypothesized to be multifactorial, involving factors such as genetics, altered micronutrient pathways, elevated CO2 exposure on the International Space Station, increased radiation exposure, and alterations in androgen hormones. Currently, there are no fully effective countermeasures for SANS. As astronauts plan future ventures to the moon's surface and long-duration spaceflights to Mars, the investigation of SANS and the development of reliable treatments have become among the highest priorities for NASA researchers.

Space Flight Analogue Inducing Fluid Shifts

Testing

and

To understand the causes and effects of fluid shifts in space, researchers perform Earth-based research using volunteers involved in space flight analogue testing. One type of analogue testing involves placing volunteers on a bed with a 6-degree head-down tilt to simulate fluid shifts from the legs to the torso, head, and neck, mimicking certain aspects of being in LEO. It is important to note that this analogue testing does not replicate ‘true weightlessness' experienced by astronauts in spaceflight. Nonetheless, it is a validated model capable of inducing symptoms of SANS.

Potential of Noninvasive Imaging for Fluid Shift Monitoring and Countermeasure Development The utilization of validated noninvasive imaging devices holds promise in monitoring fluid shift patterns in real-time. These devices can assist in further understanding the dynamics of fluid shifts and contribute to the development of countermeasures for SANS. By providing valuable insights into fluid distribution associated with different body positions (head down vs. supine vs. sitting up), noninvasive imaging techniques can contribute to improved diagnosis, treatment, and prevention of SANS. Figure 1: Body lymphatics.

Limitations of Current Analogue Testing Methods Although analogue testing can induce symptoms of SANS, there is a limitation when it comes to real-time noninvasive imaging of the fluid shifts accompanying the head-down position. To date, such imaging has not been completed, presenting a gap in understanding the dynamics of fluid shifts during simulated space conditions.

© Copyright. Wound Masterclass. 2023

Wound Masterclass - Vol 2 - December 2023

5

Fluid Shifts in Space Flight Analogues and Terrestrial Wound Clinic Applications

“Embracing noninvasive imaging technologies represents a paradigm shift in wound care, providing clinicians with valuable insights into the comprehensive pathophysiology of wounds and enabling targeted interventions for optimal patient care.”

Significance of Gravity-Induced Fluid Shifts in Wound Care In the field of wound care, we encounter patients daily who experience significant fluid shifts influenced by the constant pull of gravity.

Conditions such as venous leg ulcerations (VLU), lymphedema associated with VLUs, lymphatic dysfunction in diabetics with foot ulcerations, and other lower extremity chronic wound pathologies, are affected by these fluid shifts. Recognizing the impact of gravity, we emphasize the importance of consistent compression and leg elevation management to improve leg wound outcomes.

Improving Diagnostics for Lymphatic Dysfunction and Edema The potential of noninvasive imaging techniques such as longwave infrared thermography, NIRS, and subcutaneous edema monitors can be harnessed to enhance diagnostics in cases of lymphatic dysfunction and edema associated with leg ulcerations. Lymphedema and resulting diffuse edema significantly compromise lower extremity wound healing and increase wound recidivism rates. However, clinical recognition of lymphedema remains poorly acknowledged in most wound and vein centers, which compromises patient outcomes. By utilizing the entire spectrum of ‘light' beyond human Figure 2: NASA space station.

visible wavelengths, these noninvasive imaging techniques offer a promising approach to improve the recognition and understanding of the underlying pathophysiology, supporting advanced research and enhanced treatments in common wound clinic pathologies.

The Role of Noninvasive Imaging in Enhancing Wound Care Outcomes Noninvasive imaging devices hold great potential as point-of-care tools in wound clinics.

By allowing for the recognition and early treatment of lymphatic dysfunction associated with living on Earth in a ‘1G' environment, as well as monitoring fluid shifts to the lowest points of the body, these devices can significantly improve wound care outcomes.

Embracing noninvasive imaging technologies represents a paradigm shift in wound care, providing clinicians with valuable insights into the comprehensive pathophysiology of wounds and enabling targeted interventions for optimal patient care.

Healthcare Spinoffs and NASA Research NASA's extensive research efforts have resulted in numerous ‘healthcare spinoffs' that have the potential to benefit the patients we serve. Areas such as nutrition and wound care management, often overlooked, have received considerable attention from NASA. These research endeavors provide valuable knowledge and insights that can be applied to improve healthcare outcomes.

Exploration of Wound Care Management in NASA Research Wound care management is one area where NASA research can contribute significantly.

For those interested in delving deeper into the subject, NASA's publication on human adaptation to spaceflight and nutrition in 2021 offers a wealth of knowledge, showcasing the agency's commitment to advancing our

6

Wound Masterclass - Vol 2 - December 2023

Fluid Shifts in Space Flight Analogues and Terrestrial Wound Clinic Applications

“By providing valuable insights into fluid distribution associated with different body positions (head down vs. supine vs. sitting up), noninvasive imaging techniques can contribute to improved diagnosis, treatment, and prevention of SANS."

understanding of spaceflight human adaptive physiology and its implications for healthcare.

Embracing Technological Advances for Enhanced Patient Outcomes Similar to the paradigm shift brought about by the James Webb telescope in our understanding of celestial bodies, incorporating advanced technologies into wound clinics has the

potential to revolutionize treatments and outcomes for the patients we care for. By adopting and integrating ‘James Webb telescope' technology (referring metaphorically to noninvasive imaging devices) into wound clinics, we stand at the threshold of remarkable advancements in wound care. As we embrace these new possibilities, we position ourselves at the forefront of wound care advances, ready to propel patient outcomes to new heights.

References 1. Lee AG, Mader TH, Gibson CR, Brunstetter TJ, Tarver WJ, Spaceflight-associated neuroocular syndrome. JAMA Ophthalmol. 2017;135(5):534-540.

2. Marshall-Bowman K, Barr YR, Herold DM, Barr AM, Schneider JS, Cardenas F. The impact of long-duration spaceflight on neurocognitive functioning: NASA Evidence Report. Aviat Space Environ Med. 2021;92(6):621-628.

3. Alperin N, Bagci AM, Lee SH, Lam BL. Reduced orbital CSF volume in Spaceflight Associated Neuro-Ocular Syndrome (SANS). J Neuroimaging. 2020;30(1):21-27.

4. Zwart SR, Gibson CR, Mader TH, et al. Vision changes after spaceflight are related to alterations in folate- and vitamin B-12-dependent one-carbon metabolism. J Nutr.

2012;142(3):427-431 5. Hargens AR, Bhattacharya R, Schneider SM. Space physiology VI: exercise, artificial gravity, and countermeasure development for prolonged space flight. Eur J Appl Physiol.

2013;113(8):2183-2192 6. Zwart SR, Laurie SS, Chen JJ, et al. Lower body negative pressure treadmill exercise as a countermeasure for bed rest-induced bone loss in female identical twins. Bone.

2020;130:115087.

7. Stenger MB, Platts SH, Ribeiro LC, et al. Resistance exercise training as a countermeasure to disuse-induced bone loss. J Appl Physiol (1985). 2009;107(4):105-113.

© Copyright. Wound Masterclass. 2023

8. Blaber AP, Goswami N, Bondar RL, Kassam MS. Impairment of cerebral blood flow regulation in astronauts with orthostatic intolerance after flight. Stroke. 2011;42(7):1844-1850.

9. Clément G, Ngo-Anh JT. Space physiology and operational space medicine. Annu Rev Physiol. 2011;73:293-320.

10. Watenpaugh DE, Ballard RE, Schneider SM, Lee SM. Human cardiovascular responses to six months of head-down tilt. Aviat Space Environ Med. 2000;71(2):150-157.

11. Yoonessi A, Patwardhan AG, Porter RW, Rekant MS. Magnetic resonance imaging: a threedimensional study of normal talocalcaneal alignment. Foot Ankle Int. 2003;24(10):769-773.

12. Balldin UI, Scott SC, Zajtchuk JT, Hatch TF. Evaluation of venous gas emboli in swine after decompression: Doppler detection and relationship to symptom development. Aviat Space Environ Med. 1985;56(3):241-247.

13. Witte CL, Holdsworth DW, Drangova M. Quantification of the peripheral venous system in humans using high-resolution MR venography. J Appl Physiol (1985). 2005;98(5):2125-2131.

14. Kim SH, Oh TS, Lew DH, Lee HS, Rhie JW. Monitoring of the survival of perforator flaps using indocyanine green angiography: a preliminary study. Arch Plast Surg. 2013;40(5):452-457.

15. Ganchev RN, Novoselov NP, Savel'ev AS. Use of modern diagnostic technologies in examining patients with lower limb lymphedema. Vestn Khir Im I I Grek. 2015;174(2):75-79.

Wound Masterclass - Vol 2 - December 2023

7

Masterclass GUIDES Introduction

Allograft Placenta Matrix: AmnioBand® Keywords

This Masterclass guide is a concise overview aimed at exploring the use of AmnioBand® and how to incorporate this into your practice.

AmnioBand® is a minimally processed human allograft which retains the structural properties of the extracellular matrix. It contains collagen matrix, growth factors, and endogenous neonatal cells that promote healing which can be utilized for burns, venous ulcers, diabetic foot ulcers, and other complex wounds.

What Is AmnioBand ?

■ Allograft ■ Re-epithelialization ■ Diabetic foot ulcerations ■ Ulcers

■ Wound healing ■ AmnioBand ■ Placenta matrix ■ Membrane ®

Figure 1: AmnioBand® Application Sizes.

®

■ AmnioBand Membrane is intended to be used as a protective ®

covering for internal and external tissue defects including acute, chronic and surgically created wounds1,2

■ This bi-layer amnion and chorion membrane helps in native tissue restoration and remodeling, providing optimal coverage in a wide variety of sizes for all types of acute and chronic wounds

■ Because it’s flexible, it conforms to the wound site with ease and aseptic processing preserves the natural structure2

■ Maintains inherent growth factors, matrix proteins, and endogenous viable cells shown to support host tissue

Figure 2: AmnioBand® Allograft Placental Matrix.

AmnioBand® Preparation Guide ■ AmnioBand Membrane is packaged in a sterilized foil pouch that ®

is designed to be passed directly into the sterile field. Use standard aseptic/sterile technique to open package

1.

Prepare wound area using standard methods to ensure wound is free of debris and necrotic tissue

2.

Peel open chevron seal of outer Tyvek pouch and pass inner foil pouch to sterile field

3.

Peel open chevron seal of inner pouch and remove tissue from inner pouch using sterile gloves/forceps

4.

In a dry state, use sterile dry scissors to trim AmnioBand® Membrane to fit dimensions of application site. It is recommended no more than 0.5mm-2mm overlap over the wound margin

5.

Apply AmnioBand® Membrane directly to patient site. If needed, membrane may be hydrated with sterile saline

6.

Anchor AmnioBand® Membrane with tissue adhesives or by suturing the sheet, ensuring first that graft overlaps adjacent intact skin

7.

Use appropriate, non-adherent, primary dressing and secondary dressing to maintain a moist wound environment and the placement of the tissue

■ NOTE: Ensure wound site is free of debris and necrotic tissue.

Debride if necessary prior to graft placement

■ NOTE: Once foil pouch is opened, tissue should be used promptly

20

Wound Masterclass - Vol 2 - December 2023

Allograft Placenta Matrix: AmnioBand®

Masterclass GUIDES

What Types of Wounds Are Suitable?

What Types of Wounds Are Not Suitable?

■ Diabetic foot ulcers ■ Venous leg ulcers ■ Pressure ulcers ■ Homologous uses

■ The presence of severe vascular compromise ■ Active or latent infection ■ Uncontrolled infection

Warnings and Precautions ■ Do not sterilize ■ Prescription use only ■ No known sensitizing agents are present in this tissue. NOTE: No

Figure 3: AmnioBand®

antibiotics were used in the processing of this tissue

■ Do not use if container seal is not intact or damaged, if container label or identifying barcode is severely damaged, not legible or missing or if expiration date shown on container label has passed

■ AmnioBand Membrane should be stored at ambient temperature ■ Do not refrigerate or freeze ■ It is the responsibility of the transplant facility or clinician to ®

maintain the tissue intended for transplantation in the appropriate recommended storage conditions prior to transplant

■ Extensive medical screening procedures have been used in the

selection of all tissue donors for the Musculoskeletal Transplant Foundation (MTF) (please see MTF’s Donor Screening and Testing document)

■ Transmission of infectious diseases such as HIV or hepatitis, as well

as a theoretical risk of the Creutzfeldt-Jakob (CJD) agent, may occur in spite of careful donor selection and serological testing

Wound Masterclass - Vol 2 - December 2023

21

Masterclass GUIDES

Allograft Placenta Matrix: AmnioBand®

What Is the Evidence?

Recent clinical results of allografts derived from amnion and chorion placental layers encourage further investigation of the mechanisms underlying clinical efficacy of these products for treatment of wounds. In recent years, there has been a significant increase in the use of amniotic membrane to treat difficult, stubborn lesions such chronic venous leg ulcers.4 The site investigator classified index wounds as healed if complete (100%) epithelialization took place without drainage or the need for treatment.5

Efficacy ■ When applied either weekly or biweekly

to patients with chronic venous leg ulcers, AmnioBand achieved full wound closure in 75 percent of patients over the 12-week period6

Pain ■ In general, chronic wounds exhibit several

■ The study also found the AmnioBand groups

had a significantly higher median percentage wound area reduction of 100% vs 75% wound area reduction in the standard of care alone group at the twelve-week timepoint6

22

Wound Masterclass - Vol 2 - December 2023

pathological characteristics not present, or present only to a lesser degree, in healing wounds or in normal skin including excessive matrix degradation through unbalanced MMP/TIMP ratios, unresolved inflammatory responses, persistent wound infection (which can also further prolong the duration of the inflammatory response), and desensitization of wound edges to reparative stimuli via dysfunctional epidermal cell behavior, among many others7,8

Debridement ■ Lowest demonstrated graft cost to closure evidenced by published peerreviewed prospective Level 1 publications

Allograft Placenta Matrix: AmnioBand®

Masterclass GUIDES

Key Points ■ Aseptic processing preserves tissue’s natural structure ■ Ready, right out of the package ■ Can be used in the hydrated or dehydrated state ■ Shelf life of three years at ambient temperature ■ Flexible ■ Conforms to anatomy and maintains surface contact

“Given its modest cost and ability to heal recalcitrant DFUs, the dHACA graft may have clinical applications in patients with even more complex wounds that are deep to tendon and bone.” DiDomenico, et al., 2018 5 “dHACA plus SOC treatment for nonhealing DFUs over 6 and 12 weeks has been shown to heal DFUs significantly faster than SOC with minimal graft wastage.” DiDomenico, et al., 2018 5

References 1. AmnioBand® Viable Membrane, Allograft Placental Matrix. (n.d.). AmnioBand® Viable Membrane, Allograft Placental Matrix.

2. AmnioBand® Membrane. (2015, December 4). WoundSource.

3. ElHeneidy H, Omran E, Halwagy A, Al-Inany H, Al-Ansary M, Gad A. Amniotic membrane can be a valid source for wound healing. Int J Womens Health. 2016 Jun 27;8:22531 4. Kogan S, Sood A, Granick MS. Amniotic membrane adjuncts and clinical applications in wound healing: A review of the literature. Wounds 2018;30:168–173.

5. DiDomenico LA, Orgill DP, Galiano RD, Serena TE, Carter MJ, Kaufman JP, Young NJ, Zelen CM. Aseptically Processed Placental Membrane Improves Healing of Diabetic Foot Ulcerations: Prospective, Randomized Clinical Trial. Plast Reconstr Surg Glob Open. 2016 Oct 12;4(10):e1095. doi: 10.1097/GOX.0000000000001095. PMID: 27826487; PMCID: PMC5096542.

6. New Study Finds AmnioBand® Membrane Effectively Heals Venous Leg Ulcers in Less Time. (2022, November 29). New Study Finds AmnioBand&Reg; Membrane Effectively Heals Venous Leg Ulcers in Less Time | Business Wire.

7. P. Martin, R. Nunan, Cellular and molecular mechanisms of repair in acute and chronic wound healing, Br. J. Dermatol. 173 (2) (2015) 370–378.

8. J.N. Brantley, T.D. Verla, Use of placental membranes for the treatment of chronic diabetic foot ulcers, Adv. Wound Care 4 (9) (2015) 545–559.

Useful Links

Use your device to scan this QR code for more information about AmnioBand®

Visit the MTF Biologics website

How to Cite this Article Masterclass Guide: Allograft Placenta Matrix: AmnioBand®. Wound Masterclass. Volume 2. No 7. December 2023

Sponsored by MTF Biologics. All production resources provided by MTF Biologics.

Wound Masterclass - Vol 2 - December 2023

23

Optimizing Non-Healing Venous Leg Ulcers and Diabetic Foot Ulcers: Standard of Care vs Amniotic Membrane Editorial Summary This study is a retrospective review of comparative wound size changes when using standard of care (SOC) versus amniotic membrane (AM). The patient group had either non-healing venous leg ulcers (VLU) or diabetic foot ulcers (DFU). The inclusion criteria for this study was patients who had experienced minimal wound size change after 5-weeks of SOC, in effect considering amniotic membrane as an alternative treatment for a further 5-weeks of treatment. The wound sizes were measured at three points: 1) the initial treatment phase with SOC, 2) the end of SOC (after 5 weeks) or the beginning of AM treatment and 3) 5 weeks after the amniotic membrane treatment, as the comparative modality.

Introduction

S

tandard of Care (SOC) for non-healing wounds typically comprises of debridement of necrotic and infected tissue, establishing adequate circulation, maintaining a moist periwound environment, infection control, and offloading or compression dependent on the etiology of the wound itself.1 Standard of Care can vary due to clinician judgement and wound type. It is acknowledged as a time consuming and potentially less efficient method for treating chronic wounds which is why there has been a recent push for evidence based-innovation.

One of which is Amniotic Membrane (AM) or amnion. AM has been evidenced in consideration of reconstruction due to the pluripotent properties of AM cells.2 AM has an avascular structure comprising of three layers containing collagen, extracellular matrix, and biologically active cells (mostly stem cells). Collagen is a naturally occurring matrix polymer and provides a structure to the amniotic membrane. Regulated by growth factors such as cytokines, chemokines, and other endogenous cells that are contained in the matrix of AM, this allows for epithelialization.

Dr Alton R. Johnson University of Michigan Ann Arbor MI, United States

The largest organ of the human body, skin is fundamentally the first line of defense, so when we consider the implication of chronic ulcers there is a severe infection risk with any breach of the epithelial surfaces leaving the patient vulnerable to cross contamination of bacteria and a possible site of sepsis. When this protective surface is compromised, it can lead to increased morbidity and mortality and increase the challenge of wound care.

Mr Shenlone Wu

Ms Briana Lay

University of Nevada, Las Vegas (UNLV)

University of California, Los Angeles (UCLA)

Las Vegas NV, United States

Los Angeles CA, United States

The classification of what constitutes a ‘chronic wound' is a wound persisting for more than 6-weeks, where no sign of healing has been highlighted.3 When a patient presents with a chronic wound, a clinician can identify this as they exhibit an stalled healing process that is different to an acute wound. This usually presents in the form of inflammation, wound infection, hypoxia, poor nutrition or possibly a biofilm element.

Some of the factors that cause chronic wounds to persist include diabetes, weakened immune systems, and poor blood circulation.

12

Wound Masterclass - Vol 2 - December 2023

© Copyright. Wound Masterclass. 2023

Optimizing Non-Healing Venous Leg Ulcers and Diabetic Foot Ulcers: Standard of Care vs Amniotic Membrane

“One study found that the combination method of SOC and AM resulted in an improved healing rate for patients with diabetic foot ulcers, in comparison to the use of SOC alone. However, not all chronic wounds result in a complete healing when using amniotic membrane as a method of treatment despite the advantages.”

When we consider non-healing chronic wounds, this is likely due to complications such as infections like cellulitis and/or osteomyelitis.4 In the context of current standard of care for chronic wounds this involves a number of steps, including; wound swabs, debridement of the wound to remove necrotic tissue, and dressing the wound and maintaining a moist environment to encourage healthy tissue re-epithelialization. There has also been advancements and developing technologies in wound care strategies that are now being implemented across the world.

During the late 20th Century physicians began to experiment with AM as a form of wound treatment which provided various benefits like anti-inflammatory responses, bacteriostatic response (prevention of reproduction of microorganisms, not necessarily killing the bacteria), and scarprevention properties. These advantages of AM are generated from the cytokines that promote cell proliferation and differentiation.5 The Food and Drug Administration (FDA) has approved the use of AM for venous leg ulcers and diabetic foot ulcers. One main function of the AM is to provide tissue regeneration where there is a balance between the extracellular matrix (ECM), metabolically active cells and cellular signal mediators.6 The membrane itself is rich in collagen which is a protein responsible

for development of healthy joints and skin elasticity, and as we age our bodies produce less and find it equally difficult to continuously produce collagen. Therefore, with chronic wounds in older adults, AM offers a healthy and rich amount of collagen for skin regrowth and elasticity. This includes collagens I, III, IV, V, and VII. In addition, AM provides ECM, elastin, laminin, fibronectin, proteoglycans, and glycosaminoglycans as well as non-viable cells.7 As a matter of fact, AM provides over 200 natural bioactive proteins that are preserved within.8-10 AM itself is a thin and transparent lining of the chorionic layer of the placenta which comprises of two primary layers; an outer layer formed by the trophoblast and an inner layer that is formed by the somatic mesoderm.

This allows AM to behave as a bioactive matrix that promotes fibroblasts and endothelial cell production. AM also promotes hematopoietic, mesenchymal and diabetic adipose stem cell migration.11 Combining all efforts, this results in cell proliferation, migration and biosynthesis.12-13 One study found that the combination method of SOC and AM resulted in an improved healing rate for patients with diabetic foot ulcers, in comparison to the use of SOC alone.14 However, not all chronic wounds result in a complete healing when using amniotic membrane as a method of treatment despite the advantages.

Methods Figure 1: 1a: Diabetic foot ulcer.

1b: Venous leg ulcer.

1a

© Copyright. Wound Masterclass. 2023 Images licenced from Adobe Stock. Credit: ZayNyi, dragancfm

1b

In this retrospective study between 2018 2021, 23 patients treated by practitioners from Professional Wound Specialists were identified as meeting the inclusion criteria. The age range was from 33 to 89 years of age, 11 of the ulcers were proven to be diabetic foot ulcers, and a further twelve were identified as Venous Leg Ulcer (VLU) patients. The ratio of male to female patients was 18:5. All participants received 5-weeks of SOC followed by 5-weeks of AM applications. They were excluded if any of the following criteria were present:

Wound Masterclass - Vol 2 - December 2023

13

Optimizing Non-Healing Venous Leg Ulcers and Diabetic Foot Ulcers: Standard of Care vs Amniotic Membrane The administration of SOC treatment over the first 5-weeks is performed according to the guidelines suggested by the National Center for Biotechnology Information. The treatment options include silver gel, silver or calcium alginate, medical honey, collagenase, antibiotic ointment, negative pressure wound therapy (NPWT) amongst other treatment modalities.

The choice of dressing is determined based on drainage percentage and whether the wound is emitting an odor. If the wound size change is insignificant after 5 weeks with SOC, AM is performed once weekly with no local or general anesthetic required for administration.

Exclusion Criteria Wound healing occurred within less than 5-weeks of AM applications Non-compliant patients resulting in an early termination of the study HbA1c of >10 in DFU patients Wounds presenting outwith the proliferation phase (i.e., infections) Disruption in the study such as acute changes to the participants medical status that resulted in a transfer of care

Table 4

Table 1 DFU Patients

Measurement 1

Measurement 2

Measurement 3

1

9 cm

8.7 cm

5.2 cm

2

2

2

15 cm

2

29.2 cm

27 cm2

3

12.5 cm2

14.3 cm2

5.1 cm2

4

16 cm2

16.8 cm2

14 cm2

5

37.8 cm2

39.1 cm2

15.6 cm2

6

12.3 cm2

12.3 cm2

7.8 cm2

7

36 cm2

38.2 cm2

31.5 cm2

8

29.9 cm2

34 cm2

4 cm2

9

19.5 cm2

18.6 cm2

9 cm2

10

12.3 cm2

16 cm2

3.6 cm2

11

9.9 cm2

12 cm2

8.4 cm2

Total Average

19.1 cm2

21.6 cm2

11.9 cm2

2

VLU Patients

% size change after SOC

% size change after AM treatment

1

-3%

-40%

2

195%

-7%

3

114%

-64%

4

105%

-17%

5

103%

-60%

6

100%

-37%

7

106%

-17%

8

114%

-88%

9

-5%

-52%

10

130%

-77%

11

121%

-30%

Total Average

113%

-45%

DFU Patients

% size change after SOC

% size change after AM treatment

1

100%

-60%

2

Table 2

Table 5

VLU Patients

Measurement 1

Measurement 2

Measurement 3

1

36 cm2

36 cm2

14.4 cm2

2

12.3 cm2

12 cm2

6 cm2

3

21 cm2

23.4 cm2

8.6 cm2

2

-2%

-50%

111%

-63%

4

33.1 cm2

31.3 cm2

4 cm2

3

5

38 cm2

28.5 cm2

15 cm2

4

-5%

-88%

6

28 cm2

15 cm2

8.4 cm2

5

-25%

-47%

7

28.6 cm2

27.6 cm2

16.8 cm2

6

-46%

-44%

8

28 cm2

18 cm2

7.6 cm2

7

-3%

-39%

9

26.9 cm2

30 cm2

18 cm2

8

-36%

-58%

10

14 cm2

22.1 cm2

10.5 cm2

9

112%

-40%

11

18 cm2

18 cm2

1.3 cm2

10

158%

-52%

12

7.3 cm2

8.4 cm2

1.8 cm2

11

100%

-93%

Total Average

19.1 cm2

21.7 cm2

9.4 cm2

12

115%

79%

Total Average

-11%

-57%

Table 3

14

DFU + VLU

Measurement 1

Measurement 2

Measurement 3

Total Average

21.8 cm

21.6 cm

10.6 cm2

2

2

Wound Masterclass - Vol 2 - December 2023

© Copyright. Wound Masterclass. 2023

Optimizing Non-Healing Venous Leg Ulcers and Diabetic Foot Ulcers: Standard of Care vs Amniotic Membrane Figure 2: Amniotic product.

Table 6 DFU + VLU

% size change after SOC

% size change after AM treatment

Total Average

-1%

-51%

Table 7 Wound Type

N t score Two-tailed P-value

DFU

9 -3.63 0.0055

VLU

12 -4.66 0.0006

Total

21 -5.93 0.0001

Table 8 DFU Wound Area Measurements (cm2)

VLU Wound Area Measurements (cm2)

Patient

Initial size

After 5 weeks of SOC Treatment and Start of AM Treatment

5 weeks after AM & SOC Treatment

Patient

Prior to SOC Treatment

After 5 weeks of SOC Treatment and Start of AM Treatment

5 Weeks after AM & SOC Treatment

1

9

8.7

5.226

10

36

36

14.4

2

15

29.16

27

11

12.25

12

6

3

12.5

14.31

5.1

12

21

23.4

8.55

4

16

16.8

14.04

13

33.06

31.27

4

5

37.82

39.06

15.6

14

37.96

28.52

15

6

12.25

12.25

7.84

15

28

15

8.4

7

36

38.22

31.54

16

17.64

16.8

28.6

8

29.88

34

4

17

28

18

7.6

9

19.5

18.6

9

18

26.88

30

18

19

14

22.08

10.5

20

18

18

1.25

21

7.29

8.4

1.8

13.26

Mean

23.34

22.41

9.16

9.96

SD

9.81

8.43

Mean

20.88

23.46

SD

10.86

11.73

Total (N=23) Mean

22.29

The treatment protocol for AM application is to clean the wound bed and prepare the area for administration of the product. Debris was then removed, and curettage of the site was performed to ensure a clean and moist wound bed. AM was placed followed by a mesh and secured with steristrips. A secondary dressing was then applied to secure and maintain a balanced moisture environment for the wound bed. The procedure was repeated once weekly for the 5-week duration period. When collecting the data for this study, the initial measurements with SOC was recorded followed by 5 weeks of SOC treatment or the start of the AM treatment and then finally after 5 weeks of the subsequent AM treatment.

© Copyright. Wound Masterclass. 2023 Image licenced from Adobe Stock. Credit: Надія Коваль

22.41

5.44 10.92

Figure 3: Wound area measurement.

Wound Masterclass - Vol 2 - December 2023

15

Optimizing Non-Healing Venous Leg Ulcers and Diabetic Foot Ulcers: Standard of Care vs Amniotic Membrane

“When we look at the matrix of AM as a material with the epithelial and mesenchymal cells that possess characteristics of pluripotent stem cells (a capability to differentiate into all three germ layers), there is a distinctive indication for its usage.”

Data Analysis After the data was collected for the three measurements, the ulcer healing process was accessed using a percentage of healed wound area for the measurable outcome. The comparison was between the percentage of healing when SOC was administered, and the difference after AM application.

When reviewing the patients with diabetic foot ulcers, the average initial size of wound was 19.1 cm2. After the initial treatment with SOC, the findings indicated an increase in measurement on average to around 21.6 cm2. However, after the administration of AM, there was a substantial decrease in the average to 9.4 cm2. decrease in the average to 9.4 cm2. This indicated an overall reduction percentage of -45%, thus proving the effectiveness of AM treatment for this type of chronic wound. In the VLU patients, the initial average size of the wound was around 24.3 cm2. There was then a slight decrease to 21.6 cm2 after the treatment with SOC. This indicated a reduction percentage of -11%. AM treatment was then administered, and a significant reduction was seen again as the wounds measured – on average – 9.4 cm2.

Another substantial decrease in the wound size of around-57% after treatment course.

Discussion In this study, the experts intentionally chose challenging wounds to evaluate the efficacy of AM treatment, as demonstrated in the inclusion/ exclusion criteria for those with DFU and those with VLU. In both clinical wound types, the patients responded to the SOC treatment at a refractory rate that showed minimal change, and in some instances the wound responded by increasing in size. This is a clear indication for considering new modalities for treatment as the efficacy of SOC cannot be reproduced, or continued with in most cases as that will result in further wound deterioration and potential

16

Wound Masterclass - Vol 2 - December 2023

risk factors presenting like inflammation or proliferation of the wound itself. However, comparatively once the patients received the AM treatment in combination with SOC there was a significant improvement and overall greater response that led to wound healing and a decrease in the total surface area of the wound; seen in both DFU and VLU patients.

This substantial difference therefore supports the efficacy of the treatment.

Another discussion around the usage of AM treatment proposed that it can be used as a skin substitute and reconstructive option for treating deeper dermal wounds and full thickness wounds.15 In this study, the purpose of the AM is to scaffold and provide a cell source that has the same histological and physiological components as the skin. Therefore, when we look at the matrix of AM as a material with the epithelial and mesenchymal cells that possess characteristics of pluripotent stem cells (a capability to differentiate into all three germ layers), there is a distinctive indication for its usage. The study approved and acknowledged the properties of AM and its likeness to skin as an enriched cell that contains a scaffolding structure that could be translated into clinical management.

csqbio.com

Supported by

© Copyright. Wound Masterclass. 2023

Optimizing Non-Healing Venous Leg Ulcers and Diabetic Foot Ulcers: Standard of Care vs Amniotic Membrane

References 1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6798798/#:~:text=Current%20 standard%20 of %20care%20(SOC,depending%20on%20wound%20location%20and 2. https://pubmed.ncbi.nlm.nih.gov/22592624/ 3. Dreifke, M. B., Jayasuriya, A. A., & Jayasuriya, A. C. (2015). Current wound healing procedures and potential care. In Materials Science and Engineering C (Vol. 48) https:// doi.org/10.1016/j.msec.2014.12.068 4. Elheneidy, H., Omran, E., Halwagy, A., Al-Inany, H., Al-Ansary, M., & Gad, A. (2016).

Amniotic membrane can be a valid source for wound healing. International Journal of Women’s Health, 8. https://doi.org/10.2147/IJWH.S96636 5. Kogan, S., Sood, A., & Granick, M. S. (2018). Amniotic Membrane Adjuncts and Clinical Applications in Wound Healing: A Review of the Literature. In Wounds : a compendium of clinical research and practice (Vol. 30, Issue 6) 6. Schultz GS, Davidson JM 7. Koob TJ, Lim JJ, Zabek N, Massee M. Cytokines in single layer amnion allografts compared to multilayer amnion/chorion allografts for wound healing. J Biomed Mater Res B Appl Biomater 2015 Jul;103(5):1133-40.

8. Koob TJ, Rennert R, Zabek N, Massee M, Lim JJ, Temenoff JS, Li WW, Gurtner G. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013 Oct;10(5):493-500.

9. Koob TJ, Lim JJ, Massee M, Zabek N, Denoziere G. Properties of dehydrated human amnion/ chorion composite grafts: Implications for wound repair and soft tissue regeneration. J Biomed Mater Res B Appl Biomater. 2014 Aug;201(6):1353-62.

10. Koob TJ, Lim JJ, Massee M Zabek N, Rennert R, Gurtner G, Li WW. Angiogenic properties of dehydrated human amnion/chorion allografts: therapeutic potential for soft tissue repair and regeneration. Vasc Cell. 2014 May 1;6:10.

11. Wu Qianqian et al. Comparison of the proliferation, migration and angiogenic properties of human amniotic epithelial and mesenchymal stem cells and their effects on endothelial cells. Int J Molecular Med Feb-2017 Vol 39 Issue 4 918-26.

12. Maan ZN, Rennert RC, Koob TJ, Januszyk M, Li WW, Gurtner GC, Cell recruitment by amnion chorion grafts promotes neovascularization. J Surg Res. 2015 Feb;193(2):953-62.

13. Massee M, Chinn K, Lim JJ, Godwin L, Young CS, Koob TJ. Type I and II Diabetic Adipose-Derived Stem Cells Respond In Vitro to Dehydrated Human Amnion/Chorion Membrane Allograft Treatment by Increasing Proliferation, Migration, and Altering Cytokine Secretion. Adv Wound Care (New Rochelle). 2016 Feb 1;5(2):43-54.

14. Irakoze L, et al. Efficacy and time sensitivity of amniotic membrane treatment in patients with diabetic foot ulcers: a systematic review and meta-analysis. Diabetes Therapy. 2017;8(5):967-79 15. Farhadihosseinabadi B, Farahani M, Tayebi T, Jafari A, Biniazan F, Modaresifar K, Moravvej H, Bahrami S, Redl H, Tayebi L, Niknejad H. Amniotic membrane and its epithelial and mesenchymal stem cells as an appropriate source for skin tissue engineering and regenerative medicine. Artif Cells Nanomed Biotechnol.

2018;46(sup2):431-440. doi: 10.1080/21691401.2018.1458730. Epub 2018 Apr 24. PMID: 29687742.

Alyssa Flores | President & CEO / CSQ Bio A trusted partner in the regenerative medicine and biologics industry With a team of distributors & agents throughout the United States, and soon to be international, Alyssa launched CSQ Bio™ in 2017 with the goal of bringing life changing products, therapies, and education to providers and medical experts at national hospitals, surgery centers, private practice facilities & mobile health care. Her passion is sourcing high quality, innovative products by building solid distribution channels to provide regenerative medicine & biologics to patients who are in need of wound care / wound healing.

Today, CSQ Bio represents some of the best technology in the world. Soon to launch not only in the USA, but in Europe, Asia and Canada, it is a very unique autologous skin graft that will promote chronic wound healing utilizing the patient's own cells, delivered to the patient on the spot. To learn more, please contact Alyssa Flores | alyssa@csqbio.com | 602-769-1017 | WhatsApp

csqbio.com Supported by

© Copyright. Wound Masterclass. 2023

Wound Masterclass - Vol 2 - December 2023

17

Masterclass GUIDES Introduction This Masterclass guide is a concise overview aimed at exploring the use of SomaGen® and how to incorporate this into your practice.

What Is SomaGen®?

Allograft Dermal Matrix SomaGen® Keywords

■ Allograft ■ Venous leg ulceration ■ Diabetic foot ulcers

■ Ulcers ■ Wound healing

Figure 1: Different sizes of SomaGen®

■ SomaGen® Meshed supports treatment for large and complex wounds

■ The lattice-based slit design allows the graft to conform and expand based on the wound size and topography

■ Acellular human reticular dermal allograft ■ Eliminates autologous skin grafting need ■ Compatible with other common advanced wound modalities ■ Large slits ensure wound fluid egress while allowing the

How Does SomaGen® Work ?

1.

Prepare the graft: To prepare SomaGen® Meshed, first, remove the non-sterile outer pouch by peeling from the chevron seal side, then present the sterile inner pouch to the practitioner within the sterile field. Peel the inner pouch from the chevron seal side, and using sterile forceps, grasp the SomaGen® Meshed. Rinse the SomaGen® Meshed by submerging it in sterile saline or another isotonic solution.

2.

Prepare the Wound: Debride wound as necessary to ensure edges and base contain viable tissue prior to placement of SomaGen Meshed.

3.

Place Graft on Wound: Grafts are provided in four different size options that can expand to accommodate a variety of wound sizes. Apply graft on wound in a single layer ensuring no folds.

Ensure maximal wound bed contact and tension-free fixation.

4.

Secure the Graft: Anchor graft with sutures (4a), staples (4b), or other suitable alternative. Anchor points should be approximately 1cm apart. Additional sutures on graft may be added to maintain full contact with wound surface. Any tears can be repaired via suturing.

5.

Apply Standard Dressings: Apply a permeable non-adherent dressing directly on top of graft. Ensure dressing prevents shearing forces and maintains contact between graft and wound.

patient’s own cells to rebuild tissue

■ Meshed pattern allows the graft to stretch significantly from its original size, providing flexibility and conformity to the needs of the wound

Figure 2: SomaGen® Meshed

■

1

Wound Masterclass - Vol 2 - December 2023

NOTE: When graft is used with Negative Pressure Wound Therapy (NPWT), a permeable non-adherent dressing may be an option, at the discretion of the clinician. NPWT dressings may be applied. If without NPWT, apply appropriate secondary dressings to maintain a moist wound healing environment.

Masterclass GUIDES

Allograft Dermal Matrix SomaGen® What Types of Wounds Are Suitable?

What Types of Wounds Are Not Suitable?

■

Replacement of damaged or inadequate integumental tissue

Local or systemic infection

■ ■ ■

Diabetic foot ulcers

■ ■ ■ ■ ■ ■ ■ ■ ■

Inability to cooperate with and/or comprehend post-operative instructions, and infected or nonvascular surgical sites

Venous leg ulcers Pressure ulcers or for other homologous use

Inflammatory response of non-infectious cause Uncontrolled diabetes Low vascularity of the surrounding tissue Mechanical trauma Pregnancy Poor nutrition or poor general medical condition Dehiscence and/or necrosis due to poor revascularization

Warnings and Cautions

■ ■ ■ ■ ■ ■

Do not sterilize Do not freeze No known sensitizing agents are present in this tissue SomaGen® Meshed is packaged in an ethanol solution and must be rinsed in a sterile solution prior to implantation Care should be taken when using SomaGen® Meshed in conjunction with electrical equipment NOTE: No antibiotics were used during the processing of this tissue.Extensive medical screening procedures have been used in the selection of all tissue donors for MTF (please see Donor Screening and Testing). Transmission of infectious diseases may occur despite careful donor selection and Laboratory testing, including serology and nucleic acid testing (NAT)

Figure 3: SomaGen® Meshed

Figure 4: SomaGen® Meshed packaging

Wound Masterclass - Vol 2 - December 2023

2

Masterclass GUIDES

Allograft Dermal Matrix SomaGen®

What Is the Evidence?

The crossover study showed a high healing rate (83%) among patients who received the HR-ADM with SOC who had failed to heal with SOC alone in the RCT. The mechanism by which the reticular dermis stimulates healing has yet to be fully investigated. However, with the results showing such marked success of the HR-ADM application, this novel approach may provide a cost-effective technology to treat patients with difficultto-heal DFUs.1

Efficacy

■ Aseptically processed pre-

meshed HR-ADMs have an open architecture which allowed human fibroblasts and endothelial cells to readily attach and proliferate. The cells were able to secrete new ECM proteins that support granulation activities. Render series imaging showed that the cells infiltrated through the dermis over time.

Furthermore, day 14 data showed cells bridging between meshed gaps. This type of infiltration and integration can support surgical wound closure. In addition, the secretion of angiogenic growth factors by the cells can help facilitate revascularization in a surgical wound environment2

3

Wound Masterclass - Vol 2 - December 2023

Pain

■ Possible adverse effects of using ADM include but are not limited to: local or systemic infection, dehiscence and/ or necrosis due to poor revascularization and a specific or nonspecific immune response to the graft

Debridement

■ SomaGen® Meshed, and its

biocompatible design, provides immediate wound coverage without the need for autologous skin grafting, lowering costs & saving time - all without compromising patient outcomes

Masterclass GUIDES

Allograft Dermal Matrix SomaGen® Key Points

■ SomaGen® Meshed: Features biocompatible design ■ Immediate wound coverage: No autologous skin grafting needed ■ Advantages: Reduces costs and saves time ■ Patient outcomes: Maintained without compromise References 1. Phipps, A., Vaynshteyn, E., Kowalski, J. B., Ngo, M. D., Merritt, K., Osborne, J., & Chnari, E. (2017, August 10). Chemical sterilization of allograft dermal tissues. Cell and Tissue Banking, 18(4), 573–584. https://doi.org/10.1007/s10561-0179647-0 2. Zelen, C. M., Orgill, D. P., Serena, T. E., Galiano, R. E., Carter, M. J., DiDomenico, L. A., Keller, J., Kaufman, J. P., & Li, W. W. (2018, April 22). An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow-up trial. International Wound Journal, 15(5), 731–739. https://doi.org/10.1111/iwj.12920

Useful Links

Use your device to scan this QR code for more information about SomaGen®

Visit the MTF Biologics website mtfbiologics.org

How to Cite this Article Masterclass Guide: Allograft Dermal Matrix: SomaGen® Wound Masterclass. Volume 2. No 6. December 2023

SPONSORED BY MTF BIOLOGICS

Wound Masterclass - Vol 2 - December 2023

4

Evolution of Dressing Change Frequency for Patients with Wounds Editorial Summary Wound dressing change frequency is a critical aspect of wound management. Historically, it relied on empirical observations, but evidence-based practices have evolved with advancements in wound care. Factors like wound type, depth, exudate levels, infection risk, and patient health influence dressing change frequency. Current best practices emphasize personalized care, regular assessments, advanced dressings, and patient education. Adopting evidence-based guidelines can optimize dressing change frequency and improve patient outcomes in wound healing.

Introduction

T

he management of wounds has evolved significantly over the years, and one crucial aspect is the frequency of dressing changes. Dressing change frequency plays a vital role in wound healing, as it directly impacts the patient’s comfort, wound infection rates, and overall healing process. In this article, we will explore the historical progression and the current best practices in dressing change frequency for patients with wounds.

Historical Background In the past, dressing change frequency was largely based on empirical observations, and there was a lack of scientific evidence to support specific intervals. Dressings were often changed daily or even multiple times a day, under the belief that frequent changes would promote wound healing. However, it was later realized that this practice might lead to unnecessary disturbance of the wound bed, causing additional trauma and potentially hindering the healing process.

Advancements in Wound Care

Dr Negin Shamsian Consultant Plastic & Reconstructive Surgeon (Locum) Chief Editor of Wound Masterclass

22

With advancements in wound care research and technology, a shift occurred towards evidencebased practices. The concept of ‘moist wound healing' gained popularity, which advocates maintaining a moist environment around the wound to facilitate cellular activities and minimize tissue damage. This shift led to the recognition that dressing change frequency should be adjusted based on the wound characteristics and healing trajectory.

Wound Masterclass - Vol 2 - December 2023

Factors Influencing Dressing Change Frequency Several factors influence the dressing change frequency for patients with wounds: Wound Type and Depth Different wound types, such as acute, chronic, surgical, or traumatic, require varying approaches to dressing changes. The depth of the wound also affects the frequency, with deeper wounds generally requiring less frequent changes to prevent disruption of the delicate healing processes.

Exudate Levels The amount of wound exudate, or drainage, is a crucial factor in determining dressing change frequency. Highly exuding wounds may necessitate more frequent changes to avoid saturation and maintain a moist environment.

Infection Risk Infected wounds often require more frequent dressing changes to manage the bacterial load and prevent complications. Dressing change frequency may decrease as the infection resolves.

Patient Factors The overall health and individual patient needs, such as age, comorbidities, and mobility, influence the dressing change frequency.

Patients with compromised immune systems or impaired healing may require more frequent

© Copyright. Wound Masterclass. 2023

Evolution of Dressing Change Frequency for Patients with Wounds

“By carefully assessing wound characteristics and individual patient needs, healthcare providers can optimize dressing change frequency and contribute to improved patient comfort and better healing results.”

changes.

Utilizing Advanced Dressings

Best Practices in Dressing Change Frequency

Modern wound care has introduced a wide range of advanced dressings that can stay in place for more extended periods, reducing the need for frequent changes. These dressings provide an optimal moist wound healing environment and help to promote faster healing.

Currently, evidence-based guidelines recommend a more personalized approach to dressing change frequency. The focus is on optimizing wound healing while minimizing unnecessary interventions. Some best practices include: Assessment and Reassessment Regular and thorough wound assessments are essential to determine the appropriate dressing change frequency. Reassessment should occur whenever there are changes in wound characteristics or the patient’s condition.

Individualized Care Tailoring the dressing change frequency to each patient’s specific needs is crucial. Consideration should be given to wound type, exudate levels, infection status, and the patient’s overall health.

Patient Education Engaging patients in their wound care and providing proper education on signs of infection, dressing maintenance, and when to seek medical attention empowers patients to take an active role in their healing process.

Conclusion The evolution of dressing change frequency for patients with wounds reflects a shift towards evidence-based practices and a more personalized approach to wound care. As healthcare professionals, it is essential to stay updated with the latest research and guidelines to provide optimal wound healing outcomes for patients. By carefully assessing wound characteristics and individual patient needs, healthcare providers can optimize dressing change frequency and contribute to improved patient comfort and better healing results.

References 1. Winter GD. Formation of the scab and the rate of epithelization of superficial wounds in the skin of the young domestic pig. Nature. 1962;193(4812):293-294.

2. Thomas S. The role of dressings in wound infection. Prof Nurse. 1999;15(4):227-231.

3. Schultz GS, Sibbald RG, Falanga V, et al. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003;11 Suppl 1:S1-S28.

4. Baranoski S, Ayello EA. Wound Care Essentials: Practice Principles. 4th ed. Lippincott Williams & Wilkins; 2012.

5. Romanelli M, Dini V, Bertone MS, et al. Randomized comparison of silver-coated dressing (Acticoat®) and chlorhexidine acetate 0.5% (Bactigrass®) in the topical treatment of partial thickness burns. Burns. 2005;31(7):875-881.

6. Moore Z, Cowman S. Conquering pressure ulcer pain: Evaluating the use of a soft silicone wound contact layer. Br J Nurs. 2012;21(13):S14, S16-S17.

7. Vuerstaek JD, Vainas T, Wuite J, Nelemans P, Neumann MH, Veraart JC. State-of-the-art treatment of chronic leg ulcers: A randomized controlled trial comparing vacuum-assisted closure (V.A.C.) with modern wound dressings. J Vasc Surg. 2006;44(5):1029-1037.

© Copyright. Wound Masterclass. 2023

8. White R. The role of occlusive dressings in the healing of split-skin graft donor sites. J Wound Care. 1998;7(10):503-507.

9. Waring MJ, Parsons D. Physico-chemical characterisation of carboxymethylated spun cellulose fibres. Biomaterials. 2001;22(9):903-912.

10. Cutting KF, White RJ. Maceration of the skin and wound bed 1: its nature and causes. J Wound Care. 2002;11(7):275-278.

11. Ovington LG. Hanging wet-to-dry dressings out to dry. Adv Skin Wound Care.

2002;15(2):79-86.

12. Wang JT, Chang SC, Ko WJ, Chang YS. Removal of adherent skin bacteria in the normal external auditory canal. Laryngoscope. 1999;109(4):597-601.

13. Beldon P. How safe are adhesive wound dressings in elderly care? J Wound Care.

2001;10(7):289-290.

14. Chaby G, Senet P, Vaneau M, et al. Dressings for acute and chronic wounds: a systematic review. Arch Dermatol. 2007;143(10):1297-1304.

15. International Skin Tear Advisory Panel. ISTAP Wound Consensus Update: Wound Bed Preparation in Practice. Wounds International; 2016.

Wound Masterclass - Vol 2 - December 2023

23

Jump-starting Healing in Venous Leg Ulcers: Should Electrical Stimulation be Considered in Synergy with Compression Therapy?

Editorial Summary High-quality evidence to guide treatment selection of chronic wounds remains lacking. The conventional parallel-arm randomized controlled trial (RCT) model for wound healing studies has limitations. Complete wound closure as a primary endpoint necessitates trials with large sample sizes and prolonged follow-up to achieve adequate statistical power. Such trials are logistically difficult to conduct and may fail to detect more modest treatment effects on wound healing kinetics. Novel metrics have been suggested such as percentage area reduction (PAR) over a 4-week period as a surrogate endpoint. The Food and Drug Administration (FDA) now recognizes PAR as a potential primary endpoint for registrational wound healing trials. PAR following a linear trajectory over time, allows more granular detection of changes in wound healing rate. The self-controlled study model leverages within-patient comparisons, thereby removing potential confounding from between-patient differences. A recent two-phase study of 60 patient with VLUs provides a salient example of this trial design. There was an initial 4-week run-in phase with standard compression therapy alone. Patients were then randomized to continue compression alone or add adjunctive neuromuscular electrical stimulation (NMES) for an additional 4 weeks. The addition of NMES significantly increased the PAR rate compared to compression alone in the same patient cohort (p=0.016). Meanwhile, the control group’s healing rate was unchanged between study phases. These findings demonstrate the feasibility of employing PAR and within-patient controls to efficiently discriminate treatment effects with a limited sample size over a 2-month study duration. The design of wound healing trials has been constrained by overreliance on complete wound closure in large cohorts. Metrics like PAR may provide higher quality evidence to improve wound care.

Novel Approaches in Chronic Wound Healing Research

C

hronic wounds, such as venous leg ulcers (VLUs), impose a substantial global disease burden, with costs exceeding $14 billion annually in the United States alone.1 Yet, there is a dearth of high-quality evidence supporting effective treatments.

The conventional randomized controlled trial (RCT) model employed in wound healing research is fraught with significant limitations that impede the efficient assessment of new therapies. Relying on complete wound closure as the primary outcome necessitates protracted, large-scale trials that pose logistical challenges and frequently fail to detect treatment effects.

Consequently, there have been calls to question this conventional wisdom by embracing alternative metrics and study designs better suited to evaluating healing rates over shorter timeframes.

Shortcomings of the Conventional RCT Model

Dr Keith Gordon Harding Welsh Wound Innovation Centre Pontyclun, United Kingdom

24

The customary RCT protocol, which compares complete healing between groups, renders wound healing studies particularly arduous.

The extreme heterogeneity of chronic wounds makes it challenging to match intervention and control groups. Furthermore, the binary nature of the complete healing outcome lacks statistical power compared to quantitative metrics. Thus, demonstrating significant differences between groups mandates following large patient cohorts over many months, leading to exorbitant costs, high dropout rates, and delayed results.

Wound Masterclass - Vol 2 - December 2023

A systematic review in 2016 identified only two interventions with significant evidence from RCTs - compression and pentoxifylline. Out of thousands of wound therapy studies, merely 48 RCTs met the criteria for quality, and only eight yielded stand-alone findings of effectiveness.

This glaring scarcity of high-quality evidence primarily stems from the methodological challenges intrinsic to the conventional RCT design for wound healing.

Firstly, the cohort comparison framework is unable to overcome inter-patient variations in wound chronicity, size, microbiome, comorbidities, adherence, and other confounding factors. Achieving matching intervention and control groups is unattainable given this heterogeneity. Secondly, complete healing is inherently a binary outcome - either achieved or not. Analyzing such binary data using frequency statistics lacks sensitivity compared to quantitative metrics capable of assessing the degree of change. Thirdly, the protracted follow-up required until a sufficient number of wounds achieve complete closure makes maintaining subject engagement and ensuring consistent assessment over months of treatment challenging.

Alternative Metrics and Study Designs In recent years, experts have proposed addressing these issues by embracing alternative primary endpoints and study models.

Continuous Metrics of Healing Rate Instead of focusing on final complete closure,

Jump-starting Healing in Venous Leg Ulcers: Should Electrical Stimulation be Considered in Synergy with Compression Therapy?

“The primary outcome was PAR over each 4 week phase, rather than final complete closure. The addition of NMES significantly increased the PAR healing rate compared to compression alone for the same patients.”

assessing intermediate outcomes related to the healing rate could offer greater statistical power.

Metrics such as wound area, volume, depth, or diameter changes over a fixed period can be analyzed as continuous variables to detect significant differences with fewer subjects and shorter durations. In 2020, the FDA suggested percentage area reduction (PAR) over 4 weeks as a potential primary endpoint for wound trials.

PAR has been shown to follow a consistent linear trajectory during this timeframe, enabling the quantification of changes in the healing rate after introducing an intervention.

Self-Controlled Study Designs Rather than cohort comparisons, self-controlled models eliminate between-patient confounding by conducting within-patient comparisons.

Each subject serves as their control. Variations include split-body comparisons, contralateral controls, or pre-post-treatment assessments of the same wound. The pre-post self-controlled approach compares the initial baseline healing rate over weeks with a subsequent treatment phase healing rate for the same wound. This allows the detection of differential effects of the new treatment while controlling for all stable patient factors. By removing confounders, self-controlled studies can identify significant differences with far fewer subjects and shorter durations.

Feasibility of New Approaches A VLU trial conducted in 2021 illustrated the potential of employing PAR and a pre-post selfcontrolled design to efficiently discern treatment effects. This trial compared compression alone versus the addition of neuromuscular electrical stimulation (NMES) for 60 patients over an 8 week period. The two-phase structure involved a 4 week control run-in period with compression alone to establish a baseline healing trajectory. Subsequently, patients were randomized to either continue with compression

alone or add NMES for another 4 weeks. By comparing each patient’s healing rate between phases, confounding variables were intrinsically controlled.

The primary outcome was PAR over each 4 week phase, rather than final complete closure.

The addition of NMES significantly increased the PAR healing rate compared to compression alone for the same patients. Meanwhile, the control group’s PAR rate remained unchanged between phases. This exemplifies how a smaller number of patients studied over a shorter duration can yield statistically significant results when using PAR and within-patient controls, as opposed to relying solely on complete healing cohorts.

New Approaches to Overcome Conventional RCT Limitations The implementation of alternative metrics and self-controlled designs can help address the principal limitations of the traditional RCT approach to wound healing research.

Overcoming Patient Heterogeneity

and

Wound

Self-controlled studies eliminate confounding by comparing outcomes for the same patient, thereby controlling for individual characteristics that may influence healing, such as age, comorbidities, nutritional status, microbiome, wound location, etc. Comparing the same wound over time also accounts for differences in chronicity, area, depth, tissue type, vascular supply, and other wound factors.

Enhancing Statistical Quantitative Metrics

Power

with

PAR provides a continuous variable metric that is amenable to sensitive parametric statistics.

This enhances the ability to discern differential effects with smaller sample sizes compared to

Wound Masterclass - Vol 2 - December 2023

25

Jump-starting Healing in Venous Leg Ulcers: Should Electrical Stimulation be Considered in Synergy with Compression Therapy?

“The wider adoption of these approaches necessitates addressing certain considerations related to blinding, validity, recruitment, and regulatory acceptance.”

binary complete healing outcomes. Assessing the degree of change, rather than solely focusing on whether healing is achieved or not, better reflects clinical reality where any acceleration of healing is considered beneficial.

Improving Logistical Shorter Trials

Feasibility

with

The 4 week PAR endpoint allows for trials as short as 8 weeks, as opposed to the months required for complete closures. Greater feasibility results from quicker enrollment, better subject retention over weeks rather than months, consistent wound assessment over a shorter period, and faster acquisition of results.

Additional Implementation Considerations The wider adoption of these approaches necessitates addressing certain considerations related to blinding, validity, recruitment, and regulatory acceptance. While blinding the intervention assignment may be challenging when patients can discern whether they are receiving electrical stimulation, it is still possible to blind wound assessments using standardized photography and assessors unaware of the treatment phase. Questions remain regarding the external validity and generalizability of results from self-controlled trials with limited patient populations. Nonetheless, patient cohorts should be sufficiently large to empower the detection of clinically meaningful differences in healing rates, and the inclusion of diverse wound chronicities and types would enhance generalizability.

Efficient recruitment and retention are pivotal for feasibility. Stringent inclusion and exclusion criteria may minimize heterogeneity but could hinder recruitment. These criteria could be broadened to some extent, provided they do not significantly affect the magnitude of withinpatient confounding. While self-controlled designs conceptually require perfect protocol

26

Wound Masterclass - Vol 2 - December 2023

adherence and subject retention, modern statistical methods allow for intention-to-treat analysis approaches with these designs.

Finally, regulatory acceptance of PAR and selfcontrolled trials would facilitate implementation.

The FDA’s recent draft guidance endorses PAR over 4 weeks as a potential primary endpoint.

Self-controlled methods are also suitable for evaluating medical devices, as long as patients serve as their own controls.

Conclusion In conclusion, designing wound healing studies using PAR over fixed intervals as the primary outcome and analyzing them within a selfcontrolled model offers significant advantages over traditional complete healing RCTs. This approach finally furnishes the methodology necessary to efficiently generate rigorous evidence on interventions to address the substantial unmet needs of chronic wound patients. Given the immense disease burden, advancing wound care necessitates questioning conventional research practices and embracing more innovative and feasible trial designs. The success of recent trials, such as the NMES study, underscores the promise of new metrics and models. Wider adoption would expedite the acquisition of definitive evidence to enhance care and outcomes for the millions suffering from chronic wounds worldwide.

References 1. Rice JB, Desai U, Cummings AK, et al. Burden of venous leg ulcers in the United States. J Med Econom 2014;17(5):347–356.

2. Neumann HAM, Cornu-Thenard A, Junger M, et al. Evidence-based (S3) guidelines for diagnostics and treatment of venous leg ulcers. J Eur Acad Dermatol Venereol 2016;30:1843– 1875.

3. Nelson EA, Adderley U. Venous leg ulcers. BMJ Clin Evid 2016;2016:1902.

4. Godwin M, Ruhland L, Casson I, et al. Pragmatic controlled clinical trials in primary care: The struggle between external and internal validity. BMC Med Res Methodol 2003;3:28; doi: 10.1186/ 1471-2288-3-28 5. Eckert KA, Carter MJ. Assessing the uncertainty of treatment outcomes in a previous systematic review of venous leg ulcer randomized controlled trials: Additional secondary analysis. Wound Repair Regen 2021;29(2):327–334.

6. Robson MC, Hill DP, Woodske ME, et al. Wound healing trajectories as predictors of effectiveness of therapeutic agents. Arch Surg 2000;135:773– 777.

7. Fife CE, Eckert KA, Carter MJ. Publicly reported wound healing rates: The fantasy and the reality. Adv Wound Care (New Rochelle) 2018;7(3):77–94; doi: 10.1089/wound.2017.0743 8. Gelfand JM, Hoffstad O, Margolis DJ. Surrogate endpoints for the treatment of venous leg ulcers. J Invest Dermatol 2002;119(6):1420–1425; doi: 10.1046/j.1523-1747.2002 9. Polansky M, Van Rijswijk L. Utilizing survival analysis techniques in chronic wound healing studies. Wounds 1994;6:150–158.

10. Gault N, Castan˜eda-Sanabria J, De Rycke Y, et al. Self-controlled designs in pharmacoepidemiology involving electronic healthcare databases: A systematic review. BMC

Jump-starting Healing in Venous Leg Ulcers: Should Electrical Stimulation be Considered in Synergy with Compression Therapy?

Med Res Methodol 17: 25(2017); doi: 10.1186/s12874-016-0278-0 11. FDA Wound Healing Clinical Focus Group. Guidance for industry: Chronic cutaneous ulcer and burn wounds-developing products for treatment. Wound Repair Regen 2001;9(4):258–268.

12. Verma KD, Lewis F, Mejia M. Food and Drug Administration perspective: Advancing product development for nonhealing chronic wounds. Wound Repair Regen 2022;30(3):299–302.

13. Driver VR, Gould LJ, Dotson P, et al. Identification and content validation of wound therapy clinical endpoints relevant to clinical practice and patient values for FDA approval. Part 1. Survey of the wound care community. Wound Repair Regen 2017;25(3): 454–465; doi: 10.1111/wrr.12533 14. Driver VR, Gould LJ, Dotson P, et al. Evidence supporting wound care end points relevant to clinical practice and patients’ lives. Part 2. Literature survey. Wound Repair Regen 2019;27(1): 80–89. 15. Bull RH, Staines KL, Collarte AJ, et al. Measuring progress to healing: A challenge and an opportunity. Int Wound J 2022;19(4):734–740.

16. Aleksandrowicz H, Owczarczyk-Saczonek A, Placek W. Venous leg ulcers: Advanced therapies and new technologies.

Biomedicines 2021;9(11): 1569.

17. Bull RH, Clements D, Collarte AJ, et al. The impact of a new intervention for venous leg ulcers: A within-patient controlled trial. Int Wound J 2023 [Epub ahead of print]; doi: 10.1111/iwj .14107 18. Tucker A, Maass A, Bain D, et al. Augmentation of venous, arterial and microvascular blood supply in the leg by isometric neuromuscular stimulation via the peroneal nerve. Int J Angiol 2010;19(1):e31– e37.

19. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. BMC Med 2010; 8:18; doi: 10.1186/1741-7015-8-18 20. Sully BG, Julious SA, Nicholl J. A reinvestigation of recruitment to randomised, controlled, multicenter trials: A review of trials funded by two UK funding agencies. Trials 2013;14:166.

21. O’Meara S, Cullum N, Nelson EA, et al. Compression for venous leg ulcers. Cochrane Database Syst Rev 2012;11(11):CD000265; doi: 10.1002/14651858.CD000265.pub3 22. Eaglstein WH, Kirsner RS, Robson MC. Food and Drug Administration (FDA) drug approval end points for chronic cutaneous ulcer studies. Wound Repair Regen 2012;20(6):793–796.

23. Maderal AD, Vivas AC, Eaglstein WH, et al. The FDA and designing clinical trials for chronic cutaneous ulcers. Semin Cell Dev Biol 2012;23(9): 993–999.

24. Darwin E, Tomic-Canic M. Healing chronic wounds: Current challenges and potential solutions. Curr Dermatol Rep 2018;7(4):296– 302; doi: 10.1007/s13671-018-0239-4.

25. Va˚gesjo¨ E, Grigoleit P, Fasth A, et al. How can we optimize the development of drugs for wound healing? Expert Opin Drug Discov 2022;17(2): 93–96. 26. Gagne JJ, Fireman B, Ryan PB, et al. Design considerations in an active medical product safety monitoring system. Pharmacoepidemiol Drug Saf 2012;21(Suppl. 1):32–40.

27. Lehr AM, Jacobs WC, Stellato RK, et al. Methodological aspects of a randomized within-patient concurrent controlled design for clinical trials in spine surgery. Clin Trials 2022;19(3):259–266.

28. Birmingham TB, Marriott KA, Leitch KM, et al. Association between knee load and pain: Withinpatient, between-knees, case-control study in patients with knee osteoarthritis. Arthritis Care Res (Hoboken) 2019;71(5):647–650.

29. Melandri D, De Angelis A, Orioli R, et al. Use of a new hemicellulose dressing (Veloderm) for the treatment of splitthickness skin graft donor sites A within-patient controlled study. Burns 2006; 32(8):964–972.

30. Leshem YA, Wong A, McClanahan D, et al. The effects of common over-the-counter moisturizers on skin barrier function: A randomized, observerblind, within-patient, controlled study. Dermatitis 2020;31(5):309–315.

31. Zhang M, Sun J, Zhu M, et al. Within-patient randomised clinical trial exploring the development of microskin implantation in the treatment of pressure ulcers. Int Wound J 2022; doi: 10.1111/ iwj.14051 32. Wan F. Statistical analysis of two arm randomized pre-post designs with one post-treatment measurement. BMC Med Res Methodol 2021;21(1):150.

33. Gibelli G, Negrini M, Bruno AM, et al. Chronic effects of transdermal nitroglycerin in stable 8 BULL ET AL. angina pectoris: A within-patient, placebocontrolled study. Int J Clin Pharmacol Ther Toxicol 1989;27(9):436–441.

34. Martı´nez-Jime´nez EM, Losa-Iglesias ME, Antolı´nGil MS, et al. Flexor digitorum brevis muscle dry needling changes surface and plantar pressures: A pre-post study. Life (Basel) 2021;11(1):48.

35. Jime´nez-Garcı´a JF, Aguilera-Manrique G, ArboledasBello´n J, et al. The effectiveness of advanced practice nurses with respect to complex chronic wounds in the management of venous ulcers. Int J Environ Res Public Health 2019;16(24):5037.

36. Gault N, Castan˜eda-Sanabria J, Guillo S, et al. Underuse of self-controlled designs in pharmacoepidemiology in electronic healthcare databases: A systematic review. Pharmacoepidemiol Drug Saf 2016;25(4):372–377.

37. Dolibog P, Franek A, Taradaj J, et al. A comparative clinical study on five types of compression therapy in patients with venous leg ulcers. Int J Med Sci 2013;11(1):34–43; doi:10.7150/ijms.7548 38. Sealed Envelope Ltd. Power calculator for binary outcome superiority trial. [Online]. 2012. Available from: https://www. sealedenvelope.com/power/ binary-superiority/ [Last accessed: August 21, 2023].

39. Lucas Y, Niri R, Treuillet S, et al. Wound size imaging: Ready for smart assessment and monitoring. Adv Wound Care (New Rochelle) 2021;10(11):641–661.

woundmasterclass.com

Introducing Wound Masterclass Video

woundmasterclass.com/Video

Wound Masterclass - Vol 2 - December 2023

27

Wound Cleaning Products:

Masterclass GUIDES Introduction This Masterclass Guide is a concise overview aimed at exploring the use of Prontosan®. Prontosan® offers a specialized wound care solution comprising a cleansing solution and wound gel. Consider incorporating Prontosan® into your practice guided by individual patient needs and wound characteristics.

What Is Prontosan®?

Prontosan®

Keywords ■ Prontosan ■ Wound Care ■ Prontosan® Solution ■ Prontosan Wound Gel ■ Polyhexanide (PHMB) ®

®

■ Wound Healing ■ Wound Management ■ Ulcers ■ Burns ■ Surgical Wounds

Figure 1:

■ Prontosan® is a comprehensive wound care solution consisting of a cleansing solution and a wound gel, formulated to assist in the management and healing of various types of wounds

■ It comprises two key components: Prontosan® Solution and

Prontosan® Wound Gel. The solution is used for wound irrigation and cleansing, while the gel is applied directly to the wound bed

■ It contains polyhexanide (PHMB), an effective antimicrobial agent

that combats a broad range of microorganisms, including bacteria and fungi. It also contains betaine, which contributes to maintaining a balanced moisture level on the wound’s surface

■ It is designed to promote wound healing by creating an

How Prontosan® Works? The Ten Step Guide

environment conducive to tissue regeneration, granulation, and angiogenesis (formation of new blood vessels)

1.

Select the appropriate patient.

■ The antimicrobial action of PHMB in Prontosan® helps prevent and

2.

Examine the wound to determine its size, depth, and condition. Note any signs of infection, inflammation, or other abnormalities.

■ It helps maintain a moist wound environment, which has been

3.

Cleanse the wound using an appropriate wound cleanser or sterile saline solution. Gently remove debris, excess exudate, and any foreign particles.

■ Prontosan® Wound Gel aids in the removal of necrotic (dead) tissue

4.

Gently pat the wound area dry using sterile gauze. Avoid excessive rubbing, as it could damage delicate tissue.

■ It is suitable for various wound types, including surgical wounds,

5.

Squeeze a small amount of Prontosan® Wound Gel onto a clean, sterile surface. Use a sterile applicator or clean gloves to pick up the gel.

■ The presence of a moist gel on the wound can offer pain relief,

6.

Apply a thin and even layer of the gel directly to the wound bed.

Ensure complete coverage, especially in deeper wounds.

■ The products are typically easy to apply and integrate into wound

7.

Gently spread the gel over the wound using a sterile applicator or clean, gloved finger. Avoid applying excessive pressure that could disrupt healing tissue.

8.

Place an appropriate wound dressing over the gel to protect the wound and maintain its moist environment. Ensure the dressing covers the entire wound area and is securely in place.

9.

Record the date, time, and details of the wound care procedure in the patient’s medical records. Include information about the type of dressing used and any observations made during the process.

control infections in wounds, reducing the risk of complications that can hinder the healing process shown to accelerate healing by supporting cell migration and minimizing tissue desiccation

from the wound bed, promoting the growth of healthy tissue and assisting in wound debridement

ulcers (such as diabetic and pressure ulcers), burns, and donor sites used for skin grafts particularly in wounds with exposed nerve endings

care routines, following the guidelines provided by healthcare professionals used for skin grafts

10. Patient Follow-Up: Schedule regular follow-up appointments to assess the progress of wound healing and adjust the treatment plan as necessary.

1

Wound Masterclass - Vol 2 - December 2023

Wound Cleaning Products:

Masterclass GUIDES

Prontosan®

What Types of Wounds Are Suitable?

What Types of Wounds Are Not Suitable?

■ Surgical wounds ■ Chronic wounds ■ Pressure ulcers ■ Minor abrasions and cuts

■ Allergies ■ Sensitive Mucous Membranes ■ Internal Use ■ Severe Burns ■ Implanted Devices

■ Traumatic wounds ■ Burns ■ Venous ulcers ■ Wounds with delayed healing

■ ■ ■ ■

Underlying Medical Conditions Pregnancy and Breastfeeding Immunocompromised Individuals Underlying Skin Conditions

Adverse Effects: Chronic use may cause irritation.

Figure 2: Prontosan® wound gel

Figure 3: Prontosan® wound gel application

Figure 4: Prontosan® wound solution

Wound Masterclass - Vol 2 - December 2023

2

Wound Cleaning Products:

Masterclass GUIDES

Prontosan®

What Is the Evidence?

Clinical studies and research papers have explored various aspects of the usage of Prontosan®, including its impact on wound healing, infection prevention, pain relief, and overall wound management. These studies often involve both Prontosan® Solution and Prontosan® Wound Gel.

Efficacy

■ Wound Cleansing: Prontosan®

Solution is effective for wound irrigation and cleansing, removing debris and contaminants. It can help create a clean wound bed, which is essential for optimal healing

■ Infection Prevention: The

antimicrobial properties of Prontosan®, particularly polyhexanide (PHMB), contribute to preventing and controlling wound infections. By reducing microbial load, it supports a healthier wound environment

■ Moist Wound Healing: Prontosan®

products help maintain a moist wound environment, which is known to facilitate wound healing processes such as cell migration, angiogenesis, and granulation tissue formation

■ Debridement: Prontosan® Wound

Infection

■ The antimicrobial properties

of Prontosan®, particularly polyhexanide (PHMB), contribute to preventing and controlling wound infections. By reducing microbial load, it supports a healthier wound environment

■ For wounds that are already

infected, the antimicrobial properties of Prontosan® can help control and manage the infection. By reducing the number of microorganisms, it supports the body’s natural defense mechanisms and provides a healthier environment for healing

Costs

■ Prontosan® solution 40ml ampoule costs around £15 for the box of 24

■ Prontosan® gel 50g tube costs around £12

■ From the date of opening, the solution and gel can be used up to 8 weeks for single patient use

■ Long shelf life at ambient temperature storage (3 years after date of manufacture)

■ Prontosan® can also be used

preventively in wounds at risk of infection, such as surgical wounds or wounds with compromised immune function. It helps reduce the likelihood of infection development

Gel’s debridement properties aid in the removal of necrotic tissue, allowing for the growth of healthy tissue and promoting wound healing

■ Pain Relief: The presence of the

moist gel on the wound can provide pain relief, particularly in wounds with exposed nerve endings

Prontosan has tested efficacy on multiple species of bacteria within 60 seconds, this means Prontosan is suitable for irrigation in wounds where only planktonic bacteria is a concern.

For wounds suspected of containing biofilm, irrigation with Prontosan is shown to be more effective than other cleansers over 3 – 6 day periods, however for maximum benefit in wounds where biofilm is a possibility, an enhanced contact time is recommended. The betaine within Prontosan provides the surfactant / cleansing effect for biofilm disruption and cleansing of slough and PHMB is present as an adjuvant ingredient.

3

Wound Masterclass - Vol 2 - December 2023

Wound Cleaning Products: Prontosan®

Masterclass GUIDES

Key Points ■ It is a comprehensive wound care solution that includes solution for cleansing and wound gel for direct wound application ■ It contains polyhexanide (PHMB), an antimicrobial agent effective against a range of microorganisms, supporting infection prevention and control

■ It maintains a moist wound environment, promoting tissue regeneration, granulation, and angiogenesis, key processes in wound healing ■ Prontosan Wound Gel aids in debridement by removing necrotic tissue, while its moist presence on wounds can offer pain relief ■ It is suitable for various wound types, including surgical wounds, ulcers, burns, and donor sites, providing adaptable wound care ■ It’s antimicrobial properties help prevent wound infections by reducing microbial load and disrupting biofilm formation

There is no limit set for the treatment duration with Prontosan® Wound Irrigation Solution. In clinical trials, the longest documented treatment duration was 6 months. In fact, Prontosan® is especially designed for the long term treatment of hard-to-heal wounds. Prontosan Wound Gel and Wound Gel X should be cleansed off at every dressing change, continual contact should not exceed 30 days, most likely dressing changes occur more regularly than this and usually within 7 days.

References 1.

2.

3.

4.

Prontosan® Wound Gel [Internet]. www.bbraun.com. Available from: https://www.bbraun.com/en/products/b/prontosan-wound-gel.html Prontosan® Wound Irrigation Solution [Internet]. www.bbraun.com. Available from: https://www.bbraun.com/en/products/b/prontosan-wound-irrigation-solution-for-wounds-and-burns.html Guidance: Prontosan Solution and Gel X [Internet]. Available from: https://www.bsuh.nhs.uk/library/wp-content/uploads/sites/8/2020/08/Prontosan-Application-Brighton-and-Sussex-Final.pdf Prontosan (betaine-polyhexanide) dosing, indications, interactions, adverse effects, and more [Internet]. reference.medscape.com. Available from: https://reference.medscape.com/drug/prontosan-betaine-polyhexanide-999621

Useful Links

Use your device to scan this QR code for more information about Prontosan® wound cleaning products

Visit the B Braun website: bbraun.com

How to Cite this Article Masterclass Guide: Wound Cleaning Products: Prontosan® Wound Masterclass. Volume 2. No 6. December 2023

SPONSORED BY B BRAUN

Wound Masterclass - Vol 2 - December 2023

4

Optimising Healing in Diabetic Foot Ulcers: What is the Role of TLC-NOSF Dressings?

Editorial Summary Diabetic Foot Ulcers (DFUs) are a significant challenge to wound care clinicians1 and place a financial burden on healthcare systems globally. Annually DFUs cost the USA hundreds of billions and the UK up to £1 billion annually.1 Early referral of patients with DFUs to a specialist service improves outcomes. TLCNOSF Technology (Technology Lipido-Colloid - Nano Oligo Saccharide Factor) has a strong evidence base supporting its usage including several randomised controlled trials and some real world evidence . The purpose of this article is to explore the real world evidence of using UrgoStart dressings as first-line local treatment and part of the standard of care for the management of patients with a DFU2,3,16

Introduction

E

surgical debridement, offloading and optimising the wound condition. Standard care includes metabolic control, pressure relief (offloading), vascular assessment and control of ischaemia, wound debridement, wound dressings, and infection control measures.6-7

Background

UrgoStart dressings are recommended for the treatment of DFUs as they are associated with increased closure rate, shorter time-to-closure, and cost savings.8 They are a range of dressings with Technology Lipido-Colloid – Nano Oligo Saccharide Factor (TLC-NOSF) technology, which is a lipido-colloid healing matrix impregnated with sucrose octasulfate.2 Matrix Metalloproteinases (MMPs) may be present and play a pivotal role in both acute and chronic wounds. They regulate extracellular matrix degradation and deposition that is essential for wound reepithelialization.

vidence exists to support the recommendation for the use of UrgoStart dressings as part of standard care for the treatment of diabetic foot ulcers (DFUs). This study, evaluating routine use for DFU patients in the UK, confirmed that early intervention with evidence based local wound treatment use leads to healing in most patients, with a mean time to healing of 24 days. In 2023, NICE renewed it’s support of the UrgoStart treatment leading to increased wound healing.

Those who benefit most are those with less severe DFUs. DFUs remain a frequent and serious complication of diabetes mellitus, resulting in a variety of adverse effects for the patient and high economic cost.

Ms Michelle Goodeve Diabetes Specialist Podiatrist Chelmsford, United Kingdom

Ms Laura Saunders Podiatrist, Wound Care Specialist Essex, United Kingdom

32

DFUs are a frequent and serious complication of diabetes mellitus, characterised by a high risk of infection and amputation, impaired patient quality of life, and substantial financial burden.2 This is evident in the provided Community Interest Company (CIC) caseload which is only commissioned for high risk patients which in reality means most of the appointments available are for patients with current foot ulceration. They may result in sleep disturbance, depression and anxiety; pain and discomfort, associated with exudate leakage or malodour; restricted mobility, difficulty with daily activities and limited leisure activities.4-5 The main goal of DFU treatment is to have ulcer free days and reduce the risk of serious complications. This requires a multidisciplinary approach like vascular intervention, surgery,

Wound Masterclass - Vol 2 - December 2023

The delayed healing of chronic wounds such as DFUs, leg ulcers or pressure ulcers has been associated with an excess of matrix metalloproteinases (MMPs), present since the onset of the wounds.9 The TLC-NOSF healing matrix interacts with the wound microenvironment by limiting the deleterious action of (MMPs), which in excess leads to continuous degradation of the extracellular matrix components.

What Was the Aim of the Study?

The study aimed to evaluate the clinical outcomes for patients being treated with the UrgoStart treatment range on first intervention along with the other appropriate standards of care after implementing the UrgoStart range for

Optimising Healing in Diabetic Foot Ulcers: What is the Role of TLC-NOSF Dressings?

"UrgoStart is a range of dressings which can improve wound healing for diabetic foot ulcers and improve the rate of wound healing for venous leg ulcers. Cost modelling shows that UrgoStart is cost saving compared with standard care dressings in these groups. UrgoStart should therefore be considered as an option for people with diabetic foot ulcers or venous leg ulcers after any modifiable factors such as infection have been treated.”

DFU patients.

Figure 2: Data collection pathway.

Methods

Data Collection Pathway

The study was a prospective, observational, single-arm study in the UK, enrolling patients over an 8 week period and following them up for a maximum of 20 weeks.

UrgoStart contact and UrgoStart Plus Pad, which benefit from TLC-NOSF technology, were evaluated. UrgoStart Contact is a flexible wound contact layer dressing made of a polyester textile mesh coated with the TLCNOSF healing matrix, intended for use on wounds mainly covered with granulation tissue; while UrgoStart Plus Pad, a non-woven pad made of cohesive polyabsorbent fibres coated with a soft adherent TLC-NOSF healing matrix, is intended for use on exudative wounds, regardless of their level of sloughy tissue.

Patients were seen at the community podiatry clinic on a weekly basis for reassessment, treatment, and data capture. In the case of shared care, dressing changes were performed between clinic visits by the community nurses, the patients, or their relatives. Patients’ and wound-related characteristics were documented in a standardised case report form at baseline and every 2 weeks until wound closure, patient withdrawal from the study, or the completion of the 20-week follow-up, whichever occurred first. The following data was recorded:

■ ■ ■ ■ ■

■

Full mental capacity, and ability to give written informed consent to participate in the study

Critical limb ischaemia

Other medical history, such as amputation history, ulceration history; renal deficiency, cardiovascular disease; patient mobility, and metabolic control, with glycated haemoglobin test Patient’s health-related quality of life (HRQoL), measured with the EuroQol-visual analogue scale (EQ-VAS) Wound characteristics, such as wound duration reported in weeks; wound location (‘sole of the foot’, ‘tip of the toe’, ‘side of the foot’, ‘dorsum of the foot’, ‘other’); severity score using the SINBAD scale

Wound characteristics, including wound area and depth, wound bed tissue (percentage of necrotic, sloughy and granulation tissues); exudate levels (‘none’, ‘low’, ‘moderate’, ‘high’), and surrounding skin condition (‘healthy’, ‘dry’, ‘erythematous’, ‘macerated’, ‘eczematous’); overall wound healing assessment since the last visit (‘healed’, ‘improved’, ‘stabilised’, ‘deteriorated’)

■

Pain assessed with a VAS from 0 (no pain) to 10 (the worst pain)

■

Method of debridement, if any performed

■ ■ ■ ■

Known allergy/ hypersensitivity to the dressing

Diabetes mellitus type, peripheral neuropathy confirmed by monofilament test; peripheral arterial disease (PAD) status, confirmed by recent vascular assessment

Follow-Up Parameters

Figure 1: Exclusion criteria.

Adult patients with uninfected DFUs suitable for application of the evaluated range of dressings

Patient demographics (age, sex)

Primary and secondary dressings applied, and number of dressing changes per week Offloading device used, such as casts, devices that immobilise the ankle joint and customised shoes Occurrence of any adverse event, including the incidence of infection and the associated treatment initiated Any other relevant comments, including shared care and whether care plans were followed

At A the Final Visit

■

The patient’s Health-related quality of life (HRQOL), using the EQ visual analogue scale (EQ-VAS)

Wound Masterclass - Vol 2 - December 2023

33

Optimising Healing in Diabetic Foot Ulcers: What is the Role of TLC-NOSF Dressings?

“The highest wound closure rate was patients without peripheral arterial disease (PAD) (85% at 20 weeks), but 50% patients with PAD achieved closure by 20 weeks. Those with a Sinbad score of 1 achieved wound closure faster than those with a Sinbad score of 2 or 3. Those who did not achieve wound closure achieved a relative wound area reduction.”

The primary study outcome was wound closure rate by week 20, which was defined as the wound covered by 100% epithelialisation and no exudate. Secondary outcomes were: time to reach wound closure, relative wound area reduction at week 20; change in pain and patients’ quality of life from the initial visit to the final assessment, and occurrence of wound infection or of any adverse event throughout the study period.

Results The study included 23 patients with noninfected DFU with an average age of 65 years (range 35-85). The majority of patients were male and had type 2 diabetes. 96% had peripheral neuropathy, 43% PAD, 30% reduced mobility, and 26% history of amputation. There was an overall impairment in the patients’ HRQoL at baseline. Patients with reduced mobility, women and older patients (75 years old) had on average a lower EQ-VAS score and, therefore, poorer HRQoL than the others.

Sharp debridement was performed in all patients at each visit in order to remove callus and/ or wound debris. The contact layer was used to treat wounds covered by 30% or less of sloughy tissue, most often with low level of exudate, while the polyabsorbent dressing was selected to treat wounds covered by 50% or more of sloughy tissue, with low to high level of exudate. All wounds were then covered by an absorbent secondary dressing. During the course of the study, the dressings were changed once or twice a week. During the course of the study, 61% had an offloading device reported at all documented visits, seven patients (30%) were wearing their offloading device at all visits, except one or two (at presentation or at the final visit before healing or withdrawal), and poor adherence to offloading was reporting in two patients (9%), one being in a wheelchair.

In the study, 70% of patients achieved wound

34

Wound Masterclass - Vol 2 - December 2023

closure by the end of the 20-week period and 81% of these had occurred by the sixth week of treatment.

The 3 latest wound closures appear to have been affected by episodes of wound infection, suspected wound infection, and a large wound area at initial visit. The highest wound closure rate was patients without PAD (85% at 20 weeks), but 50% patients with PAD achieved closure by 20 weeks. Those with a Sinbad score of 1 achieved wound closure faster than those with a Sinbad score of 2 or 3. Those who did Table 2: SINBAD Score Table (from NFDA*) Category

Definition

SINBAD Score

Ischaemia

Pedal blood flow intact: at least one pulse palpable Clinical evidence of reduced pedal blood flow

0 1

Bacterial Infection

None Present

0 1

Depth

Ulcer confined to skin and subcutaneous tissue Ulcer reaching muscle, tendon, or deeper

0 1

not achieve wound closure achieved a relative wound area reduction.

Five patients reported wound infections and these symptoms were assessed as localised infection which were associated with sudden wound deterioration or enlargement, and/ or periwound erythema, but none was associated with any pain. When infections was present, the dressing was temporarily changed to an antimicrobial, and then the UrgoStart range was recommended when infection cleared.

Four patients reported positive pain scores over the duration of the study. The overall HRQoL of patients improved over the course

Optimising Healing in Diabetic Foot Ulcers: What is the Role of TLC-NOSF Dressings?

“Dialogue with the patient is also essential in the management of DFU. The severity of the condition should be explained to patients, their discomfort and pain assessed and managed, and their expectations discussed.”

of the study with a mean EQ-VAS score of 60.2 at baseline to 70.0 at the final visit (10 point difference on a 0-100 scale). The greatest gains in HRQoL scores were in those whose wounds healed by week 20 and who had the lowest score at baseline.

Discussion This study demonstrated that utilising UrgoStart dressings as initial local therapy per standard of care guidelines significantly benefited diabetic foot ulcer (DFU) healing. Aligning with National Diabetic Foot Care Audit recommendations, early specialist referral improves 3-month outcomes including ulcer-free survival, major amputation rates, hospitalization frequency, and inpatient stays. To facilitate prompt assessment, podiatrists serve an indispensable gatekeeping role in ensuring those with DFUs receive timely and appropriate treatment.

While first line instigation of standard of care is vital, priority rests with expeditious diagnosis and care aligned with current evidenced-based protocols. Early UrgoStart application facilitates the optimisation of healing trajectories. By promptly focusing on agreed standards of care, patients benefit from coordinated treatment plans balancing established best practices with emerging technologies shown to accelerate closure in DFUs. The earlier UrgoStart dressings are used the greater the benefits for the patient are realised compared with other neutral dressings, in terms of closure rate, healing time or cost saving.9,11-12 Evidence already exists to support the recommendation to use UrgoStart dressings in the standard of care to treat patients with DFU without peripheral arterial disease (PAD), and the 70% would closure rate and 24 days median time to heal in this study provides further evidence to support this recommendation, and is consistent with previous evidence.6,13-5 In this study, in common with previous research,

the best outcomes were achieved in those with less severe DFUs, but those with more severe wounds (higher Sinbad scores, PAD and large area at baseline) still achieved substantial healing outcomes. 43% of patients in this study had PAD which is challenging, increasing the risk of rapid deterioration and limiting the availability of antibiotics at the site of infection.

As diabetic foot infection is the most frequent diabetic complication requiring hospitalisation and is the most common precipitating event leading to lower extremity amputation in at risk of infection, rapid closure of the wounds, early diagnosis of wound infection and timely initiation of appropriate treatment can be limbsaving.

Debridement is another key element of standard of care in the management of DFU; in this study, wound debridement was performed in all patients at each visit, in order to remove callus that contributes to pressure, free the wound edge and remove slough and nonviable, necrotic tissue that can delay the healing process and facilitate infection. After removal of the sloughy tissue, which may reappear during the healing process, the UrgoStart Plus polyabsorbant dressing is beneficial in continuously cleaning the wound of slough as it contains polyabsorbent fibres and therefore maintains a suitable environment for healing the granulation phase and until healing. As maceration can also affect the migration of the epithelialised cells from the wound edge, it appears to be important to appropriately choose a primary dressing adapted to the characteristics of each wound, in close contact with the wound bed, and, when necessary, to use a secondary dressing to support the exudate management.

Dialogue with the patient is also essential in the management of DFU. The severity of the condition should be explained to patients, their discomfort and pain assessed and managed, and their expectations discussed. The closure of the wound requires several weeks to months,

Wound Masterclass - Vol 2 - December 2023

35

Optimising Healing in Diabetic Foot Ulcers: What is the Role of TLC-NOSF Dressings?

“It is clearly evident that early intervention with UrgoStart dressings can ensure faster healing in patients with DFU and improve quality of life. This study should give confidence to clinicians that they can implement evidence based practice effectively within their own clinical area.”

and it is important that the patients adhere to their treatment, including the use of off loading devices. This study used an alternative off loading method for the majority of patients which was routinely available (felt padding) compared with what is considered gold standard practice e.g total contact casting which was unavailable locally. However this did not affect the positive clinical outcomes. In this study, all the patients were provided offloading devices, although of different types, in order to take into account their needs and daily constraints, and facilitate their adherence to the offloading therapy.

Conclusion This small study in real life prompted the local specialist podiatry team to evaluate their current practice and the service they delivered to patients. The outcomes of this evaluation reflects the results of previous published clinical research and supports the recommendation from NICE. It is clearly evident that early intervention with UrgoStart dressings can ensure faster healing in patients with DFU and improve quality of life. This study should give confidence to clinicians that they can implement evidence based practice effectively within their own clinical area.

36

Wound Masterclass - Vol 2 - December 2023

References 1. Kerr M (2017) Improving Foot Care for People with Diabetes and Saving Money An Economic Study in England. Diabetes UK. Available at: http://bit.ly/2sXYHFp (accessed 22.05.2017) 2. Goodeve M, Saunders L, Grothier L (2022) Service evaluation: the benefts of TLCNOSF dressings on patients with diabetic foot ulcers. The Diabetic Foot Journal Harrogate: 44–54 3. Kerr M, Barron E, Chadwick P et al (2019) The cost of diabetic foot ulcers and amputations to the National Health Service in England. Diabet Med 36(8): 995–1002 4. Ismail K, Winkley K, Stahl D et al (2007) A cohort study of people with diabetes and their frst foot ulcer: the role of depression on mortality. Diabetes Care 30(6): 1473–9 5. Reinboldt-Jockenhöfer F, Babadagi Z, Hoppe HD, et al (2021) Association of wound genesis on varying aspects of health-related quality of life in patients with different types of chronic wounds: Results of a cross-sectional multicentre study. Int Wound J 18(4): 432–439 6. NICE (2019) Diabetic Foot Problems: Prevention and Management. NICE Guideline [NG19]. London: NICE. Available at: https://www. nice.org.uk/guidance/ng19 (accessed 25.10.2022) 7. Schaper NC, van Netten JJ, Apelqvist J et al (2020) Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update). Diabetes Metab Res Rev 36(Suppl 1): e3266. doi: 10.1002/dmrr.3266. PMID: 32176447.

8. NICE (2019). UrgoStart for Treating Diabetic Foot Ulcers and Leg Ulcers. Medical Technologies Guidance [MTG42]. London: NICE. Available at: https://www.nice.org.uk/ guidance/mtg42 (accessed 25.10.2022) 9. Lázaro JL, Izzo V, Meaume S et al (2016) Elevated levels of matrixmetalloproteinases and chronic wound healing: an updated review of clinical evidence. J Wound Care 25(5): 277–87 10. Jeffcoate J, Gooday C, Harrington A et al (2020) The National Diabetes Foot Care Audit of England and Wales: achievements and challenges. The Diabetic Foot Journal 23(1): 70–3 11. Lobmann R, Grünerbel A, Lawall H et al (2020) Impact of wound duration on diabetic foot ulcer healing: evaluation of a new sucrose octasulfate wound dressing. J Wound Care 29(10): 543–51 12. Maunoury F, Oury A, Fortin S et al (2021) Cost-effectiveness of TLC-NOSF dressings versus neutral dressings for the treatment of diabetic foot ulcers in France. PLoS One 16(1): e0245652. doi: 10.1371/journal.pone.0245652 13. Meloni M, Bouillet B, Ahluwalia R et al (2021) Fast-track pathway for diabetic foot ulceration during COVID-19 crisis: A document from International Diabetic Foot Care Group and D-Foot International. Diabetes Metab Res Rev 37(3): e3396. doi: 10.1002/dmrr.3396 14. Meloni M, Izzo V, Manu C et al (2019) Fast-track pathway: an easyto-use tool to reduce delayed referral and amputations in diabetic patients with foot ulceration. The Diabetic Foot Journal 22(2): 38–47 15. Tickle J (2021) NICE guidance in real life: Implementation of an evidence-based care pathway within a new wound healing 16. Goodeve M, Saunders L, Grothier L (2022), Service evaluation: the benefits of TLC-NOSF dressings on patients with diabetic foot ulcers. The Diabetic Foot Journal 25(4): 1-11

woundmasterclass.com

Introducing Wound Masterclass Video

woundmasterclass.com/Video

A Versatile Framework to Quickly Implement Wound Care-Specific, RoleBased Competency Programs Editorial Summary Establishing competency is a critical component of evidence-based wound care. However, developing comprehensive competency programs for our specialized field can be an arduous undertaking. A streamlined framework provides a versatile solution that allows clinicians to quickly implement targeted wound care competency programs based on staff roles.

The framework categorizes competencies into domains, classes, and subclasses, enabling organizations to identify exactly which skills are relevant for different positions. It incorporates recommendations from guiding bodies and allows competencies to be consistently updated as the field evolves.

Leveraging this framework, clinicians can work with team members to rapidly develop role-based competency programs. Gap analysis tools can further enhance efficiency. With competency checkpoints tied directly to patient care initiatives, organizations can readily demonstrate the impact of their education programs.

This modular, wound-specific competency framework allows clinicians to swiftly establish comprehensive yet focused competency initiatives for all wound care staff. Doing so elevates patient care through evidence-based practice while meeting regulatory requirements.

Introduction

S

taffing shortages have been a top patient safety concern.1 The need to quickly onboard new clinicians and ensure competent performance is compounded by the lack of a standardized approach to education/ training in wound care.2,3 It has been shown that organizations with competency programs have 40% lower turnover and 87% greater ability to hire the best people.4 However, consistently ensuring clinicians’ competency in wound care is challenging, given time/ resource constraints.

Objective To address these needs, we aimed to create a framework to quickly implement role-specific, wound care competency programs.

Method Dr Elaine H. Song

Ms Catherine T. Milne

Ms Tiffany Hamm

Co-Founder and Chief Executive Officer of WoundReference, Inc.

Advanced Practice Wound, Ostomy Continence Nurse, Connecticut Clinical Nursing Associates

Vice President, Global Research Development at The Henry M. Jackson Foundation for the Advancement of Military Medicine

Walnut Creek CA, United States

Bristol CT, United States

Rockville MD, United States

The method used is demonstrated by Figure 1:

Figure 1: Managers/clinicians’ needs, and role-based competency areas in wound care were mapped

Ms Nataliya Lebedinskaya

Ms Janis Prado

Mr Jeff Mize

RN, CWOCN, Kaiser Foundation Health Plan

CWOCN at Kaiser Permanente

Principal Partner at Midwest Hyperbaric LLC Co-Founder at Wound Reference Inc: Chief Clinical Officer & Business Development Officer

Concord CA, United States

Oakley CA, United States

Overland Park KS, United States

38

Wound Masterclass - Vol 2 - December 2023

Using the Design Thinking methodology,5 the solution* was created as a module within a clinical/ reimbursement decision support web-application for wound care/ hyperbaric clinicians

Role-based competency templates/training modules featuring evidencebased content, continuing education credits, and skills were built

Playbook for customization of the competency program was created

Framework was implemented in several organizations

© Copyright. Wound Masterclass. 2023

A Versatile Framework to Quickly Implement Wound Care-Specific, Role-Based Competency Programs

"The need to quickly onboard new clinicians and ensure competent performance is compounded by the lack of a standardized approach to education/training in wound care."

Results The framework is a digital solution that enables organizations to quickly implement/manage/document wound carespecific, role-based competencies.

Use cases include ongoing competencies for:

Acute Care Inpatient Nurses

Certified Wound Care Specialists

HBOT Professional Certification

To achieve quality goals, a hospital implemented customized pressure ulcer/injury prevention competencies for 330 nurses, cutting down educational program development time by 80%.

To complement their organization’s generic competencies and ensure their own competencies addressed their job duties/ responsibilities, specialists implemented wound-care specific competencies, reinforcing regulatory compliance.

To address lack of local qualified supervisor, candidate completed a Preceptorship Module utilizing an in-person/ remote approach and met preceptorship requirements to become a Certified Hyperbaric Technologist.

Conclusion

accreditation and regulatory requirements.

A framework to quickly deploy wound carespecific, role-based competency programs and meet continuing education/ certification/ compliance requirements was successfully developed/implemented. Its versatility may help organizations address staffing turnover by decreasing onboarding time, and increasing talent retention.

Most importantly, wound care competency programs centered on the needs of the patient enable us to provide compassionate, effective treatment to those suffering with wounds. They allow us to serve as collaborative partners focused on activating patients’ innate healing capacities.

By investing in the professional development of our wound care workforce through efficient and adaptable competency frameworks, we can spread the transformational power of growth, knowledge, and purposeful skills.

Implementing targeted wound care competency programs utilizing efficient frameworks provides multiplicative benefits across the breadth of our field. For individual clinicians, clearly defined competency standards reinforced through continuing education elevate the care we provide by keeping our knowledge and skills aligned with current best practices. For wound care centers and organizations, structured competency programs allow them to consistently deliver high-quality, evidence-based care that leads to improved patient outcomes.

Standardized programs also facilitate meeting

© Copyright. Wound Masterclass. 2023

References 1. ECRI. ECRI Reports Staffing Shortages and Clinician Mental Health are Top Threats to Patient Safety [Internet]. ECRI. 2022. Available from: https://www.ecri.org/press/ecri-reports-staffing-shortages-and-clinician-mental-health-are-topthreats 2. Williams EM, Deering S. Achieving competency in wound care: an innovative training module using the long-term care setting. Int Wound J. 2016 Oct;13(5):829–32.

3. Corriveau G, Couturier Y, Camden C. Developing competencies of nurses in wound care: the impact of a new service delivery model including teleassistance. J Contin Educ Nurs. 2020 Dec 1;51(12):547–55.

4. Garr S. Integrated Talent Management: A Roadmap for Success. Research Bulletin. 2012 Oct 19; 5. Ferreira FK, Song EH, Gomes H, Garcia EB, Ferreira LM. New mindset in scientific method in the health field: Design Thinking. Clinics. 2015 Dec 10;70(12):770–2.

6. Mize J, Hamm T. Quality of Care Requires Ongoing Competency Evaluations [Internet].

Woundreference.com.

2021. Available from: https://woundreference.com/blog?id=competency-assessments 7. The Joint Commission. About Our Standards | The Joint Commission [Internet]. 2021 [cited 2021 Jul 15].

Available from: https://www.jointcommission.org/standards/about-our-standards/

Wound Masterclass - Vol 2 - December 2023

39

How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide Editorial Summary Expanding upon the well-established TIME wound bed preparation protocol, M.O.I.S.T., an enhanced educational model designed by Wund-DACH researchers empowers healthcare practitioners to make well-informed and balanced decisions in the topical treatment of chronic wounds. Serving as a reference tool, the model advocates for a systematic and harmonized approach to wound care, thereby bolstering the practitioners' confidence in their treatment choices. Comprising 5 essential factors (Moisture, Oxygen, Infection, Support, and Tissue), the model offers a comprehensive framework that allows practitioners to adapt to the individual patient's requirements, elevating wound care practices to new levels of effectiveness and patient-centered care.

Introduction

W

ound care is a complex therapy area, with many variables impacting on the process of wound healing.

Often, patients present with multiple co-morbidities that can directly or indirectly affect wound healing.

Chronic wounds are, by their nature, wounds which take a longer time to heal. These include diabetic foot ulcers (DFUs), pressure ulcers/injuries (PI/Us), leg ulcers of different etiologies, and burns. These wounds are open areas or lesions which may present with significant tissue loss and contain a range of tissue types, spanning from healthy appearing granulation tissue to necrotic tissue and slough. Additionally these wounds frequently produce excessive levels of exudate which can negatively affect the wound and the surrounding skin. Chronic wounds can also be painful, malodorous, debilitating, and are often responsible for directly affecting the quality of life of the patient. This is not only a burden for the patient, but also for their families and carers.

Mr John Timmons International Medical Director, Mölnlycke Glasgow, United Kingdom

The financial burden of wounds within many health care systems may go relatively unrecognised due to the complex nature of the problem, lack of a unified approach, and the associated comorbidities.1

Assoc Prof Matthew Malone

Prof Dr Joachim Dissemond

Principle Scientist, R&D Bioactives and Wound Biology & Conjoint A. Professor Infectious Diseases and Microbiology, School of Medicine, Western Sydney University

Clinic for Dermatology, University Hospital Essen Essen, Germany

Macclesfield, United Kingdom

40

Wound Masterclass - Vol 2 - December 2023

A leading health economist in the United Kingdom has managed to successfully model the true financial cost of wound care in the National Health Service (NHS) and has found that the cost of wound care continues to grow despite advances in wound care knowledge and available technology. Some would argue that this technology has not yet made a significant impact on the delivery of care.

In one of the latest of these studies, Guest et al. (2017) suggest that wound care is often within a non-specialist environment and that this can in some cases lead to extended healing times with care episodes not being optimized. There is also significant pressure in many markets related to the cost of wound dressings despite little proof that the price of dressings is the root cause of care expense. In fact, Guest et al. have calculated that the cost of wound dressings is

© Copyright. Wound Masterclass. 2023

How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide Figure 1: HEIDI

MOIST

Outcome measures

History, Examination, Investigation, Diagnosis and Implementation

Moisture Oxygen Infection Support Tissue

Patient reported PROMS Clinical outcomes Economic outcomes

Holistic

Contents

Social or Environmental Patient experience

Using M.O.I.S.T. concept to enhance wound care and improve healing outcomes

only 6% of the cost of wound care. Most wound care costs incurred are associated with the costs of time for the clinician, clinic visits, and overheads for the facility where the patient is being treated.2 Professor Joachim Dissemond, Dermatology and Venerology Consultant with the additional discipline of Allergology, has practised at the Dermatology Clinic, Essen University Hospital, since 1999, initially as an Assistant Physician and then as a Senior Physician since 2003. A Wound Outpatient Clinic was set up at Essen University Hospital on Professor Dissemond’s initiative. The Dermatology Clinic is nowadays recognized as an interdisciplinary wound center.

Common Wound Etiologies Where M.O.I.S.T. May Be Applicable Chronic wounds can have many different causes. They are often characterised by their extended healing times, presence of sloughy tissue, excessive bioburden, and high levels of exudate.3 Coupled with underlying disease processes such as in the case of foot ulcers in diabetes, leg ulcers in patients with chronic venous insufficiency, and pressure ulcers in patients with restricted mobility, there are often many facets to the non-healing wound.

Wound chronicity can be characterized in different ways. The cause of chronicity may be time driven, meaning the longer a wound is open, the environment will change. Exposure to

bacteria in and around the wound will increase the bioburden and promote the development of bacterial biofilm and promotion of a persistently inflamed state. This hostile environment will lead to an increase in matrix and bacterial proteases which lead to off target destruction of host proteins, cellular senescence, and delayed healing. One may also think of a chronic wound as one that is found on a chronic patient, with comorbid conditions which may be the source of the wound (e.g., venous and/ or arterial insufficiency, diabetes) or a strong contributing factor (e.g., immobility, renal or pulmonary disease, cancer, autoimmune diseases) or drugs that can slow healing, in addition to chemotherapeutic agents, such as cytotoxic antineoplastic and immunosuppressive agents; corticosteroids, nonsteroidal anti-inflamatory drugs (NSAIDs), anticoagulants mTOR inhibitors (rapamycin), and hydroxyurea or tyrosine kinase inhibitors such as imatinib.

Therefore, it is not only important to address the immediate issues on the wound bed itself but also the underlying pathology which contributes to wound chronicity.

Why Adopt M.O.I.S.T. ?

In the absence of a consistent methodology, there have been many attempts to simplify approaches to the non-healing wound in order to make the assessment and management easier to understand and implement. One of the more successful of these was the TIME concept.4 The TIME concept was created by a group of expert clinicians to summarize the main steps of wound bed preparation. In short, the TIME acronym looked at T for tissue management, I for infection or inflammation, M for moisture management, and E for wound edge.

In 2016, a group of clinicians brought together

by WundDACH, the umbrella organization of German speaking wound healing societies, discussed the need to further develop the TIME concept to include some other aspects that should be considered in wound care today.5 This alternative approach appeared necessary because, after 15 years, new therapeutic options have emerged that could not be represented in the TIME concept, which focused primarily on wound bed preparation.

The acronym for this new approach is known as M.O.I.S.T. The letters in this acronym stand for

Wound Masterclass - Vol 2 - December 2023

41

How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide

“A good nutritional status is also an essential part of the care of patients with wounds in order to promote healing, and the management of pain should also be considered in the patients’ care.”

Moisture balance, Oxygen balance, Infection control, Supporting therapies, and Tissue management.5 This new acronym was not designed to be used in order but rather an aide memoire for the clinician who manages patients with chronic wounds.

Figure 2: How M.O.I.S.T. should be included in the overall patient assessment.

Supporting Therapies

Local Wound Treatment

Patient Assessment and the Use of M.O.I.S.T. As a Clinical Decision Aid In this article we will examine each of the letters of M.O.I.S.T. and how they may be used to support practice and aid in creating the appropriate treatment approach for the patient.

As with all wound care treatment and assessment systems, it is important to use a holistic framework in order to address all the needs of the patient. Therefore, the M.O.I.S.T. concept should be used in the context of the overall care of the patient. This will include full assessment of the patient, including all medical history and concurrent conditions, and a full assessment of the wound including duration, size and etiology; assuring that with the other supporting therapies, for example in patients with underlying venous and lymphatic disease, the patient will undergo a vascular evaluation, leading to appropriate compression therapy, as well as appropriate skin care. For patients with diabetes related foot ulcers, full assessment of neuropathy and potential ischemia will be necessary and off-loading devices will be used to support the overall approach to wound care.

A good nutritional status is also an essential part of the care of patients with wounds in order to promote healing, and the management of pain should also be considered in the patients’ care.

Figure 2 illustrates how M.O.I.S.T. should be included in the overall patient assessment.

M.

Patient & Wound

T.

O. I. S.

for wound healing, with early studies showing that achieving the correct moisture balance will promote healing.6 Wounds which are dry are likely to take a longer time to heal as a scab can form over the wound, and in turn the new cells have to burrow underneath in order to continue healing. In the meantime, the benefit has also been well proven scientifically, so that moist wound therapy is now recommended in most expert recommendations and guidelines.7,8 Exudate is an essential component of wound healing and provides an environment conducive to new tissue growth, enabling the presence of appropriate inflammatory mediators and growth factors into the wound bed and to act as a medium for migration of cells such as keratinocytes across the wound bed.9 Wound exudate also contains essential nutrients which are needed for cell metabolism. In addition to this, the presence of exudate supports the removal of dead tissue through autolysis.

M = Moisture Balance The creation of a moist wound environment has long been accepted as the gold standard

42

Wound Masterclass - Vol 2 - December 2023

In chronic wounds, the wound environment can be complicated with the presence of excessive exudate levels caused by a prolonged

How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide

“Many wound dressings now exist which can help to support the optimal moisture balance within the wound bed, some of which contain a silicon wound contact layer which not only promotes healing but facilitates pain reduction on dressing removal.”

inflammation. Chronic wound exudate has been shown to contain excessive levels of inflammatory mediators such as matrix metalloproteases (MMPs). When these exist in high amounts they can start to degrade the new extracellular matrix and the new tissue, which will prolong the inflammatory phase and therefore wound healing (Figure 3). It is also worth noting that most chronic wounds will also have an excessive bioburden, potentially as planktonic bacteria or bacteria encased in a biofilm, which in itself triggers the body's inflammatory response, leading to greater exudate production creating a cycle of continuous inflammation. Excessive moisture levels are not only detrimental to healing in the wound bed, but if not managed appropriately Figure 3: Pressure ulcer with poor exudate management. Note the damage to the surrounding skin caused by toxic contact dermatitis.

they can lead to maceration of the surrounding skin and ultimately, skin breakdown.9 When selecting a wound dressing, the goal should be achieving the optimal balance of moisture supporting a moist wound bed whilst absorbing and handling excessive exudate in order to promote wound healing and prevent maceration of the surrounding

skin.10 The dressing should also be able to adequately retain or move the exudate into a secondary dressing when external pressure is applied, in order to prevent the exudate from pooling on the wound bed and surrounding tissues, as in patients receiving compression therapy or those with foot ulcers who have a total contact cast in situ.

Many wound dressings now exist which can help to support the optimal moisture balance within the wound bed, some of which contain a silicon wound contact layer which not only promotes healing but facilitates pain reduction on dressing removal.

O = Oxygen Balance Oxygen is an essential component for many physiological processes and also has a direct impact on wound healing. Many problems with wound healing begin and end with an issue relating to oxygen levels in the wound and surrounding tissues. Oxygen is a vital requirement for every step in the wound healing process, including angiogenesis, revascularization, synthesis of connective tissue, and resistance to infection.11 Oxygen availability is a clear predictor for wound healing outcome; just 3% of wounds with an extremely low oxygen concentration heal, compared to 95% of wounds with a normal oxygen concentration.12 Hypoxia is often the case in lower limb wounds where arterial disease results in decreased blood supply and even in venous disease where there is reduced oxygen due to vascular inefficiency secondary to edema in the surrounding tissue.

Without oxygen, many cellular functions cannot be supported and in chronic wounds this can result in slow healing. Interventions that can help to improve tissue oxygenation include reperfusion/ revascularization surgery to help re-establish the arterial blood supply, which would then support oxygen transport to the wound site.

Wound Masterclass - Vol 2 - December 2023

43

How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide

“The majority of chronic wounds will contain bacteria in the form of planktonic bacteria, and also biofilm. The presence of high levels of bacteria, and often the compromised immunity of the patient or host, can lead to systemic infection.”

Compression therapy in the case of venous leg ulcers (VLUs) is an essential part of the treatment which helps to reduce edema in the limb, improving overall vascular efficacy by reducing distance diffusion of oxygen; over time wound healing should improve.13 More recently, products and therapies which supply oxygen directly or indirectly to the wound bed have been introduced, which facilitate the delivery of oxygen directly to the wound bed.14 This encourages wound healing by increasing the amount of available oxygen.

Arenberger et al. conducted a small randomized controlled trial (RCT) in 2011 of a haemoglobin spray on chronic ulcers of various types, which showed 93% healing at 6 months with haemoglobin spray compared with 7% healing without haemoglobin spray. There was a 93% success rate of healing (n = 42) with the haemoglobin spray group versus the control.15

I = Infection Control Infection is one of the biggest challenges for patients with wounds and for health care services. By their nature, chronic wounds are open skin defects which have been present for long periods of time.16 The wound bed is often complex, with many tissue types present, including slough, fibrin, and necrotic tissue.

The majority of chronic wounds will contain bacteria in the form of planktonic bacteria, and also biofilm. The presence of high levels of bacteria, and often the compromised immunity of the patient or host, can lead to systemic infection.16 Wounds are an ideal growth environment for bacteria due to the warm temperature, the presence of a food source (the wound tissue and sloughy tissue present), oxygen from the environment is readily available, and in many patients with co-morbidities immunity can be reduced, which makes them more susceptible to infection (Figure 4).

44

Wound Masterclass - Vol 2 - December 2023

Figure 4: Spreading infection and cellulitis as a result of VLU.

In recent years it has also been identified that open chronic wounds are likely to contain biofilm which cause chronic infections and delayed wound healing.17 Biofilms form when bacteria aggregate (meaning forming a clump of cells), attach to a surface, change the way they behave and produce a protective matrix. This contributes to enhanced tolerance to many therapeutics and the host immune system.

When assessing a wound that is infected, there are usually visible signs associated with infection and excessive bacterial proliferation.

These signs include but are not limited to: local redness, local heat, swelling/ edema, increasing pain, and loss of function. Other signs include excessive exudate and/ or a change in the type of exudate being produced; that is, the exudate may be thicker or more purulent in nature.16 The TILI score, a therapeutic index, designed by Dissemond et al., aims to help health professionals, in particular those not specialists in would care management, in the early identification of patients with locally infected wounds. It assesses 6 clinical criteria for local wound infection, including erythema of the surrounding skin; localised heat; edema, induration or swelling; spontaneous pain or pressure pain; stalled

How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide

“It is important to note that patients with diabetes or autoimmune disorders may not exhibit the traditional signs of infection, making detection difficult; with these patient groups it is therefore important to proceed with caution, and the use of antimicrobials and antibiotics may be necessary for longer periods of time.”

wound healing; and increase and/ or change in colour or smell of exudate. If the wound meets 5 of the criteria, then antimicrobial treatment can be commenced.18 Depending on the results of the clinical evaluation to be performed, this score could provide the basis for early intervention with a selective and time-limited use of localized wound therapy in patients with infected wounds.

When faced with a wound infection, it is important to act quickly to reduce the levels of bacteria and to prevent spread locally and systemically. This is best achieved by physical removal of non-viable or infected tissue such as debridement, and effective and repeated cleansing of the wound and periwound skin using a safe cleansing solution (for example, polihexanide or hypochlorous acid). Further extended antimicrobial activity can be achieved through the use of topical antimicrobial agents and dressings.

It is important to note that patients with diabetes or autoimmune disorders may not exhibit the traditional signs of infection, making detection difficult; with these patient groups it is therefore important to proceed with caution, and the use of antimicrobials and antibiotics may be necessary for longer periods of time.

S = Support the Wound Bed When it comes to the treatment of problematic wounds that do not heal as expected, there are various strategies available to help rebalance the environment inside the wound bed and facilitate the healing process. These strategies aim to address specific factors that may be impeding the healing progress and promote a more favorable environment for wound healing.

One approach is to control and bind excessive MMPs within the wound bed. MMPs are enzymes that play a crucial role in the breakdown of extracellular matrix components;

however, when their activity becomes excessive, it can lead to the degradation of healthy tissue and hinder wound healing.

By utilizing therapies or dressings that effectively inhibit or bind these MMPs, the excessive proteolytic activity can be controlled, allowing for a more balanced healing process.

Optimizing the pH conditions within the wound bed is another important aspect of promoting wound healing. An optimal pH range is necessary for the activation of enzymes involved in various stages of the healing process. Deviations from the normal pH range can impair enzyme activity and delay healing. Therefore, treatments that focus on maintaining the appropriate pH levels within the wound bed can help create an environment conducive to healing. There has not been a consensus of evidence supporting the optimal pH for wound healing.

Protecting growth factors is another strategy employed to facilitate wound healing. Growth factors are signaling molecules that regulate cellular activities and play a vital role in wound repair; however, they can be easily degraded or inactivated within the wound environment, which can hinder their effectiveness. Various techniques, such as the use of growth factor delivery systems or dressings that protect and release growth factors in a controlled manner, can help ensure their sustained presence and activity within the wound bed.

Controlling pro-inflammatory mediators is also crucial for successful wound healing. While inflammation is a natural part of the healing process, an excessive or prolonged inflammatory response can impede healing and contribute to chronic wound formation.

Therapies that target specific pro-inflammatory mediators or modulate the inflammatory cascade can help regulate the inflammatory response and create a more favorable environment for

Wound Masterclass - Vol 2 - December 2023

45

How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide

“A healthy wound bed is crucial for effective wound healing; in order to create an optimal environment for healing, it is necessary to clean and prepare the wound bed by removing any dead cells and tissue.”

healing.

Biosurgical debridement

In addition to these strategies, the use of collagen dressings can be beneficial for wound healing. Collagen, a major component of the extracellular matrix, provides structural support and promotes cell migration and proliferation.

Collagen dressings can help facilitate the formation of granulation tissue, aid in wound contraction, and provide a moist wound environment, which is conducive to healing.

This method involves the application of sterile maggots to the wound. Maggots secrete enzymes that selectively break down necrotic tissue, while leaving healthy tissue intact. This method has been used for centuries and has shown efficacy in promoting wound healing.

Overall, these therapeutic and treatment choices, such as controlling MMPs, optimizing pH conditions, protecting growth factors, controlling pro-inflammatory mediators, and utilizing collagen dressings, work together to rebalance the wound environment and promote the healing process. By addressing specific factors that may be inhibiting healing, these strategies can help get the healing of problematic wounds back on track and improve overall patient outcomes.

T = Tissue Management A healthy wound bed is crucial for effective wound healing; in order to create an optimal environment for healing, it is necessary to clean and prepare the wound bed by removing any dead cells and tissue. This process, known as debridement, can be achieved through various methods depending on the nature and condition of the wound.

Autolytic debridement This method involves the use of moistureretentive dressings that promote the body’s natural enzymatic processes to break down and remove necrotic or non-viable tissue. By maintaining a moist environment, autolytic debridement allows the body’s own enzymes to selectively degrade the dead tissue, while preserving healthy tissue.

46

Wound Masterclass - Vol 2 - December 2023

Surgical debridement As the name suggests, this method involves the removal of necrotic or non-viable tissue through a surgical procedure. Sharp surgical debridement is often used in cases where extensive debridement is required, such as in deep wounds, or wounds with significant infection. It allows for precise removal of unhealthy tissue and enables a clean wound bed for subsequent healing.

Enzymatic debridement This method of debridement involves the use of topical enzymes that selectively break down necrotic tissue. These enzymes are applied to the wound bed and left for a specific duration, after which the wound is cleansed. Enzymatic debridement is particularly useful in wounds with thick or adherent necrotic tissue.

Mechanical debridement These methods involve physically removing necrotic tissue through techniques such as wetto-dry dressings, wound irrigation, or the use of specialized instruments. Wet-to-dry dressings involve applying a moist dressing to the wound, which is allowed to dry and adhere to the necrotic tissue; upon removal, the dressing lifts away the dead tissue. Wound irrigation utilizes a gentle stream of fluid to flush away debris and necrotic tissue. Specialized instruments, such as curettes or forceps, may be used to mechanically remove non-viable tissue.

How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide In addition to debridement, certain treatment options can enhance its effects and promote wound healing. Negative pressure wound therapy (NPWT) involves the application of a vacuum system to the wound bed, which helps remove excess fluid, stimulate blood flow, and promote granulation tissue formation. Electrical stimulation and ultrasound therapy are physical therapies that can also enhance debridement by promoting cell growth, increasing blood flow, and reducing inflammation in the wound bed.

with eschar, is normally black in colour, is dry and leathery in appearance, and can be difficult to remove. This tissue will be a physical impediment to healing so must be removed to allow wound healing to take place. The quickest way to achieve this would be sharp debridement, however, this may not be suitable for all patients. Some autolytic gel products can be used to help soften the necrosis, but this may take significant time (Figure 5a).

Sloughy Tissue

Overall, a combination of cleansing the wound bed with appropriate solutions, employing different debridement methods such as autolytic, biosurgical, surgical, enzymatic, or mechanical techniques, and utilizing adjunctive therapies like NPWT, electrical stimulation, or ultrasound can help prepare the wound bed for optimal healing and improve outcomes for patients.

In most chronic wounds, debridement focuses on specific targets depending on the stage of wound healing. These targets encompass various aspects, including necrosis, slough, eschar, impaired tissue, sources of inflammation, sources of infection, exudate, serocrusts, hyperkeratosis, pus, hematomas, foreign bodies, debris, bone fragments, and other types of bioburden or barriers to healing.

Effective debridement aims to remove these elements and promote a cleaner wound bed, allowing for improved healing and optimal wound management.

Types of Tissue Necrotic Tissue

This often looks yellow, grey and/ or white in appearance. This tissue consists of white blood cells, dead tissue, bacteria and debris.

This is also a physical barrier to wound healing and as stated above, can act as a reservoir for bacteria. As with necrotic tissue, slough should be removed with sharp debridement where possible, and gelling fibre products or hydrogels can be used in between debridement episodes to support autolytic debridement, depending on exudate levels (Figure 5b, 5c).

Granulation Tissue Granulation tissue is the name given to the new tissue which is forming in the wound bed, due to its granular or bumpy appearance. Normal, healthy granulation tissue should be red in colour, not dark or grey which could indicate infection. Granulation tissue is a good sign that the wound is progressing towards healing. This tissue needs to be protected and prevented from drying out. Products used should maintain optimal moisture balance and may include wound contact layers, foam dressings and if necessary gelling fibre products when exudate levels are high (Figure 5d).

Necrotic tissue is when the wound is covered

Figure 5a: This pressure ulcer in an elderly female is covered with hard eschar.

Figure 5b: The majority of this wound is covered with sloughy tissue, not also the exudate on the wound surface.

5a

5b

5c

Wound Masterclass - Vol 2 - December 2023

47

How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide

“Once the wound has been cleansed and debrided, there is a small window (<24 hours) during which biofilm can reform or may be more sensitive to antimicrobials; therefore, one strategy to help reduce or prevent biofilm reformation is to use topical antimicrobial products on the wound surface at this time.”

Epithelial Tissue Epithelial tissue is the tissue that grows over the top of the wound once granulation is complete.

This should be pink in colour and often is seen beginning to form at the wound edges and also on the wound surface where hair follicles may be present. These are often seen as ‘islands’ of epithelial tissue. As with granulation tissue, epithelial tissue should be protected from physical damage and from drying out, as this will allow the new cells to migrate across the wound surface. Dressings may include wound contact layers and silicone foam dressings.

Biofilm Most chronic wounds not responding to standard of care have been shown to contain biofilm.19 Biofilm is the term used when microorganisms demonstrate altered behaviours; growth, metabolism, virulence, communication, and production of a protective matrix. Biofilms may form with the same species of microorganisms or as complex polymicrobial communities, however the principle function of biofilm is to protect the microbes from attack by therapeutics and the host immune system.

Importantly, biofilms are not visible to the eye and the microorganisms are often spread heterogeneously within wound tissue; biofilms do not just form evenly over the surface of a wound, but may exist as small aggregates of cells deeper in wound tissue. Biofilms cause chronic infections as the host immune system struggles to clear them from the tissue, and many therapeutics do not work as efficiently.

Ultimately, the downstream effects of chronic infection are the continuous induction of host inflammatory mediators, which damages host tissue.20 The result is that wound healing can be stalled or slowed down and exudate levels may increase. Biofilms can re-form very quickly (within hours to days) and reach full maturity within 3 days. Most of the

48

Wound Masterclass - Vol 2 - December 2023

literature agrees that wounds with mature biofilm are much more tolerant to therapies, thus are harder to heal than those with young, less mature biofilms present.

The most effective way to remove biofilm is through physical removal, such as regular sharp and mechanical debridement. However, debridement alone does not remove all biofilm because clinicians cannot see where they are exactly located within a wound. Consensus guidelines therefore propose that following debridement there is value in utilizing cleansing agents (e.g., hypochlorous acid) and/ or the application of topical antimicrobial dressings to ‘mop up' or reduce any residual microorganisms in the wound. Once the wound has been cleansed and debrided, there is a small window (<24 hours) during which biofilm can reform or may be more sensitive to antimicrobials; therefore, one strategy to help reduce or prevent biofilm reformation is to use topical antimicrobial products on the wound surface at this time. More frequent debridement may also be needed in order to tip the scales of reducing the biofilm before it quickly reforms.

Using M.O.I.S.T. To Help Support Clinical Practice

72-year-old male •

1-week duration diabetes-related foot ulcer (DFU) with associated acute infection

•

Depression, Hypertension,Type 2 Diabetes Mellitus, Dyslipidaemia, and Peripheral Neuropathy

•

DFU extends from the plantar 4th metatarsal head to the dorsal 4th interdigital space

•

Measured 1.5 cm2 (area) with a depth ranging from 0 to 3 cm

How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide •

The DFU was interconnected from the plantar 4th metatarsal head to the dorsal 4th interdigital space of the left foot; it measured 1.5 cm2 (area) with a depth ranging from 0 to 3 cm

•

Tissue management: The wound bed was composed of 14% sloughy and 86% granulating tissue

•

Infection control: The ulcer was associated with a moderate skin and soft tissue infection with cellulitis requiring outpatient based intravenous antibiotic therapy for 2 weeks

•

Tissue management: Curettage sharp debridement of the wound bed was only required at the baseline and initial study assessment

•

Infection control: The wound was cleansed with Granudacyn® (wound irrigation solution containing hypochlorous acid, Mölnlycke, Gothenburg, Sweden) at all dressing changes until the final study assessment when normal saline was used

•

At baseline, the wound was dressed (primary dressing) with Exufiber® Ag+ (silver-containing gelling fibre dressing, Mölnlycke, Gothenburg, Sweden) and Mepilex® (secondary dressing) (foam dressing, Mölnlycke, Gothenburg, Sweden))

•

Moisture management: Exudate levels were moderate, viscous, and purulent in appearance

•

The peri-wound skin was macerated (Figure 6a)

•

After 27 days of treatment, only Mepilex® was required

•

The ulcer had previously been treated with Inadine® (povidone-iodine impregnated dressing. 3M™, Maplewood, MN, United States) and Allevyn® Foam (foam dressing, Smith & Nephew, London, United Kingdom)

•

Throughout the study, Mefix® (adhesive dressing, Mölnlycke, Gothenburg, Sweden) was used for dressing fixation, and a CAM walker was used for offloading

•

The patient experienced no pain prior to and during dressing removal, during wound irrigation, and upon application of the study dressings

Dressings were changed at each study assessment and in between these visits the patient changed the dressings every 3 days, as per clinician directions

•

Follow-up assessments: After 27 days of treatment, the wound area was almost healed (Figure 6c)

•

Tissue management: The composition of the wound bed tissue steadily improved over the study period, and at the final

•

Treatment Regime A detailed wound evaluation was completed at a baseline assessment and 2 further scheduled study visits over a period of 27 days (Figure 6b).

Figure 6a: Start of evaluation (day 1). A 2-month-old foot ulcer with moderate levels of purulent, viscous exudate.

The wound bed tissue was 14% sloughy and 86% granulating tissue. The peri-wound was macerated.

Figure 6b: After 16 days of treatment, exudation was low, viscous, and clear/serous in appearance. The wound bed tissue was 5% sloughy and 95% granulating.

Figure 6c: End of evaluation (day 27) At the final follow-up visit, the wound was almost healed. The wound bed was composed of 100% granulating tissue.

6a

6b

6c

Wound Masterclass - Vol 2 - December 2023

49

How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide study assessment was composed of 100% granulation tissue •

Infection control: All clinical signs of wound infection were resolved after 27 days of treatment

•

Moisture management: After 16 days of treatment, wound exudate levels were low and clear/ serous in appearance but remained viscous; at the final study assessment it was non-viscous

•

Throughout the study, the peri-wound skin was healthy. The patient remained painfree during all dressing change procedures throughout the study

as indicated by the classic signs of inflammation, warmth, and erythema.

Oral antibiotics were prescribed •

Moisture balance: Exudate levels were high; viscous and yellow/ green in appearance, with wound malodor. The peri-wound skin was hyperkeratotic. The wound had previously been cleansed using normal saline, and dressed with Inadine® (povidone-iodine impregnated dressing, 3M™, Maplewood, MN, United States) and Zetuvit® (absorbent dressing, Hartmann, Heidenheim, Germany)

•

The patient was pain-free prior to and during dressing removal, during wound irrigation, and upon application of the study dressings due to loss of protective sensation (peripheral neuropathy)

Clinical Outcome At the final evaluation, the wound had almost healed and was no longer probing to bone.

Treatment regime •

A detailed wound evaluation was completed at a baseline assessment and at 4 further scheduled study visits over a treatment period of 53 days

•

Tissue management: A mix of debridement methods were utilized. Sharp curettage of the ulcer bed with a ring curette (baseline, follow-up visits 1 - 3) and sharp debridement (follow-up visits 2 and 3) of the peri-wound were performed; at the final assessment debridement was not required (Figure 7)

52-year-old male •

50

Acutely infected diabetes-related foot ulcer (DFU), secondary to peripheral neuropathy and poor footwear

•

Ex-intravenous drug user, on Methadone program

•

Type I Diabetes Mellitus, Hypertension, and Ischaemic Heart Disease, Peripheral Arterial Disease and Peripheral Neuropathy

•

12 months prior to presentation, the patient had undergone amputation of the right fourth toe

•

The DFU, located on the plantar 1st metatarsal head on the left foot, measured 7.8 cm2 (area) with a depth ranging from 0 to 0.2 cm. The ulcer duration at presentation was 4 weeks

•

Tissue management: The wound bed was composed of 9% slough and 91% hypergranulating tissue (as per 3D wound imaging software)

•

Infection control: There were clinical signs of a mild skin and soft tissue infection

Wound Masterclass - Vol 2 - December 2023

Figure 7a: Start of evaluation (day 1). A 4-week-old diabetic foot ulcer with high levels of yellow/ green, viscous exudate. The peri-wound skin was hyperkeratotic and callus was visible.

Figure 7b: Treatment day 20. After 20 days of treatment, the wound area had reduced by 30.8% to 5.4 cm2, with an average depth of 0.1 cm.

Exudation had reduced to moderate.

Figure 7c: Treatment day 27. After 27 days of treatment, the wound area measured 3.5 cm2 (a 55.1% reduction) with no wound depth. The wound bed was composed of 99% granulating tissue and 1% slough.

7a

7b

7c

How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide

Figure 7d: Treatment day 42. Wound area measured 1.9 cm2, a 75.6% reduction from baseline. Wound exudate remained moderate but was clear/ serous and non-viscous in appearance.

Figure 7e: End of evaluation (day 53). At the final follow-up visit, the area of the wound had reduced by 83.3% to 1.3 cm2.

7d

treatment, only mild wound malodor remained. At the final assessment, the wound was free from clinical infection and on a healing trajectory •

Moisture management: After 20 days of treatment, the level of wound exudate decreased to a moderate amount. Over the next 22 days and until the end of the study, the exudate transformed into a non-viscous and clear/ serous appearance. At the final assessment, the exudation was minimal.

Throughout the study, the skin surrounding the wound remained healthy. Additionally, the patient did not experience any pain during dressing changes throughout the entire duration of the study

•

Clinical outcome: The primary management approach for this patient focused on source control. This involved debridement to physically eliminate infected tissues, along with the use of topical antimicrobial therapy as an additional measure to reduce overall bioburden. Adequate fluid management was necessary due to the high exudate level. At the final assessment, the wound showed significant improvement and was progressing towards healing, indicating successful achievement of source control

7e

•

•

•

At all dressing changes, the wound was cleansed with Granudacyn® (wound irrigation solution containing hypochlorous acid) Infection control: At baseline, the wound was dressed with Exufiber® Ag+ (silvercontaining gelling fibre dressing; primary dressing) and Mextra® Superabsorbent (superabsorbent; secondary dressing (Mölnlycke, Gothenburg, Sweden)). After 20 days, as wound exudation had reduced, the secondary dressing was replaced with Mepilex® Border Flex (foam dressing).

Throughout the study, Mefix® (adhesive dressing) was used for dressing fixation, 2-layer Tubigrip® E (elasticated tubular bandage, Mölnlycke, Gothenburg, Sweden) provided compression therapy and a CAM walker was used for offloading Dressings were changed at each study assessment and, in between these visits, the patient changed the dressings as per clinician request

•

Follow-up assessments: After 53 days of treatment, the wound area had reduced by 83.3% to 1.3 cm2, with no depth

•

Tissue management: The composition of the wound bed tissue gradually improved over the study period, and after 42 days of treatment, was composed of 100% granulation tissue

Conclusion M.O.I.S.T. offers clinicians a framework to help support them in making good clinical decisions when managing patients with wounds. The real benefits of M.O.I.S.T. are more easily explained when the model is used in clinical practice.

The case studies above illustrate the benefits of using a platform such as M.O.I.S.T. to help with the assessment and treatment of patients with chronic wounds. By providing a methodical walk through the patient journey, M.O.I.S.T. can be used to help identify problem areas and encourage clinicians to consider the main wound related issues, and combined with holistic patient assessment it can provide a useful platform for the promotion of wound healing.

References •

Infection control: The clinical signs of wound infection had resolved following 3 weeks of antibiotic therapy and local wound management. After 42 days of

1. Guest JF, Vowden K, Vowden P. The Health Economic Burden That Acute and Chronic Wounds Impose on an Average Clinical Commissioning group/health Board in the UK. Journal of Wound Care [Internet]. 2017 Jun 2;26(6):292–303. Available from: https://www. magonlinelibrary.com/doi/full/10.12968/jowc.2017.26.6.292 ‌2. Guest JF, Fuller GW, Vowden P. Cohort Study Evaluating the Burden of Wounds to the UK’s National Health Service in 2017/2018: Update from 2012/2013. BMJ Open [Internet]. 2020 Dec 22;10(12):e045253. Available from: https://bmjopen.bmj.com/content/10/12/e045253

Wound Masterclass - Vol 2 - December 2023

51

How To Build Solid Foundations to Support the Treatment and Management of Chronic Wounds: A Clinician's Guide 3. Brown A. The role of debridement in the healing process. PubMed. 2013 Dec 24;109(40):16–9.

4. Schultz GS , Barillo DJ , Mozingo D W et al. Wound bed preparation and a brief history of TIME. International Wound Journal. 2004 Apr;1(1):44–5.

5. Dissemond J, Assenheimer B, Engels P, et al. M.O.I.S.T. - a concept for the topical treatment of chronic wounds. J Dtsch Dermatol Ges. 2017;15(4):443-445.

6. Winter GD. Formation of the Scab and the Rate of Epithelization of Superficial Wounds in the Skin of the Young Domestic Pig. Nature [Internet]. 1962 Jan;193(4812):293–4. Available from: https://www.nature.com/articles/193293a0 7. Heyer K, Augustin M, Protz K, Herberger K, Spehr C, Rustenbach SJ. Effectiveness of Advanced versus Conventional Wound Dressings on Healing of Chronic Wounds: Systematic Review and Meta-Analysis. Dermatology. 2013;226(2):172–84.

8. Dissemond J, Augustin M, Eming SA, Goerge T, Horn T, Karrer S, et al. Modern wound care - practical aspects of non-interventional topical treatment of patients with chronic wounds. JDDG: Journal der Deutschen Dermatologischen Gesellschaft. 2014 May 12;12(7):541–54.

9. Wound exudate and the role of dressings: a WUWHS consensus document - Wounds International [Internet]. 2007.

Available from: https://woundsinternational.com/consensus-documents/read-more-wound-exudate-and-role-dressingswuwhs-consensus-document-2/ 10. WUWHS Consensus Document - Wound Exudate, effective assessment and management - Wounds International [Internet]. 2019. Available from: https://woundsinternational.com/world-union-resources/wuwhs-consensus-documentwound-exudate-effective-assessment-and-management/ 11. Hu J, Guo S, Hu H, Sun J. Systematic review of the efficacy of topical haemoglobin therapy for wound healing.

International Wound Journal. 2020 May 19;17(5):1323–30.

12. Hauser CJ. Tissue Salvage by Mapping of Skin Surface Transcutaneous Oxygen Tension Index. Archives of Surgery. 1987 Oct 1;122(10):1128.

13. Addressing complexities in the management of venous leg ulcers - Wounds UK [Internet]. 2019. Available from: https:// wounds-uk.com/best-practice-statements/addressing-complexities-management-venous-leg-ulcers/

14. Gottrup F, Dissemond J, Baines C, Frykberg R, Jensen PØ, Kot J, et al. Use of Oxygen Therapies in Wound Healing.

Journal of Wound Care. 2017 May;26(Sup5):S1–43.

15. Arenberger P, Engels P, Arenbergerova M, et al. Clinical results of the application of a hemoglobin spray to promote healing of chronic wounds. GMS Krankenhhyg Interdiszip. 2011;6(1):Doc05.

16. Swanson T, Grothier L, Schultz G. Wound Infection Made Easy - Wounds International [Internet]. 2015. Available from: https://woundsinternational.com/made-easy/wound-infection-made-easy/ 17. Malone M, Schwarzer S, Radzieta M, Jeffries T, Walsh A, Dickson HG, et al. Effect on total microbial load and community composition with two vs six‐week topical Cadexomer Iodine for treating chronic biofilm infections in diabetic foot ulcers.

International Wound Journal. 2019 Sep 5;16(6):1477–86.

18. Dissemond J, Strohal R, Mastronicola D, Senneville E, Moisan C, Edward-Jones V, et al. Therapeutic Index for Local Infections score validity: a retrospective European analysis. Journal of Wound Care. 2020 Dec 2;29(12):726–34.

19. Bjarnsholt T, Eberlein T, Malone M, Schultz G. Management of wound biofilm Made Easy - Wounds International [Internet]. 2017. Available from: https://woundsinternational.com/made-easy/management-of-wound-biofilm-made-easy/ 20. Bjarnsholt T, Buhlin K, Dufrêne YF, Gomelsky M, Moroni A, Ramstedt M, et al. Biofilm formation - what we can learn from recent developments. Journal of Internal Medicine [Internet]. 2018 Jul 9 [cited 2019 Jul 17];284(4):332–45. Available from: https://onlinelibrary.wiley.com/doi/full/10.1111/joim.12782 ‌21. Trengove NJ, Bielefeldt-Ohmann H, Stacey MC. Mitogenic activity and cytokine levels in non-healing and healing chronic leg ulcers. Wound Repair and Regeneration. 2001 Dec 25;8(1):13–25.

22. Percival SL, McCarty S, Hunt JA, Woods EJ. The effects of pH on wound healing, biofilms, and antimicrobial efficacy.

Wound Repair Regen. 2014;22(2):174-186.

23. Strohal R, Dissemond J, Jordan O’Brien J, Piaggesi A, Rimdeika R, Young T, et al. EWMA Document: Debridement: An updated overview and clarification of the principle role of debridement. Journal of Wound Care [Internet]. 2013 Feb [cited 2019 Dec 20];22(Sup1):S1–49. Available from: https://ewma.org/fileadmin/user_upload/EWMA.org/Project_Portfolio/ EWMA_Documents/EWMA_Debridement_Document_JWCfinal.pdf 24. Bahr S, Mustafi N, Hättig P, et al. Clinical efficacy of a new monofilament fibre-containing wound debridement product.

J Wound Care. 2011;20(5):242-248.

woundmasterclass.com

Submit Your Research to Our Journal Case reports, randomized controlled trials, clinical reviews, audits, and research projects submissions@woundmasterclass.com

52

Wound Masterclass - Vol 2 - December 2023

Image licenced from Adobe Stock. Credit: Rawpixel.com

Masterclass GUIDES Introduction This guide introduces M.O.I.S.T. wound care integration, boosting practitioner confidence in independent decisions for treating chronic wounds. It enhances care through patient-centered planning, oxygen integration, and collagen synthesis for faster healing and reduced pain.

What is M.O.I.S.T.?

M.O.I.S.T. Wound Education Model Keywords ■ M.O.I.S.T. Concept ■ Chronic Wounds ■ Wound Education Model ■ Wound Care ■ Moisture Balance

■ Oxygen Balance ■ Infection Control ■ Support ■ Tissue Management

Figure 1:

■ The concept is intended to provide healthcare

professionals with guidance for systematic planning and education regarding the local therapy of patients with chronic wounds1

■ Acts as a reference tool that enables wound care

specialists to enhance treatment efficacy and confidence

■ Integrating supportive therapies like compression and off-loading, the M.O.I.S.T. approach ensures a holistic treatment approach

■ Flexibility in factor evaluation tailors treatment to

individual patient needs, ensuring personalized care and optimized outcomes

■ Empowers specialists to design personalized treatment

plans, enhancing healing and overall wound management

Wound Education Model

How Has It Been Developed?

■ In order to better structure the multitude of wound products, the M.O.I.S.T. concept was developed by a multidisciplinary expert group of WundDACH, the umbrella organization of German-speaking professional societies1

■ It expands upon the existing wound care best practices,

building upon the well-established TIME wound assessment protocol

■ The expanded framework adds oxygen and the crucial

restoration of optimal oxygen balance in wounds, enabling innovative therapies to recalibrate conditions for enhanced healing

Who Is It For? ■ Provides a balanced and structured approach for addressing diverse types of chronic wounds in various patients. It is intended for all wound care specialists and generalists responsible for patients with chronic wounds

■ Puts patients at the center of their care journey by guiding

clinicians and caregivers to consider the comprehensive spectrum of factors influencing their wound healing process

■ Incorporates current clinical best practices, offering healthcare practitioners a unified framework to enhance care consistency and optimize patient outcomes

■ Promotes evidence-based treatment protocols and facilitates

more effective product selections within the healthcare system

■ The successful therapy of chronic wounds is then based on

the causal treatment of the underlying, pathophysiological relevant diseases2

54

Wound Masterclass - Vol 2 - December 2023

Masterclass GUIDES

M.O.I.S.T. Wound Education Model

Moisture Balance: How can we help ensure that a wound isn’t too wet or too dry?

■ A wound’s inability to heal can result from either

excessive dryness or excessive moisture. Thus, it becomes imperative to achieve a balance of moisture within the wound for effective healing

■ There is a range of dressings which preserve moisture level or absorb excessive exudate to reach moisture balance

Treatment options include:

■ Wound gels to add moisture ■ Alginates, hydrofibers, foams and superabsorbers absorb exudate and other fluids

Oxygen Balance: How can we restore oxygen to a wound so it can heal?

■ Oxygen plays a pivotal role in the body’s metabolic

processes, including the intricate mechanisms of wound healing. Deficiency in oxygen can significantly impede the progress of numerous chronic wounds

■ Restoring oxygen to the correct level is a critical

Treatment options include:

■ Haemoglobin spray, hyperbaric or normobaric oxygenation

element to support all phases of healing

Infection Control: How can we manage the risk of infection in chronic wounds

■ Infection poses an ever-present and significant threat to chronic wounds, inducing pain, discomfort, and potential delays in healing that may necessitate hospital readmission

■ Continuous watchfulness aids in infection

prevention, and timely intervention can halt potential complications. Multi-resistant pathogens can be eliminated and local infections managed with topical antiseptics or antimicrobial dressings

Treatment options include:

■ Wound gels to add moisture ■ Alginates, hydrofibers, foams and superabsorbers absorb exudate and other fluids

Support: How can we support and stimulate healing in hard-to-heal wounds?

■ When problematic wounds are treated but do not heal as expected, strategies to rebalance the environment inside the wound bed can get healing back on track3

A range of therapeutic and treatment choices are available to stimulate healing:

■ Control and bind excessive MMPs, optimise pH

conditions, protect growth factors, control proinflammatory mediators, collagen dressings

Tissue Management: What are best practices in cleaning and preparing the wound bed?

■ Maintaining a healthy wound bed is crucial for

healing. This involves cleansing and preparing the area, removing dead cells and tissue through diverse debridement techniques

■ Specialised dressings or physical therapies like

negative pressure wound therapy (NPWT), electrical stimulation or ultrasound can enhance the effects of debridement

Treatment options include:

■ Cleanse the wound with normal saline (9%); Ringer’s solution; preserved solution

■ Debride the wound through autolytic, biosurgical, surgical, enzymatic and mechanical methods and therapies

Wound Masterclass - Vol 2 - December 2023

55

Masterclass GUIDES

M.O.I.S.T. Wound Education Model

What Is the Evidence?

M.O.I.S.T.’s efficacy, cost-effectiveness, and infection control have been validated through trials. They have gained significant popularity because of their ability to create an optimal environment for wound recovery.4 It accelerates recovery, reducing complications and costs. Early M.O.I.S.T. concept intervention prevents chronic wounds, leading to expedited healing, reduced pain, and potential savings. This technique enhances mobility, circulation, and protein efficacy, thereby minimizing the risk of infection. In turn, this bolsters patient satisfaction and enhances outcomes.

Efficacy ■ Moist wound healing stimulates fibroblasts to

synthesize collagen. Since collagen is crucial for new tissue formation and wound healing, this heightened production expedites the body’s creation of a framework for new tissue, thereby attracting the necessary healing cells

Pain ■ A moist wound environment reduces the possibility of infection

■ Moist wound healing environments are hypoxic.

This nature is generally unconducive to the growth of harmful infectious agents. Moreover, hypoxia promotes the formation of new blood vessels and improves tissue perfusion required for adequate healing6

■ Moist wound healing stimulates fibroblasts to

synthesize collagen, a pivotal component in new tissue formation and wound healing. This heightened collagen production accelerates the creation of a framework for new tissue, facilitating the attraction of essential healing cells

■ Preserves growth factors in wound fluid,

they are proteins which control key cellular activities during the tissue repair process. This preservation of growth factors on the wound bed within a moist environment expedites tissue repair, fostering accelerated healing

■ By promoting the growth and movement of new

cells and ensuring that proteins for closing the wound are efficient, causes reduced inflammation, promotes more even skin formation and therefore reduces scarring5

■ A good nutritional status is also an essential part of the care of patients with wounds in order to promote healing, and the management of pain should also be considered in the patients’ care

■ Therapies that target specific pro-inflammatory

mediators or modulate the inflammatory cascade can help regulate the inflammatory response and create a more favorable environment for healing

■ Many wound dressings now exist which can help

■ Controlling MMPs, optimizing pH conditions,

protecting growth factors, controlling proinflammatory mediators, and utilizing collagen dressings, work together to rebalance the wound environment and promote the healing process

■ By addressing specific factors that may be

inhibiting healing, these strategies can help get the healing of problematic wounds back on track and improve overall patient outcomes

to support the optimal moisture balance within the wound bed, some of which contain a silicon wound contact layer which not only promotes healing but facilitates pain reduction on dressing removal

Debridement ■ A healthy wound bed is crucial for effective wound

healing; in order to create an optimal environment for healing, it is necessary to clean and prepare the wound bed by removing any dead cells and tissue.

This process, known as debridement, can be achieved through various methods depending on the nature and condition of the wound

■ By promoting collagen synthesis and creating an

optimal wound healing environment, the M.O.I.S.T. concept wound education model can expedite the healing process. This results leads to shortened treatment periods and decreased associated costs

■ Fewer complications arise from establishing an

environment that minimizes infection risks and necessitates fewer dressing changes. By averting complications and employing suitable moistureretentive dressings, less frequent alteration is required. As a result, moist wound healing dressings showed a cost reduction, compared to traditional dressings7

■ The prevention of chronic wounds is achieved by

prioritizing early intervention and appropriate wound management techniques. Effectively treating wounds during their initial stages can help stave off the development of chronic wounds, which are more challenging and costly to address

■ Patient outcomes are enhanced through faster

healing and reduced pain. This translates to shorter hospital stays, lower readmission rates, and increased patient satisfaction, all contributing to potential cost savings

■ When faced with a wound infection, it is important

to act quickly to reduce the levels of bacteria and to prevent spread locally and systemically. This is best achieved by physical removal of non-viable or infected tissue such as debridement, and effective and repeated cleansing of the wound and periwound skin using a safe antiseptic cleansing solution (for example, polihexanide or hypochlorous acid)

56

Wound Masterclass - Vol 2 - December 2023

M.O.I.S.T. Wound Education Model

Masterclass GUIDES

Key Points

■ The M.O.I.S.T. concept stands for Moisture balance, Oxygen balance, Infection control, Support, and Tissue management ■ Serves as an actionable reference tool for wound care specialists ■ Reduces pain and stress, which enhances patient mobility, circulation, and overall healing ■ Prevents infections and fosters angiogenesis while inhibiting bacteria ■ Healing is accelerated through collagen synthesis, reducing treatment duration and costs ■ Chronic wounds are prevented through early intervention and proper management

References 1. Dissemond J, Assenheimer B, Gerber V, et al. Lokaltherapie chronischer Wunden: Das M.O.I.S.T. Konzept [M.O.I.S.T. concept for the local therapy of chronic wounds].

Dtsch Med Wochenschr. 2023;148(7):400-405. doi:10.1055/a-1987-4999 2. Dissemond J, Bültemann A, Gerber V, Jäger B, Kröger K, Münter C. Diagnosis and treatment of chronic wounds: current standards of Germany’s Initiative for Chronic Wounds e. V. J Wound Care. 2017;26(12):727-732. doi:10.12968/jowc.2017.26.12.727 3. M.O.I.S.T. educational platform | Mölnlycke | Mölnlycke Advantage [Internet]. www.molnlycke.com. Available from: https://www.molnlycke.com/education/wound-areas/ moist/ 4. Liang Z, Lai P, Zhang J, Lai Q, He L. Impact of moist wound dressing on wound healing time: A meta-analysis [published online ahead of print, 2023 Jul 19]. Int Wound J. 2023;10.1111/iwj.14319. doi:10.1111/iwj.14319 5. Wound Source. The Benefits of Moist Wound Healing [Internet]. WoundSource. 2016. Available from: https://www.woundsource.com/blog/benefits-moist-wound-healing 6. The Benefits of a Moist Wound Healing Environment [Internet]. 2023 [cited 2023 Aug 17]. Available from: https://www.thewoundpros.com/post/the-benefits-of-a-moist-wound-healing-environment#:~:text=Reduced%20Likelihood%20of%20Wound%20Infection,perfusion%20required%20for%20adequate%20healing.

7. Schmitz M, Eberlein T, Andriessen A. Wound treatment costs comparing a bio-cellulose dressing with moist wound healing dressings and conventional dressings. Wound Medicine. 2014;6:11–4. doi:10.1016/j.wndm.2014.07.002

Useful Links

Use your device to scan this QR code for more information about M.O.I.S.T.

Click here to visit the Mölnlycke® website

How to Cite this Article Masterclass Guide: M.O.I.S.T. Education Model. Wound Masterclass. Volume 2. No 6. September 2023.

SPONSORED BY

Wound Masterclass - Vol 2 - December 2023

57

Global Innovation in Wound Care Summit Series Part 2: Biofilm Masterclass Moderator Miss Negin Shamsian Consultant Plastic and Reconstructive Surgeon (Locum) London, United Kingdom

So, What is Biofilm?

Biofilm is defined as one of the oldest lifeforms on Earth and is something developed by bacterial organisms. It is only within the last 40 years that Biofilm has been given this name in Science and Medicine; and it is the natural and predominant

Introduction

way that bacteria live and thrive. Bacteria will attach

I

themselves to a surface, which can either be liquid or mmersive Interactive Event; Taking wound care

solid, and once they’re securely attached, they secrete

into a new dimension. Hosted by Dr N. Shamsian

a polymeric matrix around themselves – This is what

in partnership with Dr M. Sanders and Dr P Bowler.

we call Biofilm. Biofilm acts as a protective layer that

Bowler has an extensive history and career within

defends the bacterial organism from hostilities within the environment or hosted organism.

wound care development and research with over

Supported by

30 years of experience in microbiology, particularly

This Biofilm layer contains exopolysaccharides – high-

focused on infections. He has been involved in the

molecular-weight polymers that are composed of

development of wound dressings alongside various

sugar residues and are secreted by a microorganism

independent consultants. Sanders has worked for

into the surrounding environment – DNA and RNA.

a diagnostic wound care company that developed

Both DNA and RNA are almost identical, are used

diagnostics for bacterial status that was sold back into

to store genetic information, but they have differing

the wound-check business. After 16 years working

base pairs and can be found in various places of the

with the company, he joined a consulting firm where

cell, but mostly within the nucleus. Due to this nature

he expanded this experimental field by developing

and structure of the Biofilm, it is easy for them to

numerous products for wound care and targeted the

adapt by altering or changing their phenotype and

anti-inflammatory stages, and infection whilst also

genotype for survival. This presents a challenge in

maintaining an interest in the fields of cancer and

the microbiology world of Science and Medicine as

brain injury through studying neuroinflammatory

it means antibiotics are ineffective in the treatment

processes. He now works in partnership with the

of bacterial infections that include such complex

consulting firm ProDevLabs who are supporting the

structures.

event discussed today.

58

Wound Masterclass - Vol 2 - December 2023

© Copyright. Wound Masterclass. 2023

Global Innovation in Wound Care Summit Series Part 2: Biofilm Masterclass

“Biofilm is inextricably linked to chronic infections, leading to delayed healing and recurrence. This requires tailored treatment for wound care.”

Dr M. Sanders

Treatment: Antibiotics and Initial Stages

no mention of Biofilm; during this time, Science and Medicine were aware of the existence but unsure of

Antibiotics and antiseptics are mostly ineffective

the capabilities, adaptability and extensive nature of

against Biofilm due to this shifting nature and structure

the bacteria.

that Biofilm possess, meaning the inflammatory response within a wound is increased. At this stage,

At What Point Does the Wound Become Critical

it is integral and crucial that debridement and the

During This Colonisation?

washing of the wound is used as an intervention to discover the depth and nature of the inflammatory

When we consider the critical nature of a wound, it is

process.

important to consider the comorbidities and health of the patient overall. This staging of ‘critical’ will differ

How Does the Biofilm Trigger the Inflammatory

from patient to patient, and there is no set timeframe.

Response?

Essentially, this will be when the host is no longer able to control the microbial contamination, therefore

When the Biofilm hijacks the hosts skin/wound,

requiring

additional

and

interventive

microbial

neutrophils attempt to discover the parasite or

support to manage the wound and return control to

bacterial infection where they undergo an oxidated

the host.

burst. The Biofilm itself is tolerant to the immune cells and attracts them towards the bacteria where they

Bowler states that he would not use this term

spill enzymes into the surrounding environment that

in modern society and the world of Science and

damage the hosts tissue further, which is why we can

Medicine as it has been superseded by the Biofilm

almost consider Biofilm to be a parasitic infection.

Continuum. Bacteria initially starts as a planktonic cell

As this tissue devitalises, it provides more tissue

on the surface, mostly a wound, where they attach

for the Biofilm to consume and continue to spread.

themselves and adapt rapidly. As the Biofilm layer is

Elimination of the Biofilm at this stage becomes

produced, this is the continuum; the process by which

crucial to prevent further inflammatory response and

the wound becomes colonised.

infection spread, whether this is through physical intervention, antimicrobial or new strategies within

Randy Walker, a pioneer in the field of Science and

wound care.

Medicine, recently spoke about ‘When does a wound become chronic? Does this take 30 days or longer?’

Bowler very clearly agrees that all chronic wounds

The problem with this question is that Biofilm can

have a Biofilm element due to their nature being so

quicken the process, and a wound can easily turn

disruptive and the response to antibiotic treatment.

chronic within a matter of days. Walker acknowledges

As the antibiotics are ineffective and the persistence

this and takes the approach that; if there are warning

of chronic wounds prevails, there is clear evidence

signs there, effectively treat in the early stages.

that a Biofilm layer is preventing efficient healing.

This will minimise the chance of chronic wounds,

The impact of Biofilm on the healing stages is vast

inflammation and the need for further intervention

and includes, but it not limited to; delayed healing

through new strategies and emerging technologies.

response, chronic wounds, recurrent infections, delayed closure, and impaired blood vessel formation.

Challenges: What Do Professionals Face When Treating Biofilm?

Critical Colonisation is a term that was used for around 25 years and refers to the stage when

Some of the challenges that consultants and working

bacteria colonise a wound to cause further infection

professionals face when treating wounds, those

and increased challenge to treatment. When this

that have this Biofilm layer, is the microscopic and

term was first penned by professionals, there was

hidden nature of the Biofilm itself, the variable

© Copyright. Wound Masterclass. 2023

Wound Masterclass - Vol 2 - December 2023

59

Global Innovation in Wound Care Summit Series Part 2: Biofilm Masterclass

“We need a Multifactorial Blockade to healing.”

Dr N. Shamsian

composition of the bacteria, sampling techniques

For immunocompromised individuals, Pseudomonas

for definitive diagnosis, laboratory techniques to

Aerginosa is a major issue as it is multi-antibiotic

extract the DNA, dynamic nature of the wound, false-

resistant and this reduces the effectiveness of

negative results and the final clinical interpretation.

treatment so further treatment and combination

From the initial stage of seeing the wound, to the

therapies must be considered.

final stage of diagnoses there are clear barriers and challenges that need to be considered. There are also

New Treatment and Strategies

further factors to consider, like the comorbidities of patients, particularly those with Diabetes or Venous

Dr Bowler and Dr Christine Murphy, specialist from

insufficiency as this can cause further issues when

Ottawa, Canada, have penned the term Granulitisas

determining the nature of the wound; and whether

the induced hyperinflammatory process of Biofilm.

the wound does have a Biofilm component.

Although developing technologies are helping to identify the nature of the wound, it is crucial to

Accurate diagnosis is vital for effective treatment of

start effective treatment and reduce the risk of

the wound as we can guide our targeted antimicrobial

occurrence of Granulitis. This treatment can include

selection for patients, and it allows room for

Photodynamic Therapy, Quorom Sensing Inhibitors,

combination therapy where appropriate. Consultants

Biofilm Disputing Enzymes, Nanoparticle based

can be more informed of the optimal wound

approaches,

management and strategies to reduce the risk of

Systems, Electrochemical Treatments, Antibiofilm

recurrence, whilst optimising the resource utilisation

Surfaces and Coatings, Biofilm Imaging Techniques,

and improving the overall treatment outcome.

Combination Therapies and Vaccines.

Some examples of specific microorganisms include:

Bowler mentions that they have been developing a

Biofilm-responsive

Drug

Delivery

3-Dimensional printing method to copy Biofilm, or •

Staphylococcusaureus

a collagen substrate, to assess antibiofilm agents in

•

Pseudomonasaeruginosa

vitro. By implanting the genetically contained and

•

Escherichia coli

grown organisms, they have transplanted this onto

•

Streptococcus species

animals for experimentation and testing. These

•

Fungi

models prove vital for representing the stages

•

Viruses specifically

and demand of resistance that we see on humans’

•

Bacteriophages

wounds. These clinical models are invasive and

•

Protozoa such as acanthamoeba and naegleria

hard to remove, and professionals find themselves

species

using fine and sharp debridement as a method for removing and disrupting Biofilm, enhancing the

And some further examples of microorganisms that

importance of an imaging device to see the definitive

we know leave Biofilm in wounds include:

nature of a wound. By using this strategy, we can visualise the location of the Biofilm and target directly with treatment.

•

Staphylococcus aureus

•

Pseudomonas aeruginosa

•

Escherichia coli

•

Candida Albicans

•

Proteus Mirabilia’s

Using a Cellink 3D BioX Printer to print methacrylate

•

Enterococcus Faecalis

collagen

3-D Printed Biofilms

loaded

aeruginosaor

with

either

Staphylococcus

GFP-Pseudomonas aureus

and

then

photo-activated the collagen with lithium phenyl-2, 4, 6-trimethylbenzoyl phosphonate (LAP) dye and

60

Wound Masterclass - Vol 2 - December 2023

© Copyright. Wound Masterclass. 2023

Global Innovation in Wound Care Summit Series Part 2: Biofilm Masterclass

““Infection diagnostics are difficult in the US due to the diagnostic stages and determining the Biofilm infection.”

Dr M. Sanders

polymerised with a near UV-light source. An amber

Conclusion

syringe containing a suspension of 2mls of Lifelink 200 collagen and 250 jul of an overnight culture of

Sanders states that the two main aspects of Biofilm

each microbe was loaded into the printer in a dark

in relation to wound care is to; Prevent the formation

room to avoid premature curing of the collagen

at the initial stages; Disrupt and Destroy the Biofilm.

with ambient light. After printing all the layers of the

Enhanced treatment efficacy and a personalised

collagen-microbial disk, the UV light was utilised to

treatment approach are essential for reducing the

cure the 3D print.

risk of recurrence, prevention of chronic infection and the improvement of wound healing, which, results in

Following the printing, the Biofilm disks were exposed

patient quality of life and cost savings for Science and

to natural light for 30 minutes to allow for complete

Medicine.

curing and then incubated overnight at 37C. The disks were then incubated for another 24 hours in a proprietary Biofilm binding buffer and were either used immediately or stored in tryptic soy broth with 2% sucrose for lyophilisation followed by ambient storage at -80C for future use.

In these trials for 3-D printing, Bowler also states that he has found some antimicrobials are effective at reducing the exopolysaccharide matrix and others

See all Wound Masterclass MasterSeries on demand: bigmarker.com/wound-masterclass

are good for destroying Biolase. Primarily, these are ineffective once the Biofilm has occurred and that is the reason for no further development of new antibiotics within the laboratory for treatment of wounds.

© Copyright. Wound Masterclass. 2023

Wound Masterclass - Vol 2 - December 2023

61

Global Innovation in Wound Care Summit Series What Do I Need to Know About Skin Substitutes?

Moderator Miss Negin Shamsian Consultant Plastic and Reconstructive Surgeon (Locum) London, United Kingdom

requirements. Surgery and secondary healing is good, when a combined approach can occur, but the key question is when to use what.

Dr N. Shamsian precedes to ask, ‘What is the most common type of wound you see?’, to which Devine responds that it is mostly chronic wounds; venous

Introduction

ulcers, lower extremity wounds, and sometimes

D

surgery from previous cancer treatment. The use r N. Shamsian is joined by North American

of skin substitution is vital as it can prevent further

expert Dr J. Lantis (Professor and Chief in

arduous surgical management and gives the clinician

Surgery), Associate Professor M. Wagstaff

options for preservation and treatment.

(Head of Plastics and Reconstructive Unit, Australia) and Dr M. Devine from Arizona (Plastics and

“How has microsurgical transfer to skin substitutes

Reconstructive Surgeon).

changed over the last 2 decades?”

Global expert

Due to the variety of options available for skin substitution, there is a lesser need for surgical

Dr Michael N. Desvigne

transfer, but rather more additional scaffolding with

Board-Certified Plastic Surgeon, General Surgeon, Hyperbaric physician, Wound Care Clinician

skin substitutes and the advantage of synergistic

Scottsdale AZ, United States

of experience, or expertise, is within the field of

substitution. Devine explains that his primary area placental-type products.

Supported by

The Use of Aseptically Processed Placental Allograft

Processing the material matters as you can achieve

and Meshed Reticular Acellular Dermal Matrix in

the same sterility as terminally sterilized tissue

Soft Tissue Reconstruction

which preserves tissue structure, matrix proteins and signaling cues. This provides a safe, quality

62

Dr M. Devine hosts the next segment of wound

tissue that is most like native autograft (human skin).

management as a Plastics and Reconstructive

Terminal sterilization alters tissue properties of the

surgeon based in Arizona. Devine notes that there are

native tissue by denaturing the structure and matrix

a lot of options for skin substitutes, and it depends

proteins, with a compromised binding site for cell

on the goal and customized approach of the patients’

attachment and signaling functions.

Wound Masterclass - Vol 2 - December 2023

© Copyright. Wound Masterclass. 2023

Global Innovation in Wound Care Summit Series: What Do I Need to Know About Skin Substitutes?

“The meshed HR-ADM had properties that allowed for tissue integration and incorporation with the soft tissue deficits benefitting particularly from the processed placental allograft.”

aseptically processed allograft included proliferation, We must consider an algorithmic approach to

angiogenic, and antimicrobial properties that were

placental allografts.

useful for wound healing and surgical reconstruction.

The meshed HR-ADM had properties that allowed

•

Wound management; Cellular proliferation –

for tissue integration and incorporation with the

AmnioBand Membrane. Dermal replacement –

soft tissue deficits benefitting particularly from the

AlloPatch Pliable

processed placental allograft. The use of HR-ADM may aid in creating a scaffolding for tissue ingrowth,

•

•

Incisional management; Cellular proliferation –

later supporting flap transfer, as well as adequate soft

Salera mini membrane placental Allograft

tissue coverage.

Anticipating post-surgical complications; cellular

Global expert

proliferation – Salera mini membrane placental

Prof Marcus Wagstaff

Allograft. Dermal replacement and/or soft tissue

Plastic and Reconstructive Surgeon, Head of Unit of the Adult Burns Service at the Royal Adelaide Hospital (RAH)

scaffolding – SomaGen Meshed dermal matrix •

Optimizing

surgical

outcomes;

Adelaide, Australia

Cellular

proliferation – Salera mini membrane placental allograft. Dermal replacement and/or soft tissue scaffolding – SomaGen Meshed dermal matrix

NovoSorb BTM - Biodegradable Temporising Matrix

Some of the key benefits to Somagen is that it is the

In this next segment of wound management and

first of its kind (meshed reticular dermal allograft), is

skin substitution methods, we go to Prof M Wagstaff

ready to use that saves valuable operating theatre

(Associate and Desvigne Professor in Plastic Surgery,

time, pliable and conforms to anatomy, compatible

and the Head of Burns Unit Royal Adelaide Hospital,

with advanced wound care such as NPWT, it has

Australia). When BTM was being developed in 2011,

a versatile meshing ratio which allows clinicians

Wagstaff was part of the research team and overlooked

to address wounds on a much larger scale, and an

the first clinical trials with human patients, further

18-month shelf life at room temperature.

developing the products based on their findings and research. Synthetic skin substitutes include a variety

Case

Summary;

Multiple

pressure

ulcers.

66

of temporary and permanent examples, and the

y/o paraplegia secondary to transverse myelitis

ones we tend to think of are Bio-Brane (for epithelial

secondary to COVID. This patient developed multiple

coverage of superficial burns to prevent water loss),

pressure ulcers during prolonged hospitalization

and dermal substitutes that are a permanent implant

which progressed to the bone. The patient was

(BTM). Biodegradable Temporising Matrix is a 2mm

then admitted to hospital for acute infection and

bioabsorbable, biocompatible foam that consists of a

severity of ulcers, V.A.C VeraFlo therapy initiated

lower surface that allows for cellular infiltration and

with a cleanse choice dressing, taken to Operating

provides a scaffold for the dermis reconstruction,

Theatre for staged debridement and VeraFlo therapy,

with a sealing membrane over the top. This acts as a

SomaGen dermal matrix placed as tissue scaffold for

scaffold for granulation tissue to enter with a seal to

tissue replacement, Salera placental allograft placed

prevent tissue coalescing on the surface. It modifies

to optimize healing, Incisional V.A.C therapy initiated

the granulation and scar to form a dermal-like layer.

with PREVENA CUSTOMISABLE dressing immediately

Once the clinician has debrided the wound, it has a

following closure.

missing dermis that needs to be reconstructed. BTM can be draped over the wound like a garment,with

The summary of this situation concluded that an

© Copyright. Wound Masterclass. 2023

pieces

placed

in

opposition

(edge-to-edge)

Wound Masterclass - Vol 2 - December 2023

63

Global Innovation in Wound Care Summit Series: What Do I Need to Know About Skin Substitutes?

“The polymer in BTM doesn't get digested and therefore it can integrate if the fluid collections are drained and the infection treated using standard of care.”

and secured in place using staples or sutures. Over

Wagstaff continues to explain that the indications

a period of 2-5 weeks, depending on the age and

for using this approach would be in deep wounds

physiological state of the patient, the tissue grows

that are unable to support a skin graft (exposed

into the foam and integrates, as confirmed by

bones that have been drilled or burred to a point

capillary refill. The top layer can then be delaminated

of bleeding, exposed tendons, or exposed vital

by gently peeling off the sealing membrane. Once this

structures), wounds susceptible to graft contracture

layer has been removed, there is a nice bed for skin-

(across the joints and/or neck area), where there is

grafting to occur.

indication of an improved outcome in comparison to a skin flap (too bulky or local flaps unavailable), and if

Prof. Wagstaff explains that even during the early

the patient is unfit for a longer procedure.

outcomes of BTM treatment, the coverage of the skin was soft and robust in appearance and texture.

There is a better reconstructive approach when

Global expert

initiating treatment with BTM, in comparison to

Dr John Lantis

simply debriding the wound before undertaking skin-

Chief and Professor of Surgery, Mount Sinai West Hospital and Icahn School of Medicine

grafting methods. There are 3 major ops for burns to consider:

New York NY, United States

1.

Day 0; Immediate excision

2.

Day 2-3; Re-excise and apply BTM to wound.

and Dr J. Lantis around his experience with skin

Simpler than grafting, less invasive and shorter

substitutes. Lantis is a leading expert in this field of

operation

wound care and Dr Shamsian begins the questioning

We now go to the discussion between Dr N. Shamsian

by asking specifically about what the potential biggest 3.

3-5 week cooling off period; graft when the

change over the last decade in clinical practice is.

patient is physiologically well and integrated,

Lantis responds to state there has been exponential

all superficial wounds healed means there is

growth in the number of substitutes available for

more donor site, patient is systemically stronger,

experts and clinicians to utilize in the hospital setting,

nutritional support, joints mobilized and there is

and an amplification in the media regarding patients

more reliable and faster donor site healing

being more aware of the products available; what is deemed the most beneficial and appropriate within

64

Wagstaff mentions that this approach means that

practice. Lantis further explains that there is an

burn management has been less tiring and stressful,

emphasis on experimenting with novel products more

and that the results are more reliable with the quality

arduously, hence the development and proliferation

of scarring improved. Dr N. Shamsian questions

of fish-skin substitution. Acellular fish-skin is now

whether the BTM can become infected, to which the

being considered a close substitute that Dr Shamsian

informed response is that BTM prevents dressing

classifies as a biological substitute, demonstrating

activity or physical cleansing to the wound site,

a closeness to human skin. Lantis explains that

so colonization or collections can occur. Wagstaff

fish-skin has an extracellular matrix coming from a

notes that this tends to happen around the second

xenograft and is a non-human source. The primary

week of treatment, however, BTM is like a petri dish;

mode of obtaining this type of substitute is through

the underlying tissue is agar, and that is not what

Icelandic Cod, through medical analysis, which has

becomes infected. The polymer in BTM doesn't get

a consistency of cells embedded within a network

digested and therefore it can integrate if the fluid

of non-living tissue; a likeness to that of human

collections are drained and the infection treated

skin. Lantis explains the overview of the product as

using standard of care.

follows; Acellular fish-skin for medical use patented

Wound Masterclass - Vol 2 - December 2023

© Copyright. Wound Masterclass. 2023

Global Innovation in Wound Care Summit Series: What Do I Need to Know About Skin Substitutes?

“Allografts can cause failure, if the skin graft is rejected by the host. Embryonic tissue has a dense barrier membrane with no cellular ingrowth, inhibiting the healing process and regeneration of tissue.”

by Kerecis. Fish-skin consists of cells embedded in

time and can either be a singular application or

a network of non-living cells (like human skin). CE

reapplied as a sequential depending on factors such

marked and FDA cleared. Manufactured with 100%

as physiological conditions of the patient. We can

renewable energy. Proteins and lipids are maintained

consider fish-skin to be a multiple-use product due

in their natural state. Decellularized and sterilized,

to this situation, where the single application can be

non-allergenic and biocompatible. Contains a biologic

carried out in the hospital setting, or at outpatients as

matrix, cells initially removed from the product itself.

a multiple-use product.

Lantis further explains that it is rare for people

Lantis further endeavors to state that there are four

to have an allergic or anaphylactic reaction to the

hallmarks of Kerecis Technology.

substitute as it is made from cod-skin (a fish), rather than produced from shellfish which is a common

1.

allergy in the modern age.

Natural structure

3-D

Structure

with

–

chemical

Instant

natural

complexity

is

immutable by synthesis or even the most Excluding the scales and DNA associated with fish,

advanced

engineering,

natural

tissue

specifically cod, the skin itself is identical to human

degeneration, rightpore size, chemicals and

skin and the benefit is that viruses in cold water fish

signals, fatty acid profile and tensile tissue

do not have utility within human bodies, therefore there is no risk of contamination of disease associated

2.

Natural Mechanical Properties – Strong and

with fish. The cells are removed using a gentle

preservers superior handling characteristics,

process, otherwise classified as ‘Patented Processing’.

handles like skin, pliable and easy to suture and

This removes the risk for a harsh viral inactivation

staple, surgeons favor this for ease and efficacy

process by a lack of transmission risk, and therefore

3.

Natural Molecular Content – Lipid rich biological

no strong alcohols, detergents, mechanical pressing,

barrier that protects against pathogens, limits

or tampering is needed. These factors have a major

irritation, and modulates tissue response with a

benefit on the cost-effectiveness at market value

chemical complexity of the fish skin promoting

with no crosslinking. All of the skin components are

rapid skin regrowth and neovascularization

Omega3 rich and provide proteins, glycans and fats that humans require to regenerate healthy layers of

4.

Natural Molecular Organization – Unique gentle

skin; encouraging the healing process. Lantis explains

processing, thousands of proteins, lipids and

that the graft is applied to human wounds where it

glycans are natively organized and mimic natural

recruits stem cells and regular cells to facilitate the

tissue ingrowth

tissue regeneration.

Fish-skin is a robust substitute and can be combined When we compare fish-skin substitution to human

with mesh when applying to the surface of the wound.

allografts and embryonic tissue, there are differences.

Lantis explains that in this instance, it is better to affix

Allografts can cause failure, if the skin graft is rejected

the material with either staples or sutures for security

by the host. Embryonic tissue has a dense barrier

and a tactile approach that is less invasive or painful,

membrane with no cellular ingrowth, inhibiting the

essentially improving patient outcomes. Cod is a very

healing process and regeneration of tissue.

large fish so the sheets of fish-skin are essential for larger wounds. The molecular content breakdown

A key phrase of viewing the fish-skin like a dermal

is as follows; Collagen, Elastin, Laminin, Fibronectin,

scaffold

when

Proteoglycan, Glycols amino-glycans, Lipids (with

deliberating the effectiveness of technique and

Omega3). Alongside this beneficial structure, the

application. Lantis explains that the product itself

pore size of fish-skin is similar to human skin as well

modulates the wound bed, which can be seen over

as being very thick. Lantis goes on to explain ‘How

© Copyright. Wound Masterclass. 2023

is

an

essential

consideration

Wound Masterclass - Vol 2 - December 2023

65

Global Innovation in Wound Care Summit Series: What Do I Need to Know About Skin Substitutes?

“Some of the indicators for using fish skin would be diabetic foot wounds, venous leg ulcers, post-surgical wounds, burns, and skin-graft donor sites.”

To Use’ or ‘Best Practice’ when applying this as a

of Kerecis begin to adhere to the wound bed, they

substitute in 8 steps;

should be removed with a reapplication of new sheets if those have been partially absorbed or are no longer

1.

Remove necrotic tissue

visible. It is essential to change the wound dressing to maintain the moist environment.

2.

Remove exudate and control bleeding

3.

Remove the fish skin sheet from the pouch in an

temperature in a sterile packaging which will ensure

aseptic manner

a minimum of 2-year shelf life. It is important to note

The fish-skin itself should be stored at room

that they will be delivered in boxes of 10, which is 4.

Cut the sheet roughly to the size of the area to be

essential when managing patients that require a

covered

multiple-use purpose. Some of the indicators for using fish skin would be diabetic foot wounds, venous

5.

Pre-hydrate with NaCl solution

leg ulcers, post-surgical wounds, burns, and skin-graft donor sites.

6.

Apply sheet to wound, ensure no overlap of wound edges

A

double-blind,

randomized

clinical

trial

was

conducted on 162 wounds (81 patients) where one 7.

More than one sheet may be necessary for

wound was treated with Porcine and the other with

complete coverage. Overlap sheet edges to

Fish-skin as a substitute. The fish-skin demonstrated

ensure coverage

a significantly faster healing rate, and the same model was reproduced 5 years later with Fish-skin against

8.

Apply appropriate non-adherent wound dressing

Amnion/Chorion Products, which, again proved a

to maintain moist environment

significantly faster healing rate.

Dr N. Shamsian goes on to question ‘Are you doing

A study specifically for diabetic foot wounds where

something similar with this technique, and with a skin

Fish-skin was utilized vs. SOC (Standard of Care), once

cavity, are you overlapping the sides of the so the

again proved a faster healing rate. It is important to

defects are covered?’, to which Lantis responds with

consider that this study was conducted on significantly

a ‘Yes’. Allowing the wrap up to go around the size,

‘sicker’ patients with a preemptive comorbidity, in

even when you don’t have the right size substitute,

comparison to the previous 2 studies that were

with someone experienced in this area of treatment

conducted on younger and healthy individuals. The

you can morcellate or cut-up the product not to cover

wounds were harder to heal in the initial stages due

the entire wound, even though the preference is to

to this physiological condition, but again the efficacy

cover the entire area. Bu using deep quilting stiches,

was proven, and patients complained more about

we cauterize the defects that occur, and it is essential

pain and infection risk when utilizing the approach of

to keep this area moist as, if the area becomes dry,

SOC, in comparison to that of the fish-skin. Therefore,

the material may not stick to the wound, as described

we can deduce that fish-skin is more cost effective

by Lantis with the following anecdote: A fish does not

and improves overall patient outcomes.

like to be out of water.

There are wounds that fish skin would not be Follow-Up

appropriate to use as a form of management and/or treatment, and this includes (but is not

66

Inspect the wound every 2-3 days depending on the

limited too); Acutely infected wounds (cellulitis),

amount of exudate, followed by cleaning the wound

over untreated osteomyelitis (bone infections not

areas as needed. If the previously applied sheets

previously treated), or directly over anastomosis.

Wound Masterclass - Vol 2 - December 2023

© Copyright. Wound Masterclass. 2023

Global Innovation in Wound Care Summit Series: What Do I Need to Know About Skin Substitutes?

Lantis gives the audience some helpful tips and tricks

every patient is the same. Product ‘X’ may be used

when considering the utilization of fish skin substitution:

for a period, then we move to a combined approach

Cut to size once the substitute is dry. Fenestrate

with fish- skin substitution, then we may add human

when wet.Suture whenever possible (Chromic suture

skin. There is no scope for layering the methodology

are best applicable). You can sew to the base of the

as of the moment, Lantis explains, but having this

wound. Keep the area hydrated (cover with Hydrogel).

combined approach to treatment may improve the

Finally, Dr N. Shamsian concludes by questioning ‘In

healing response. Even though there are new biologic

terms of the future for skin substitutions, what will the

and non-biologic products being adapted and tested

next stage be?’ and Lantis explains that essentially,

all the time, the future is uncertain without the

we need better algorithms as clinicians. We need

essential need for an algorithm that is informed and

to look at wounds with the understanding that not

based on specifics like disease or wound type.

Supported by

© Copyright. Wound Masterclass. 2023

Wound Masterclass - Vol 2 - December 2023

67

Biodegradable Temporising Matrix

For the reconstruction of diabetic foot wounds and venous leg ulcers.

BTM supports cellular migration and formation of neodermis.1, 2 It provides a porous framework that bioabsorbs, leaving a robust vascularized dermal layer.3 A temporary sealing membrane protects the wound while the body heals.4

Infected Diabetic Foot Ulcer

Wound prior to debridement

Follow up at 4 months post grafting

Discover more at: polynovo.com

Refer to the Instructions For Use for full device details. References: 1. Greenwood JE, Schmitt BJ, Wagstaff MJD. Experience with a synthetic bilayer Biodegradable Temporising Matrix in significant burn injury. Burns Open. 2018;2(1):17-34. 2. Wagstaff MJD, Salna IM, Caplash Y, Greenwood JE. Biodegradable Temporising Matrix (BTM) for the reconstruction of defects following serial debridement for necrotising fasciitis: A case series. Burns Open. 2019; 3:12–30. 6. Data on file. 3. Wagstaff MJD, Schmitt BJ, Coghlan P, Finkemeyer JP, Caplash Y, Greenwood JE. A biodegradable polyurethane dermal matrix in reconstruction of free flap donor sites: a pilot study. ePlasty 2015; 15:102–18. 4. Greenwood JE, Dearman BL. Split-skin graft application over an integrating, biodegradable temporising polymer matrix: immediate and delayed. J Burn Care Res 2012; 33(1):7–19. ® PolyNovo and NovoSorb are registered trademarks of PolyNovo Biomaterials Pty Ltd.

woundmasterclass.com/Podcast

MasterSeries 60 Minutes Interactive Clinical Challenges and Solutions in Palliative Wound Management

Global expert Prof Georgina Gethin Professor of Nursing, Head of School of Nursing and Midwifery, University of Galway

serious health related suffering (SHS). This has been divided into two areas: •

with illness or injury of any kind

Galway, Ireland

•

Defining the Concept Of Palliative Wound Care

Suffering is health-related when it is associated

Suffering is serious when it cannot be relieved without medical intervention and when it compromises physical, social or emotional functioning

The World Health Organisation (WHO) defines palliative care as “an approach that improves the

Palliative care should be focused on relieving the SHS

quality of life of patients and their families facing

that is associated with life-limiting or life-threatening

the problems associated with life-threatening illness

conditions or the end of life. This illustrates how

through the prevention and relief of suffering

palliative care is not confined solely to end of life care,

by means of early identification and impeccable

but it goes beyond the spectrum; this is important for

assessment and treatment of pain and other

understanding palliative wound care.

problems, physical, psychosocial, and spiritual”. This is a very comprehensive definition, but as with many

The Lancet Commission recommends that the

other things, it is not without its critics.

definition be reviewed and revised to encompass health-system advances and low-income settings

The Lancet Commissions looked at palliative care, as

where medical professionals often have the difficult

well as WHO’s definition. In their publication they

task of caring for patients without necessary

looked at “Alleviating the access abyss in palliative

medicines, equipment, or training.

care and pain relief – an imperative of universal health

Supported by

coverage”.1 The document highlights the severe lack

The commission recommends a definition that

of access to healthcare that people in different parts

explicitly rejects any time or prognostic limitation on

of the world experience. An example of this includes

access to palliative care, includes complex chronic

how morphine for pain relief is inaccessible for

or acute, life- threatening, or life-limiting health

thousands of people.

conditions, and considers all levels of the healthcare system from primary to specialised care and all

70

The commission developed a new conceptual

settings where palliative care can be delivered. Thus,

framework for measuring the global burden of

the commission treats palliative care as an essential

Wound Masterclass - Vol 2 - December 2023

MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management

“The commission treats palliative care as an essential component of comprehensive care for persons with complex chronic or acute, life-threatening, or life-limiting health conditions that should be practised by all healthcare and social care providers and by palliative care specialists, and that can be provided in any health-care setting, including patients’ own homes.”

component of comprehensive care for persons with

Their final definition concluded that palliative care is

complex chronic or acute, life-threatening, or life-

the active holistic care of individuals across all ages

limiting health conditions that should be practised

with serious health-related suffering due to severe

by all healthcare and social care providers and by

illness and especially of those near the end of life. It

palliative care specialists, and that can be provided

aims to improve the quality of life of patients, their

in any health-care setting, including patients’ own

families and their caregivers.

homes.

Further research sought to carry this definition over Following these findings, a new document was

into the field of palliative wound care. One particular

created with the aims of redefining palliative care, and

paper carried out a Q methodology to look at how

most importantly this new definition was consensus

nurses frame palliative wound care.3

based.2 This was led by the International Association for Hospice & Palliative Care. The process involved

This links back to an earlier point regarding how

in creating this new consensus based definition is

important it is to have a concept or definition which

important to note, considering how critical it is to

therefore reduces, or at the very least minimizes,

understand who the thinkers behind something

this subjective notion of what is and is not palliative

are. Critical to their work, they used a three-phased

wound care, and who receives treatment from

consensus process involving healthcare professionals

various specialists and who does not.

from countries in all income levels: A common trait shared by all 4 Q-factors is the •

Phase 1: 38 Palliative care experts evaluated

perception of palliative wound care as an approach to

the components of the WHO definition and

improving the quality of life of end-of-life patients that

suggested new/revised ones

includes holistic patient care, family support, effective communication, and interdisciplinary teamwork. In

•

Phase 2: 412 International associations for

this perception it was very clear that the focus was

hospice and palliative care in 88 countries

very narrow.

expressed their level of agreement with the suggested components

The 4 subjective frames on palliative wound care by wound care nurses are as follows:

•

Phase 3: The expert panel developed the definition

•

“Focusing on care within the boundary of current patient demands”

Figure 1 shows a mapping of geographic areas included in their consensus. It does not solely show

•

the number of countries, but also shows how it was

“Comparing continuously the priorities on wound healing and disease care”

spread over high upper middle, low upper middle-, or low-income countries.

•

“Preparing and preventing from worsening via tracking care in advance”

Figure 1: Geographic areas included in the consensus.

•

“Moving forward with a clear direction by confronting the declining condition”

1 2 3 4 Low income Lower-middle income Upper-middle income High income

The first frame may be deemed as the most reflective on the matter, as it focuses on care within the boundary of patient needs. It is a very patient focused concept, not a one-size-fits-all approach.

Wound Masterclass - Vol 2 - December 2023

71

MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management

“It is a very patient focused concept, not a one-size-fits-all approach.”

Through the task force the aim is to define the concept

definitions and scopes on the matter to become very

of palliative wound care through a scoping review

limited to these Western countries.

of the literature, to conceptualize palliative wound care in terms of its definition, elements, and any

It

differences with general wound care management

commentaries (n=70), while the remaining were

(preliminary findings). The aim was to do this via a

book chapters (n=11), case reports or case series

methodologically sound approach that would be

(n=9), consensus statements (n=6), prospective

accepted by all; therefore, the meta-aggregative

and observational studies including cohorts (n=6),

approach was ideal as it guided researchers to pool,

conference

compare and summarize data to understand the

descriptive quantitative studies including surveys

definition and concepts of palliative wound care.

(n=5), qualitative studies (n=4), retrospective studies

There were 4 stages in this:

(n=3), theses (n=3), and other (n=11).

1.

Development of the review question and search

It also included a range of aetiologies; this is vital

strategy

because palliative wound care is often viewed via

Literature searches, screening and data

the lens of cancer care, so it would be expected that

extraction

much of it was focused around malignant fungating

Pooling of all the extracted data and mapping of

wounds. However, in this research, the opposite

main and sub-categories

was found instead, in that 46% had a broad range of

Further data synthesis

wound aetiologies, and 22% had malignant fungating

2.

3.

4.

included

systematic

abstracts

reviews,

including

editorials

posters

or

(n=5),

wounds; therefore it was really strong.

The inclusion criteria consisted of reports that refer to the definition, concept, components, elements,

The most repeatedly used phrases were unsurprisingly

principles, or goals of palliative wound care as a

about symptom management, and quality of life. Also,

primary or secondary source; pieces of literature

psychological or psychosocial issues, and symptom

(including grey literature) that follow any methodology

control.

and design; published any time (no year limits), and published in English. The searches were performed in the following electronic databases: Ebscohost CINAHL Complete, Ovid Medline, Cochrane Library, and Scopus. Google Scholar was also searched to identify additional reports.

•

2694 records were identified for title and abstract screening

•

196 full texts reports were read in detail

•

133 were included in the data synthesis

Most of the reports were from or led by authors from the United States (n=56), United Kingdom (n=24), and Canada (n=10), followed by European countries (n=17).

Unlike palliative care research being taken from all countries and all income settings, palliative wound care is a lot more restricted and niche, causing for

72

Wound Masterclass - Vol 2 - December 2023

Figure 2: Wound aetiology.

MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management

“This new concept is in attempt to capture all the various core elements of what palliative wound care is.”

Emerging from this were 3 key themes, the first being

factors that patients encounter, and that requires a

palliative wounds, looking at the types of wounds,

pain specialist. There is much more engagement and

the healing potential, and the patient population it

interaction on an ongoing basis. Focusing on patient

affected; secondly, the impact on individuals and

and family goals requires the constant assessment

family, which regarded things such as social isolation

of what the needs are of the patient, and what their

and distress, the quality of life, and their function and

goals are. For example, this may include control of

wellbeing; finally, the care approach - what were the

odour, or control of bleeding, etc.

goals, principles, and existing needs of the patients.

There are some similarities between the two, but the This new concept is in attempt to capture all the

major difference is that the focus is not on healing, but

various core elements of what palliative wound care

rather on the symptom management, and alongside

is; that is, person and family centred, holistic and

this there is a large focus on psychological wellbeing.

interdisciplinary care of wounds that may heal, or not, or may be too onerous to treat; including but not limited to symptom control and management, for individuals who are often vulnerable and have impaired quality of life. This comes from over 100

Table 1: TIME (tissue, infection/ inflammation, moisture, edge), wound bed preparation, a range of potential nursing interventions, methods, and generic products for palliative wound care.

documents reviewed.

Comparing Palliative Care with Palliative Wound Care

TIME

Wound bed preparation

Methods and generic products for palliative wound care

Tissue Necrotic

Debride the necrotic tissue

Autolytic debridement: hydrogel, hydrocolloid, honey, alginate, hydrofibre dressings Biological debridement: larval therapy

It compares very well because it includes being person centred, holistic, multi-disciplinary, not limited

Mechanical debridement: ultrasound

to end-of-life care, not limited to cancer care, and with a large focus on quality of life. This looks to the quality of life for patients, but also of families and carers. Looking at the concept of palliative wound care brings the question of what the difference is

A chapter in the Oxford Textbook of Palliative

between palliative and curative wound care. Emmons

Medicine has been updated, using the time-based

and Lachman have produced a lot of work regarding

approach in order to look and see how we would

this matter, however the principles of what they have

address and approach palliative wound care, in

stayed through, even to today. Essentially, in general

comparison to general wound care.5 Using the time

wound care, the goal is healing. It could be to control

anacronym (tissue, infection/inflammation, moisture,

and eliminate causative factors, for example pressure

edge, or epithelial edge advancement), looking at

in the area of pressure ulcers. Also, to provide

necrotic tissue for example, it may be to debride

systemic support to reduce existing and potential

them, and then seeing what agents may be suitable

cofactors, and to maintain a local environment that

for it. However, this depends on a comprehensive

promotes healing. When the goal is palliative, the

assessment of the patient, the wound, and of the

focus is symptom management, psychological well-

goals of care.

4

being, multidisciplinary team approach, and a focus on patient and family goals. One could argue that a

The palliative wound care framework is driven by

multidisciplinary approach is required in all cases, and

patient and family goals integrated with:

it is. However, in the area of palliative wound care, it is more evident, and it is more necessary on a dayto-day basis. For example, pain is one of the major

•

Management of palliation of the underlying cause

Wound Masterclass - Vol 2 - December 2023

73

MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management

“Odour control is one of the key components of palliative wound care.”

Management of wound related symptoms: pain,

The goals are to provide comfort and maintain the

odour, exudate, and bleeding

best possible quality of life. These include:

Management of the wound and peri-wound skin

•

Pain management

To summarise, palliative wound care is not time

•

Symptom control

•

Wound odour management

•

Preventing wound complications

•

Education and support for caregivers

•

Honouring the patient’s preferences and goals

•

•

limited and is focused on patient and family goals.

The concept of palliative wound care can guide policy, resources allocation and services provision. Major wound symptoms include pain, odour, exudate and bleeding. Palliative wound care differs from general wound care in many areas but particularly for the outcome of healing. There is also a critical need and importance for research to develop this area of practice. In palliative care there are multiple different wounds that can affect patients at the end of life.

Odour control is one of the key components of

These wounds are those that are not amendable

palliative wound care. It has been found that medical

to healing at this point in time, and the focus is on

practitioners working in wound care have become

what the patients desires are. These can be any

desensitized to the odour. However, a key aspect

kind of wounds from venous wounds to chronic

concerns how children do not want to be around this

osteomyelitis, any kind of wound where the goal is

odour, and as the patient would like to be around

no longer aggressively healing, but to maintain the

grandchildren and family members, it is vital to

environment and prevent the wound from becoming

maintain an environment where they can do so.

an issue for the patient. Palliative wound care is slightly neglected, and is not very well known in the

Wound Challenges

field of chronic wounds. The focus is on maintaining the quality of life for the patients, therefore more

Palliative care patients often have complex wounds

focus is placed on symptom management to have a

including pressure injuries, wounds related to chronic

better quality of life, and here dressings can be used

diseases, vascular impairments or malignancies and

to lower wound odour, for example.

they pose challenges due to their size, depth, varied aetiologies, and associated symptoms like pain Global expert

Dr John David Thomas CEO/ Medical Director for Solutions Medical Group

and drainage. healthcare providers must have the expertise needed to evaluate, treat, and manage these complex wounds effectively.

Symptom Control

Humble TX, United States

The symptom control is important to handle the

Challenges Faces in Palliative Wound Care

excessive exudate drainage and malodour infection.

The drainage can be overwhelming at times, and

My aims and objectives are to identify the challenges

therefore a highly absorbent dressing is required

in daily practice, the challenges in the management

to control the odour and keep the wound from

of palliative care wounds, and identify examples

macerating and creating further complications. It

of skin damage and palliative wounds, including

is easier for a saturated wound to become infected

pathophysiology.

and have significant malodour. Zetuvit serves as an excellent choice for a dressing and may be regarded

74

Wound Masterclass - Vol 2 - December 2023

MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management

“Stigma and misconceptions around palliative wound care include the mistake of associating palliative care with hospice care, or end of life care, and it is not necessarily the same.”

as the best dressing in wound care today.

There are different dressings showing the absorption of bacteria, and Figure 4, Table 2 shows the different kinds of dressings available on the market that are

Figure 3: Zetuvit Plus Silicone/Border Structure and Mechanism of Action.

lowering the bacteria loads, whether it is in the dressing or that they release their components to eradicate the bacteria and to lower the mmps. Odour management and pain management can be classed as the two most important components in palliative care.

Figure 4: Standard of Care vs superabsorbent dressings.

Wound healing

Increased QualityAdjusted Life Weeks

Quality of life

2.9% increase in healing rate

Cost

£222 saved per person over six months

Standard of Care

Superabsorbent dressings

Standard of Care vs Superabsorbent Dressings Table 2: Examples of Non-Medicated Wound Dressings exhibiting absorption of bacteria, MMPs and endotoxins into the matrix of the wound dressing.

Considering standard of care vs superabsorbent dressings, a 2.9% increase in healing rate is shown with the superabsorbers due to the fact they keep the

Foams

Krejner and Grzela, 2015

CMC dressings

Newman et al., 2006; Walker et al., 2003

Superabsorbent polymer (SAP)-containing dressings

Eming et al., 2008; Wiegand et al., 2011; Wiegand and Hipler, 2013; Wiegand and White, 2013

Dialkylcarbamoylchloride (DACC)-coated dressings

Bowler and Davies, 1999; Ljungh et al., 2006; Ronner et al., 2014; Wadstrom et al., 1985; Butcher, 2011; Brackman et al., 2013; Geroult et al., 2014

or simply become less of a burden to the patient, this

HRWDs

Rippon et al., 2018; Bruggisser, 2005; Ousey et al., 2016

the quality of life, whilst saving costs.21-35

Table 3: Examples of NMWDs with evidence of sequestration of bacteria.

correct environment for a wound. In palliative care it is not necessarily about healing the wound, but if a wound heals during the care this is a good outcome.

If the chances of the wound healing can be assisted, is a goal that would be highly favourable; it increases

Stigma and misconceptions around palliative wound care include the mistake of associating palliative

DACC-coated dressings

Bowler and Davies, 1999; Ljungh et al., 2006; Ronner et al., 2014; Wadstrom et al., 1985; Butcher, 2011; Brackman et al., 2013; Geroult et al., 2014

care with hospice care, or end of life care, and it is

HRWDs

Rippon et al., 2018; Bruggisser, 2005; Ousey et al, 2016

mistakenly viewed as surrendering or losing hope and

Hydroconductive

Edwards-Jones et al., 2014

CMC dressings

Newman et al., 2006; Tachi et al, 2004; Walker et al., 2003; Bowler and Davies, 1999; Waring and Parsons, 2001

SAP-containing dressings

Butcher, 2015

Others

Desroche et al., 2016; Westgate and Cutting, 2012

not necessarily the same. Palliative care is likely to be delaying access to appropriate services. End of life care is much different to palliative care. It is possible for a patient to be in good health with good amount of years ahead of them, and still require palliative

Wound Masterclass - Vol 2 - December 2023

75

MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management care. For healthy elderly patients with open chronic

as possible.

wounds, treating the wound to heal it would take up valuable time in which the patient could be spending

Examples of Skin Damage and Palliative Wounds,

time with their family, rather than being in the clinic

Including Pathophysiology

daily. A palliative care option is much better for this case as it would enable the patient to maintain a

Pressure injuries

proper wound environment, whilst not disturbing the ability for the patient to enjoy the rest of their life.

•

Pressure ulcers develop due to prolonged pressure on the skin, particularly over bony

Another challenge involved with palliative care

prominences

regards communication. Effective communication with the family members of the patient, as well as

•

Pressure disrupts the delivery of oxygen,

all of the nursing staff is imperative to ensure that

circulation, and nutrients, resulting in tissue

the goal and focus is clear. There may be cultural

ischemia and subsequent breakdown

and language barriers with family members, as well as conflict, as there may not be a shared goal with

A lot of palliative patients tend to be more sedentary,

how to proceed with the patient’s care. It is crucial to

causing for skin to breakdown and pressure ulcers to

ensure they understand and are informed during the

be formed. It is important to maintain an environment

process.

where the patient is moving and kept clean and dry.

This is a great contrast to end of life care where the

Care coordination is also vital. The need for

patient is mainly kept comfortable in bed.

coordination arises from the fact the patient is in various

healthcare

settings,

including

hospitals

Osteomyelitis

and home care. Ensuring smooth transitions and consistent delivery of care can be a challenge,

•

Very conservatively treating open wounds

especially when patients have complex medical

combined with stopping antibiotic therapy can

requirements or frequent hospital readmissions.

set the stage for the development of infection,

Communication also proves to be very important in

osteomyelitis, and sepsis

this matter.

The bacterium is highly resistant, and the effects There is also the need for psychosocial support

of antibiotics may be detrimental to the patient.

and ensuring for sensitivity and compassion. This

Maintaining an environment that is conducive to

will help to establish a supportive environment

the patient’s life goals and reducing the infection,

where patients and families feel comfortable. The

drainage and odour will greatly assist this problem.

challenge is essentially preventing complications.

The primary focus is on comfort and symptom

Malignant wounds

management. Exudate wounds can lead to infection and tissue breakdown with maceration. Preventing

•

Malignant wounds arise when cancer infiltrates

complications looks heavily to control exudate and

the skin or occurs due to tumour growth. This

drainage. By successfully controlling this, the odours,

can happen through direct invasion, metastasis,

maceration and tissue breakdown become reduced,

or tumour necrosis. Malignant wounds are

possibly even helping the body to continue to heal.

often irregularly shaped, friable, malodorous, have exudate, bleeding and/or necrotic tissue.

Pain management is another vital aspect for the

They can be painful and prone to infection

patient, and one of the most prevalent issues with this is changing the dressing. Changing the dressing

Wound vacs can be used for malignant wounds. They

is uncomfortable for them, therefore changing the

are usually contraindicated for cancer, but in palliative

durations and frequency of this can help reduce the

care, it can be used to control exudate flow. It is not

amount of discomfort the patient endures. Super

about healing the wound, but rather controlling

absorbent dressings with silicone base are excellent

odour and drainage.

for fulfilling this goal as the silicone base will not stick to the wound and the super absorber would wick

Venous Leg Ulcers (VLUs)

away the moisture from the skin, providing a longer duration between the dressing changes. Lots of the

76

•

Chronic venous insufficiency, which leads

patients have opioid tolerance, hence the importance

to venous hypertension, compromised

to reduce the stimulation to the wound as much

microcirculation, and tissue injury

Wound Masterclass - Vol 2 - December 2023

MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management •

Typically occur around the ankles and lower legs

•

Often present as shallow, irregularly shaped wounds with a moist wound bed, surrounding edema, heavy exudate, and hemosiderin staining in periwound

require lots of compression dressings, and patients are usually at this point tired of chronic wound care.

These kind of wounds have a high amount of exudate; therefore, it is important to develop a plan to treat the wounds and keep the exudate down to reduce maceration or destruction of tissue.

unaware that they are harming the wound and making it worse. Considering the patient’s situation diet, it is important to communicate properly with the patient and family, ensuring they can still enjoy life but maintain a proper environment that will not harm the wound further.

Surgical wounds Incision and tissue trauma

Surgical wounds regard another issue where the

Arterial ulcers develop due to inadequate arterial blood supply to the lower extremities caused by peripheral arterial disease, atherosclerosis, and/or arterial restriction or occlusion

treatment offered in palliative care may not be accepted by surgeons as they are not as open to it.

Due to the lack of understanding regarding palliative care, some of the treatments and plans are not accepted well as the surgeon would often have their strong opinion of the wound and how they would like

Reduced oxygen and nutrient delivery result in tissue ischemia and ulceration

•

peripheral neuropathy makes it so the patient is

•

Arterial ulcers

•

They are a huge problem in wound care. The

of also living with diabetes and being put on a strict

Venous leg ulcers can be difficult to treat; they

•

prompt treatment is delayed.

to handle it. This is where communication with the patient and surgeon proves to be vital.

Typically located on the feet, toes, or lateral

Global expert

ankle •

Prof Sebastian Probst Immediate Past President EWMA Full Professor of Tissue Viability and Wound Care at the School of Health Sciences

Characterized by deep, “punched-out” wounds with minimal exudate, pale granulation

Geneva, Switzerland

tissue, and surrounding ischemic changes like coolness, shiny skin and hair loss Arterial wounds can be very painful, and, in this situation, it is important to notice the aetiology of the wound, and what the goals are. In palliative care, invasive treatments can still be done such as angiogram with intervention, in order to decrease pain rather than trying to heal the wound.

non-healable wounds or palliative wounds such as malignant fungating wounds.6

perception of wellbeing, happiness and satisfaction

Diabetic foot ulcers (DFUs) occur due to peripheral compromised

Quality of life is often more relevant for people with

Generally, quality of life is defined as a general

Diabetic Foot Ulcers (DFUs)

neuropathy,

Quality Of Life for Patients with Palliative Wounds

circulation,

trauma,

impaired wound healing associated with diabetes and hyperglycaemia; neuropathy leads to decreased sensation, making patients prone to repetitive trauma and pressure injuries.

Diabetic foot ulcers primarily affect the feet, particularly areas subject to increased pressure. They are often deep, with a necrotic base, undermined edges, and signs of infection. With peripheral neuropathy, these wounds often go undetected and

by an individual. It is a subjective but dynamic concept influenced by functional capacity, past experiences, personality,

self-esteem

and

interprofessional

relationships. Quality of life refers to the sense of wellbeing that is specifically associated with health and illness. A quality of life goal may be to reduce pain and prevent suffering. Striving for quality outcomes in patients with non-healing or palliative wounds is particularly significant when wound healing is not a realistic outcome. The complexity of quality of life is often understood in terms of overlapping dimensions. The different components may carry more importance at a given time based on the context

Wound Masterclass - Vol 2 - December 2023

77

MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management of health and illness.

wounds due to the exudate being manageable, however it became worse and the furthest the patient

Functional Limitations That Wounds May Have On

could walk to was their garden. The patient would

Patients

then stay in bed.

•

Palliative wounds, especially those in

This kind of incident can trigger many

challenging locations or with significant size

psychological issues such as:

or drainage, can limit a patient’s mobility and independence

•

Effects of wounds on patients’ sense of self

Resulting in decreased ability to perform daily

•

Impact on relationships

and recreational activities

•

Lack of sleep

Strategies such as assistive devices, wound

•

Frustration

implemented to optimize functional capabilities

•

Exudate

Social support is very important. Engaging patients

•

Malodour

•

Depression

•

Altered body image

enhance the time they have with their families.

•

Social isolation9

Cancer Diagnosis and Palliative Wounds

Negative Impact on Quality of Life

Living with a cancer diagnosis is traumatic enough

Wound pain management with the frequency of

without the added physical and psychological burden

dressing changes are very important. The dressings

of a malignant wound. In this study, 9 women were

should be very comfortable, especially with the

living with malignant wounds.7 They displayed

exudate and bleeding. Patients are informed what to

the difficult of dealing with unpredictable wounds

do when it starts bleeding, as well as what to do with

because it can produce a lot of odour, exudate, or

malodour.

•

activities, self-care, and participation in social

•

positioning, and rehabilitation services may be

in support groups, connecting them with community resources, involving family and friends in their care, and promoting open communication can enhance social support and improve overall well-being. This will promote a better quality of life for them and

there are problems with bleeding and pain. There may also be the embarrassment of having the wound.

Patients living with such wounds have also expressed their struggles verbally. Their comments range from

Another study illustrates the caregiver’s experience.8

their diet and nutrition compromises to accommodate

It had been concluded that when providing care to a

pain management with their wounds, to the excessive

wound they experience shock, disgust, and nausea.

labour of handling exudate.11 Comments regarding

They had also described feelings of isolation and lack

pain would involve “My sleep and rest always break off

of knowledge for how to care for a wound, especially

because of slight to mild shooting and stabbing pain”,

doing so for their loved ones. These studies show that

“I only eat soft cold noodles and bread, because those

the key to improve quality of life for these patients

can decrease my mouth wound pain”. With exudate

is having access to a wound care team or specialists

they commented that “It [exudate] was festering like

who can educate patients and caregivers on how to

a running nose”, “ had to redo my dressing nearly

care for wounds with the appropriate dressings, how

every four hours because it was leaking”. In regard

to control exudate and wound odours.

to bleeding, they would “always suffer from bleeding after a change of dressing or slight exercise”, and “I

78

As it has been shown with malignant fungating

sought for medical assistance for the wound when I

wounds, they have a profound impact on the patient’s

couldn’t stop the bleeding”. This is problematic with

quality of life. This study shows what kind of impact

for their weight and health. As for the odour, patients

it can have on the relationships of patients and

have commented saying “you might compare it with

their caregivers. For example, a patient’s caregiver

the smell of a piece of rotting meat”, to it being “very

(partner) reported that their ability to move around

stressful when someone told me I stank”. In palliative

was decreasing. Initially, they could travel with their

wound care, it is important to promote comfort,

Wound Masterclass - Vol 2 - December 2023

MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management alleviate pain and prevent infections to optimize the patient’s quality of life, and effectively maintain the wound in a stable, manageable state.

When speaking of wound symptom management, we must look at common therapeutic approaches in palliative wound care. Therapeutics in palliative wound care focus on:

practice. Tranexamic acid can be used in home care, with instructions provided to the caregivers on how to use them if the wound starts to bleed. Additionally, other vasoconstrictions may be used, such as adrenaline. The gauze can be soaked and applied with pressure depending on the pain, not more than 10 minutes. Doing this task under 10 minutes will prevent a necrosis.

•

Promoting comfort

•

Symptom management

•

Alleviating pain

•

Preventing infection

•

Maintaining the wound in a stable and

Darker bedsheets are recommended for the patient to use, to enable the bleeding of the wound does not do further damage on their psychological state, as well as the caregivers. This helps to mitigate panic and the feelings of incompetency as revealed earlier.

For exudate management there are three important

manageable state •

Calcium alginates are used very often in clinical

indicators: the dressing fit, the volume of exudate leakage, and the number of dressing changes.15 Malignant fungating wounds can produce up to one

Optimizing the patient’s quality of life

A Canadian publication from Kevin Wu shows what medical practitioners can do in a clinical practice for the management of pain in palliative wound care.12 Morphine can be used, or topical lidocaine. Dressings with ibuprofen may also be used, and potentially methadone. Capsaicin (0.025 – 0.075%) can be an ointment, and also the dressings including silicon are recommended.

litre of exudate, hence the importance for this.

Superabsorbent dressings should be used to manage heavily or moderately exudative ulcers. Those with a silicone layer should be used. Polyurethane foam dressings have an exudate absorption and an autolysis debridement capacity, meaning it may also be used. It has also been suggested that silverimpregnated foam dressings can be used to lower and protect wounds from bacterial colonization.16 If there is an alginate with silver, it can be covered

In regard to what can be done systemically, the understanding is that up to 70% of chronic wounds have nociceptive pain and neuropathic pain. NSAIDs, opioids and anticonvulsants can be used to address this. A critical literature review reveals that an effective way of using topical morphine is by mixing 10mg of it with 8g of hydrogel. A pharmacist can mix this, allowing it to be applied without any problem. To manage the bleeding in palliative cases, the classical 10 times daily 3 gy fractionation schedule during weekdays is the most appropriate dose.13 Other

easily with another. However, with a superabsorbent dressing you would not require another one, due to its absorption capacities.

Negative pressure wound therapy (NPWT) has been supported as a potential method for exudate management in a palliative setting.17,18 Despite it being a contraindication for a malignancy, if the goal is to alleviate pain and enhance quality of life, and considering the patient’s life, it then could be a possibility. The use of NPWT for malignant wounds

possibilities include topical haemostatic agents:14 Figure 6: Tools for the Subjective Assessment of Wound Odour.

Figure 5: Category

Example

Comments

Natural haemostats

Calcium Alginates Collagen Oxidized cellulose

Controls minor bleeds Available as a dressing material Bioabsorbable

Coagulants

Gelatin sponge Thrombin

Risk of embolization

Sclerosing agents

Gelatin sponge Silver nitrate

May cause stinging and burning upon application Leaves a coagulum that can act as a pro-inflammatory stimulus

Fibrinolytic antagonists

Tranexamic acid

Oral agent Gastrointestinal adverse effects (nausea/vomiting)

Astringents

Alum solution Sucralfate

May leave a residue on wound

Vasoconstriction

Adrenaline

Gauze soaked in adrenaline 1:1000 applied with pressure for 10 minutes

Odour Assessment

Scale System

Visual Analogue Scale

Scale from 1 to 10, where 1 is no odour and 10 is extremely strong odour

Verbal Rating Scale

Scale from 1 to 4, where 1 is no odour and 4 is strong odour

Verbal Rating Scale

Strong (intolerable), moderate (noticeable), minimal (barely noticeable), absent (no odour)

Baker and Haig Method

Scale from 1 to 4, where 1 is strong odour and 4 is no odour

Not indicated

Scale from 0 to 4, where 4 is strong odour and 0 is no odour

Overall Evaluation Scale

Scaled from 1 to 10, where 10 is excellent odour control

Teller Odour Indicator

Scaled from 0 to 5, where 0 is no odour, 4-0 is when odour is sensed during dressing changes and at certain distances from the patient

Wound Masterclass - Vol 2 - December 2023

79

MasterSeries 60 Minute Interactive: Clinical Challenges and Solutions in Palliative Wound Management may have utility as a palliative therapeutic intervention

To summarise, the evidence available and from

to reduce complications associated with the wounds

clinical practices show that palliative wounds can

and to increase patient comfort.

affect the quality of life. A holistic approach to improve the quality of life is needed. In managing

With odour management, it is important to reflect

exudate, superabsorbent dressings would work

how odour is documented. In wound documentations

best. Metronidazole and silver may be used in

regarding odour, there is often a yes or no. To be more

controlling wound odour In a palliative setting, NPWT

accurate, a visual analogue scale would be highly

may be used for malignant wounds. New research

useful. This assessment tool would be beneficial.

is important as it is heavily lacking in the field of

19

palliative wound care.

There are different rating scales to assist document better. This enables a more objective data that is easier to work with. Treatment options to manage wound odour are limited. There is a lack of research, and in the field of palliative wound care the small sample sizes are very low. Are also an absence of defined standardized outcomes and consistent measurement. The widely used topical application, for

See all Wound Masterclass MasterSeries on demand:

Visit HARTMANN LINK

bigmarker.com/wound-masterclass

linkforwoundhealing.info

example metronidazole may be used. Metronidazole and silver may have a role in controlling wound odour.

Robust and well-designed interventions standardized odour outcomes are needed.20

References 1. Knaul FM, Farmer PE, Krakauer EL, De Lima L, Bhadelia A, Jiang Kwete X, ArreolaOrnelas H, Gómez-Dantés O, Rodriguez NM, Alleyne GAO, Connor SR, Hunter DJ, Lohman D, Radbruch L, Del Rocío Sáenz Madrigal M, Atun R, Foley KM, Frenk J, Jamison DT, Rajagopal MR; Lancet Commission on Palliative Care and Pain Relief Study Group. Alleviating the access abyss in palliative care and pain relief-an imperative of universal health coverage: the Lancet Commission report. Lancet. 2018 Apr 7;391(10128):1391-1454. doi: 10.1016/S0140-6736(17)32513-8. Epub 2017 Oct 12.

Erratum in: Lancet. 2018 Mar 9;: PMID: 29032993.

2. Radbruch L, De Lima L, Knaul F, Wenk R, Ali Z, Bhatnaghar S, Blanchard C, Bruera E, Buitrago R, Burla C, Callaway M, Munyoro EC, Centeno C, Cleary J, Connor S, Davaasuren O, Downing J, Foley K, Goh C, Gomez-Garcia W, Harding R, Khan QT, Larkin P, Leng M, Luyirika E, Marston J, Moine S, Osman H, Pettus K, Puchalski C, Rajagopal MR, Spence D, Spruijt O, Venkateswaran C, Wee B, Woodruff R, Yong J, Pastrana T. Redefining Palliative Care-A New Consensus-Based Definition. J Pain Symptom Manage. 2020 Oct;60(4):754-764. doi: 10.1016/j.jpainsymman.2020.04.027.

Epub 2020 May 6. PMID: 32387576; PMCID: PMC8096724.

3. Lee YN, Chang SO. How do wound care nurses structure the subjective frame on palliative wound care? A Q-methodology approach. BMC Nurs. 2022 May 17;21(1):119. doi: 10.1186/s12912-022-00900-7. PMID: 35581636; PMCID: PMC9112521.

4. Emmons, K. R., & Lachman, V. D. 2010. J Wound Ostomy Continence Nurs, 37(6), 639-644 5. Probst, S. and Gethin, G. (2021) ‘Skin problems in palliative care’, in Oxford Textbook of Palliative Medicine. S.l.: OXFORD UNIV PRESS. 6. Graves, Marilyn L. MSN, RN, CHPN, CWON; Sun, Virginia PhD, RN Providing Quality Wound Care at the End of Life, Journal of Hospice & Palliative Nursing: April 2013 Volume 15 - Issue 2 - p 66-74 doi: 10.1097/NJH.Ob01331827 edcf0 7. Probst S, Arber A, Faithfull S. Malignant fungating wounds: the meaning of living in an unbounded body. Eur J Oncol Nurs. 2013 Feb;17(1):38-45. doi: 10.1016/ j.ejon.2012.02.001. Epub 2012 Mar 27. PMID: 22459257.

8. Probst S, Arber A, Trojan A, Faithfull S. Caring for a loved one with a malignant fungating wound. Support Care Cancer. 2012 Dec;20(12):3065-70. doi: 10.1007/ s00520-012-1430-y. Epub 2012 Mar 6. PMID: 22391594.

9. Reynolds, H. & Gethin, G. The Psychological Effects of Malignant Fungating Wounds, EWMA 2015 Journal. 2015, 15, 2 29-23.

10. Lo SF, Hayter M, Hu WY, Tai CY, Hsu MY, Li YF. Symptom burden and quality of life in patients with malignant fungating wounds. J Adv Nurs. 2012 Jun;68(6):1312-21. doi: 10.1111/j.1365-2648.2011.05839.x. Epub 2011 Nov 1. PMID: 22043819.

11. Tilley CP, Fu MR, Van Cleve J, Crocilla BL, Comfort CP. Symptoms of Malignant Fungating Wounds and Functional Performance among Patients with Advanced Cancer: An Integrative Review from 2000 to 2019. J Palliat Med. 2020 Jun;23(6):848862. doi: 10.1089/jpm.2019.0617. Epub 2020 Apr 28. PMID: 32349622 12. Woo KY, Krasner DL, Kennedy B, Wardle D, Moir O. Palliative wound care management strategies for palliative patients and their circles of care. Adv Skin Wound Care. 2015 Mar; 28(3):130-40; quiz 140-2. doi: 10.1097/01.

ASW.0000461116.13218.43 13. Marks, L. B., Ten Haken, R. K., & Martel, M. K. (2010). Guest editor’s introduction to QUANTEC: a users guide. International journal of radiation oncology, biology, physics, 76(3 Suppl), $1-52. https://doi.org/10.1016/j.jjrobp.2009.08.075 14. Probst, S. Wound Care Nursing - A Person Centred Approch. 2021 Elsevier London 26] 15. Tsichlakidou A, Govina O, Vasilopoulos G, Kavga A, Vastardi M, Kalemikerakis I. Intervention for symptom management in patients with malignant fungating wounds - a systematic review. J BUON. 2019 May-Jun;24(3):1301-1308. PMID: 31424694 16. Starace, M., Carpanese, M. A., Pampaloni, F., Dika, E., Pileri, A., Rubino, D., Alessandrini, A., Zamagni, C., Baraldi, C., Misciali, C., Patrizi, A., Bianchi, T., Apalla, Z., & Piraccini, B. M. (2022). Management of malignant cutaneous wounds in oncologic patients. Supportive care in cancer: official journal of the Multinational Association of Supportive Care in Cancer, 30(9), 7615-7623.

80

Wound Masterclass - Vol 2 - December 2023

17. Pflibsen, L. R., Lettieri, S. C., Kruger, E. A., Rebecca, A. M., & Teven, C. M. (2020).

Negative Pressure Wound Therapy in Malignancy: Always an Absolute Contraindication?. Plastic and reconstructive surgery. Global open, 8(8), e3007. https://doi.org/10.1097/GOX.0000000000003007 18. Cai, S. S., Gowda, A. U., Alexander, R. H., Silverman, R. P., Goldberg, N. H., & Rasko, Y. M.(2017). Use of negative pressure wound therapy on malignant wounds - a case report and review of literature. International wound journal, 14(4), 661-665. https:// doi.org/10.1111/iwj.12665 19. Akhmetova A, Saliev T, Allan IU, Illsley MJ, Nurgozhin T, Mikhalovsky S. A Comprehensive Review of Topical Odor-Controlling Treatment Options for Chronic Wounds. J Wound Ostomy Continence Nurs. 2016; 43(6):598-609. do: 10.1097/ WON.0000000000000273 20. Gethin, G., Vellinga, A., McIntosh, C., Sezgin, D., Probst, S., Murphy, L., Carr, P., Ivory, J., Cunningham, S., Oommen, A. M., Joshi, L., & French, C. (2023). Systematic review of topical interventions for the management of odour in patients with chronic or malignant fungating wounds. Journal of tissue viability, 32(1), 151-157. https:// doi.org/10.1016/j.jtv.2022.10.007 21. Cost effectiveness analysis: health economic studies. How to use a cost effectiveness analysis to evaluate your digital health product. Office for Health Improvement and Disparities 13 October 2020. https://www.gov.uk/guidance/ costeffectiveness- analysis-health-economic-studies 22. Harding K, Carville k, Chadwick P et al WUWHS Consensus Document: Wound Exudate, effective assessment and management. 2019 23. Velickovic Vet al. Cost-effectiveness analysis of superabsorbent wound dressings in patients with moderate-to-highly exuding leg ulcers in Germany. Int Wound Journal. 2022; 19(2)-447-59. Doi:10.1111/iw.13645 24. https://www.woundsource.com/blog/what-are-superabsorbent-dressings 25. Cochrane Database Syst Rev. 2018: 2018(6): CD012583. Published online 2018 Jun 15. doi: 10.1002/1 4651858. CD012583 pub2 26. Made Easy. Zetuvit Plus Silicone Border. Wounds UK. December 2019. https:// www.woundsinternational.com/resources/details/made-easy-zetuvit-plussiliconeborder 27. Michael W Rich, MD, Robert F. Nease, PhD. Cost-effectiveness Analysis in Clinical Practice. Arch Intern Med. 1999,159(15):1690-1700. doi:10.1001archinte.159.15.1690,August 1999.

28. Velickovic Vet al. Cost-effectiveness of superabsorbent wound dressing versus standard of care in patients with moderate-to- highly exuding leg ulcers. Journal of Wound Care Vol 29, No 4, April 2020.

29. Velickovic Vet al. Cost-effectiveness analysis of superabsorbent wound dressings in patients with moderate-to highly exuding leg ulcers in Germany. Int Wound J. 2021; 1-13. https://doi.org/10.1111/iw13645 30. Velickovic Vet al. Superabsorbent wound dressings versus foams dressings for the management of moderate-to-highly exuding venous leg ulcers in French settings: An early stage model-based economic evaluation. Journal of Tissue Viability, https:// doi org/10.1016/jjtv.2022.04.005 31. Velickovic V, Jankovic D. Challenges around quantifying uncertainty in a holistic approach to hard-to-heal wound management: Health economic perspective. Int Wound I. 2022;1-7, dot: 10.11 11/w.13924 32. Velickovic Vet al. Individualised risk prediction for improved chronic wound management. Advances in Wound Care© Mary Ann Liebert, inc. DOI: 10.1089/ wound 2022 0017 33. Guest JF, Fuller GW, Vowden P. Cohort study evaluating the burden of wounds to the UK’s National Health Service in 2017/2018 update from 2012/2013. BMJ Open 2020,10(12).e045253.

34. Augustin M, Brocatti LK, Rustenbach SJ, Schafer I, Herberger K. Cost-of-illness of leg uicers in the community, Int Wound J 2014,1 1(3) 283-92.

35. National Institute for Health and Clinical Excellence (NICE. Process and methods guides. Guide to the technology appraisal and highly specialised technologies appeal process. London, 2014

woundmasterclass.com/Podcast

How Can A Biodegradable Matrix Offer Limb-Saving Options for Chronic Ischaemia?

Editorial Summary BTM is a dermal matrix that are commonly used in extensive and hard to heal wounds. This dressing adjunct can cover important structures to maintain structural function such as vessels, joint capsules, bone and tendons.

Introduction

C

onsent was gained from the patient to share photo’s in this case study. NovoSorb® Biodegradable Temporising Matrix (BTM) has been studied reasonably extensively in patients with burns, necrotising fasciitis and, more recently, in diabetic foot disease. However, there is a paucity of literature in the setting of tissue loss secondary to chronic limb threatening ischaemia (CLTI).

BTM is a dermal matrix that are commonly used in extensive and hard to heal wounds.

This dressing adjunct can cover important structures to maintain structural function such as vessels, joint capsules, bone and tendons.

This is important in vascular patients to enable them to continue to be mobile avoiding major limb amputation which could then lead to a longer hospital admission and for some, loss of independent living. The matrix is initially placed over the defect to create a neodermis.

Ms Victoria Bristow Vascular Specialist Nurse, Cambridge University Hospitals Cambridge, United Kingdom

82

Our first case using BTM was a 62-year-old male who presented with CLTI and extensive tissue loss involving the dorsum of the foot, multiple toes and the calf. Revascularisation by means of iliacangioplasty and femoral to femoral cross of graft was carried out. Debridement of the foot wasrequired including amputation of 2nd-5th toes. BTM was applied to the dorsum of the foot and the calf. Delamination was carried out at 8 weeks. His wounds were fully healed at 24 weeks.

Wound Masterclass - Vol 2 - December 2023

On presentation to the emergency department, he had extensive necrosis and lower limb ischaemia with only a femoral pulse palpable on the right leg.

When speaking to the patient and his daughter he had presented 3 times at a local district hospital and was misdiagnosed.

He was admitted to the vascular ward for further investigations and revascularisation by the means of a left to right femoral crossover graft using Polytetrafluoroethylene (PTFE) graft.

Figure 1:

How Can A Biodegradable Matrix Offer Limb-Saving Options for Chronic Ischaemia?

“The matrix was applied in theatre under general anaesthesia in full sterile conditions.

With the BTM the wound needs to be able to bleed through the matrix to encourage angiogenesis and create a neodermis.”

Several days later whilst admitted on the ward his toes began to declare themselves and demarcate.

Discussions then began with the team whether his leg was salvageable due to the large area of tissue loss. It was decided that the patient would be discharged home to continue to allow the leg to demarcate.

A consultant colleague and I had recently attended a talk showcasing BTM in burns patients from Australia. These case studies had large areas of tissue loss and it was felt this product would be suitable to the vascular patient group.

The patient was counselled as to this being the first time this product was being used by our centre but was aware due to the large amount of tissue coverage needed the only other option would have been a below knee amputation and the patient was keen to try and salvage his limb.

The matrix was applied in theatre under general anaesthesia in full sterile conditions. With the BTM the wound needs to be able to bleed through the matrix to encourage angiogenesis and create a neodermis. It is secured using staples and negative pressure wound therapy (NPWT) is placed on top this was used for protection and as well as exudate control.

Dressing changes were done weekly for 7 weeks, wound photos were taken and the NPWT was replaced on both the forefoot and posterior calf.

Contraction of the wound was visible. After 7 weeks the graft was delaminated, the staples were removed and the sealing membrane was peeled back. Once removed some slough was present but granulation tissue was present with islands of epithelisation occurring.

Figure 3: 3a

3b

He was reviewed regularly in the outpatient clinic. Sharp debridement was carried out but there was concern that this eschar was covering and protecting important structures including tendons, bone and blood vessels.

Figure 2: 2a

2b

2c

Wound Masterclass - Vol 2 - December 2023

83

How Can A Biodegradable Matrix Offer Limb-Saving Options for Chronic Ischaemia?

“BTM provides a useful adjunct to aid wound healing in revascularised CLTI patients with extensive tissue loss, especially when exposed tendons and bones are present.”

Figure 6:

Figure 4: 4b

4a

6a

6b

Figure 5: 5a

5b

To conclude, we have found that BTM provides a useful adjunct to aid wound healing in revascularised CLTI patients with extensive tissue loss, especially when exposed tendons and bones are present.

Simple dressings were then applied from now on with silver as the primary dressing as per the instruction for use from PolyNovo®. This was carried out by district nurses until week 24 at which the wound had fully healed.

References 1. Novosorb® Biodegradable Temporising Matrix (BTM) and its Applications.

Lim P, et al. Surg Technol Int. 2023. PMID: 37053370 2. Clinical outcomes and resource utilisation in patients with major burns treated with NovoSorb® BTM. Betar N, et al. Burns. 2023. PMID: 37344307 Free article.

3. Long-term scarring outcomes and safety of patients treated with NovoSorbⓇ Biodegradable Temporizing Matrix (BTM): An observational cohort study.

Lo CH, et al. JPRAS Open. 2023. PMID: 37360978 Free PMC article.

4. Treatment of Complex Wounds with NovoSorb® Biodegradable Temporising Matrix (BTM)-A Retrospective Analysis of Clinical Outcomes.

Schlottmann F, et al. J Pers Med. 2022. PMID: 36556223 Free PMC article.

6. Artificial dermal templates: A comparative study of NovoSorb™ Biodegradable Temporising Matrix (BTM) and Integra(®) Dermal Reg 7. Experience with NovoSorb® Biodegradable Temporising Matrix in reconstruction of complex wounds.

Li H, et al. ANZ J Surg. 2021. PMID: 34085755 Free PMC article.

8. Treatment of Necrotizing Fasciitis with NovoSorb® Biodegradable Temporizing Matrix™ and RECELL® Autologous Skin Cell Suspension: A Case Series.

Austin CL, et al. J Burn Care Res. 2023. PMID: 38085950 9. Upper Extremity Wounds Treated with Biodegradable Temporizing Matrix versus CollagenChondroitin Silicone Bilayer.

Wu SS, et al. J Hand Microsurg. 2022. PMID: 38152680 Free PMC article.

10 NovoSorb Biodegradable Temporizing Matrix for Reconstruction of Multiplanar Degloving Injury of the Upper Limb.

Knightly N, et al. Plast Reconstr Surg Glob Open. 2023. PMID: 37020984 Free PMC article.

84

Wound Masterclass - Vol 2 - December 2023

polynovo.com

Supported by

What Is the Role of Platelet-Derived Biologics?

Editorial Summary This article explores the surgical strategy of platelet-derived orthobiologics, providing an overview of the benefits of their use and a consideration of the future of these products.

Introduction

O Prof Anand Pillai Consultant Orthopaedic Foot & Ankle and Adult Reconstruction Surgeon Manchester, United Kingdom

rthobiologics therapies have gained considerable interest in recent years. They are increasingly becoming popular for treatment of a variety of musculoskeletal pathologies. The term ‘biologic’ refers to a naturally occurring substance with the ability to heal, and ‘ortho’ refers to its application in musculoskeletal tissue. They are different from ‘biologic’ drugs commonly used now for treatment of rheumatological conditions.

A wide array of orthobiologics are available but the broad categories of preparations include, but are not limited to: autologous blood products, cell-based therapies, and growth factors. In this article, various autologous blood products and their roles are discussed.1 Autologous blood products refers to any preparation derived from a patient’s whole blood. These include a range of products that can be further categorised into platelet-rich plasma (PRP), platelet poor-plasma (PPP) and autologous anti-inflammatory preparations (AAIs).2 Figure 1: Steps in preparation of PRP and PPP.

Dr Vish Kumar Consultant Orthopaedic Foot and Ankle Surgeon at Wye Valley NHS Trust & Spire Banks Hospital Worcester, United Kingdom

85

Wound Masterclass - Vol 2 - December 2023

As ‘natural’ treatments, these products are an attractive option for both patients and clinicians as they eliminate concerns about immunogenic reactions and disease transmission.

Platelet-rich plasma is a volume of plasma fraction of autologous blood having platelet concentrations above baseline where platelet count is usually 5 times higher than that of blood. PRP was first used to aid wound healing in 1987 after cardiac bypass surgery. It was first used in orthopaedics in 2003 for treatment of recalcitrant tennis elbow.

PRP can be prepared in the laboratory, in the operating theatre or the clinic, from venous blood collected immediately before treatment.

There are 3 techniques for PRP preparation: the gravitational platelet sequestration (GPS) technique, standard cell separators, and autologous selective filtration technology, also referred to as plateletpheresis. A small amount of PRP can be obtained in minutes using the GPS technique which is a table-top centrifuge system. For example, 5 ml of PRP volume can be prepared following a 12 minute spin at 3200 rpm using a GPS system.

What Is the Role of Platelet-Derived Biologics?

“Once the PRP is activated, its advocates suggest benefits including restoration of bone and soft tissue, improved wound healing, and a reduction in post-operative infection and blood loss.”

An anticoagulant such as citrate dextrose (ACD) is added where citrate binds calcium and prevents coagulation, whereas dextrose supports platelet metabolism and viability.

PRP is stable in the anticoagulated state for 8 hours or longer allowing the blood to be drawn before the operation and used as needed during long surgical procedures. Once PRP is prepared, it must be activated for platelets to release its granules bioactive contents. This is usually accomplished by adding a small amount of topical bovine thrombin and 10% calcium chloride to the PRP.2 Once the PRP is activated, its advocates suggest benefits including restoration of bone and soft tissue, improved wound healing, and a reduction in post-operative infection and blood loss. There has been several publications on the use of PRP for clinical applications in plastic surgery, oral surgery, trauma and orthopaedic surgery, spinal fusion surgery, heart bypass surgery and in the treatment of chronic skin and soft-tissue ulcers.4,5 PRP preparations can be further subdivided into leucocyte-poor preparations (LP-PRP; defined as having a leucocyte concentration below baseline) and leucocyte rich preparations (LR-PRP; defined as having a leucocyte concentration above baseline.

Autologous Anti-inflammatories Preparations (AAIs) With an increasing appreciation that many of the anti-inflammatory factors within blood arise from leucocytes rather than platelets, strategies focussing on concentrating leucocytes or the anti-inflammatory factors they release have been developed. These include platelet-poor plasma (PPP) and AAIs. AAI formulations include Autologous Protein Solution (APS) (nStride) and Autologousconditioned serum ACS (known as Orthokine

in Europe and Regenokine in the US). APS is an AAI that has supraphysiological concentrations of anti-inflammatory factor ILr. APS is produced by obtaining LR-PRP, which is then filtered through polyacrylamide beads producing a high concentration of anti-inflammatory cytokines while ensuring low levels of pro-inflammatory contents.

ACS is another AAI which is a cell free serum containing anti-inflammatory factors released from activated leucocytes. ACS is obtained by drawing whole blood and incubating this with chromium sulphate to stimulate the synthesis of interleukin-1 (IL-1) receptor antagonists and other anti-inflammatory cytokines. This then undergoes filtration and centrifugation prior to intra-articular injections to treat osteoarthritic conditions such as knee OA.1

Biological Properties and Activities of PRP Platelets are the smallest of the blood cells, approximately 2 μm in diameter. Theirα granules contain more than 30 bioactive proteins such as Platelet Derived Growth factor (PDGF), Transforming Growth Factors-Beta (TGF-B), Vascular Endothelial Growth Factors (VEGF), among others. These proteins have a fundamental role in haemostasis and tissue healing. The biological properties of PRP are based on the production and release of these multiple growth and differentiation factors when the platelets are activated. Platelets actively begin secreting these proteins within 10 minutes of clotting. Healing of both soft and hard tissue is mediated by a complex array of intra- and extra- cellular events that are regulated by these signaling proteins.5

Safety Profile of PRP PRP preparations are generally safe. However, activation of PRP requires bovine thrombin preparations which has some concerns related to coagulopathies, especially when used in large

Wound Masterclass - Vol 2 - December 2023

86

What Is the Role of Platelet-Derived Biologics? amounts.

Table 1: Broad categories of Autologous blood products.

Autologous blood products

Platelet rich plasma (PRP)

Autologous antiinflammatories (AAIs)

PRP subdivisions

Commercially available separator devices

Leucocyte poorPRP (LP-PRP)

ACP, Arthrex A-PRP, Regenlab Cascade, MTF clearPRP, Harvest PurePRP, EmCyte Endoret (PGRF0, BTI

Leucocyte richPRP (LR-PRP)

GPSIII, ZimmerBiomet Angel, Arthrex GenesisCS, EmCyte Magellan, Arteriocyte, SMART PReP, Harvest

Autologous Protein Solution (APS)

nStride, ZimmerBiomet

Autologous Conditioned Serum (ACS)

Orthokine, Orthogen

In the UK, PRP is classed as an unlicensed human medicine. Therefore, it is subject to human medicines legislation. Recently, there have been some concerns in relation to its unregulated widespread use, so much so that it has come under scrutiny by some professional bodies. The Royal College of Podiatry (RCPod) is instructing its members to stop providing platelet-rich plasma (PRP) therapy to patients with immediate effect; the RCPod is instructing any members who undertake PRP injections to suspend their use while an urgent review of information from the Medical Healthcare Regulatory Authority (MHRA) takes place.6 It is recommended any clinician offering PRP therapy should do so within a clinical governance framework.

Global Market of PRP Despite the lack of sound evidence use of PRP is increasing. The global platelet rich plasma (PRP) market size was valued at USD 627.9 million in 2022 and is expected to grow at a compound annual growth rate of 15% from 2023 to 2030.

Platelet-rich plasma usage is witnessing growth owing to the increasing participation in sporting events leading to increasing cases of sports injuries, and an upsurge in cosmetic surgery.

87

Wound Masterclass - Vol 2 - December 2023

Increasing research applications of platelet rich plasma (PRP) are also fuelling the industry growth. The growth of PRP treatment in the upcoming years may involve treating the large geriatric population, and in dental health.

For instance, in 2020, according to the American Society of Plastic Surgeons, a 25% rise in the use of PRP in cosmetics was observed in the last 4 years.7

Conclusion Orthobiologics and regenerative therapies, particularly PRP, represents an exciting field with multiple potential uses. However, many products with different trade names and descriptions continue to be introduced making the terminology and nomenclature of these therapies ambiguous and difficult to follow. More research trials with linked clinical registries and biospecimen repositories are needed to standardize and substantiate its continued future use.

References 1. Toland GE, Makaram NS, Atzmon R et al. Orthobiologics in the knee. Orthopaedics and Trauma 37:3, 2023.

2. Murray IR SM, De Bari C, McCaskie AW. Orthobiologics: scientific background. J Trauma Orthop 2022;10:48-9As ‘Natural’ treatments, attractive option for both patients and Surgeons/ Clinicians 3. J Alsousou , M Thompson, P Hulley, A Noble, K Willett. The biology of platelet-rich plasma and its application in trauma and orthopaedic surgery: a review of the literature. J Bone Joint Surg Br. 2009 Aug; 91(8):987-96.

4. Kumar V, Millar T, Murphy PN, Clough T. The treatment of intractable plantar fasciitis with platelet-rich plasma injection. Foot (Edinb). 2013 Jun-Sep; 23(2-3):74-7.

5. Eppley BL, Pietrzak WS, Blanton M. Platelet-rich plasma: a review of biology and applications in plastic surgery. Plast Reconstr Surg. 2006 Nov;118(6):147e-159e.

6. RCPod tells its members to stop providing PRP injections. Royal College of Podiatry.

Available at: https://rcpod.org.uk/news/rcpod-tells-its-members-to-stop-providing-prpinjections. [Accessed on 17th June 2023].

7. Platelet Rich Plasma (PRP) Market Size, Share & Trends Analysis Report By Type (Pure, Leukocyte Rich), By Application (Orthopedics, Sports Medicine, Cosmetic Surgery), By End-use, By Region, And Segment Forecasts, 2023 - 2030. Grand View Research. Available at: https://www.grandviewresearch.com/industry-analysis/platelet-rich-plasma-prp-market.

[Accessed on 16 June 2023].

MasterSeries 60 Minutes Interactive All Roads Lead to Healing: Mastering Wound Bed Preparation

from providing services to those not likely to

Global expert

benefit – avoiding under use and misuse

Ms Terry Swanson Vice Chair, International Wound Infection Institute

•

Patient centered: Providing care that is respectful of

Victoria, Australia

and

responsive

to

individual

patients’

preferences, needs and values and ensuring that patient values guide all clinical decisions

Global expert Prof Georgina Gethin

•

Professor of Nursing, Head of School of Nursing and Midwifery, University of Galway

Timely: Reducing wait and sometimes harmful delays for both those who receive and those who give care

Galway, Ireland

•

Person Centeredness and Combining It With Wound Bed Care

Efficient: Avoiding waste, including waste of equipment, supplies, energy, and ideas

• What Is Quality in Healthcare?

Equitable: Providing care that does not vary in quality because of personal characteristics such as gender, ethnicity, geographic location, and

In the US, the agency for healthcare research and

socioeconomic status

quality identifies six domains that are considered 1

to be indicators of health care quality. With the application of this with wound care, patients can

•

The key symptoms and experiences associated with a chronic wound

experience high quality and consistent treatment, aiding to their satisfaction and wellbeing during the

This can be divided up into three categories: physical

process of their care.

impact, social impact, and psychological impact.

These are all integrated within the person-centred

Care being provided should be:

Supported by

•

Safe: Avoiding harm to patients from the care that is intended to help them

•

Effective: Providing services based on scientific knowledge to all who could benefit, and refrain

88

Wound Masterclass - Vol 2 - December 2023

care.2

MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation

“The notion of person-centred care offers a vital perspective that patients should be at the centre of decisions made, rather than on the periphery. Clinicians with such wider perspectives will enhance the quality of care for their patients.”

•

Figure 1: interconnected themes of patient impact.

Adherence: Decision to accept, reject or modify their treatment

•

Concordance: Agreement between a clinician and patient on the treatment plan

In comparison to other concepts, such as compliance adherence and concordance, person centred care holds 8 principles, as identified by the Picker Institute at Harvard Medical school. Although not defined as an academic research or set out as policy, the principles had been defined via consultation with the public.

These include: •

Continuity and transition

•

Access to care

•

Information and education

•

Respect of patient’s preferences

•

Physical comfort

The notion of person-centred care offers a vital

•

Involvement of family and friends

perspective that patients should be at the centre

•

Emotional support

of decisions made, rather than on the periphery.

•

Co-ordination and integration of care

Clinicians with such wider perspectives will enhance The examination of these decided principles in relation

the quality of care for their patients.

to wound care is important for better treatment and The World Health Organisation (2015) described

care. In regard to access to care, it can be considered

person-centred care as “a paradigm shift toward

for patients with recurrent wounds - such as venous

an approach where people have the education and

leg ulcers or hidradenitis suppurativa - as they know

support, they need to make decisions and participate

when a wound is about to break out, or the early signs

in their own care”.

of it about to, they may become more impatient with the idea of being added to a waiting list, wanting more

Support may consist of social, health service or financial

support.

This

description

from

prompt access the care they require at that time.

WHO

emphasises that it is based on people’s needs and

Information and education in an appropriate format

expectations, rather than a focus on diseases. The

which patients can understand and access freely

approaches and practices that consider the person

is equally important. Evidence shows that current

as a whole, with many levels of needs and goals,

resources for wound care are not widespread and

with these needs coming from their own personal

readily available. The European Wound Management

social determinates of health. Whilst this is a very

Association are contributing to this by providing more

thorough and tasking approach, clinicians can use

patient education.

this approach to improve the wellbeing and results for their patients.

Co-ordination and integration of care can look to the analysis of medical records, for example. It is

•

Compliance: Willingness to follow or consent to

possible for there to be separate medical records

the wishes of another

depending on departments such as dermatology, GP practice, hospital practices, etc. This may include

Wound Masterclass - Vol 2 - December 2023

89

MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation

“A wound can be thought of as like an island. An island is affected by what is surrounding it, and under it.”

the continuity of care and transition arrangements.

•

In each study, it was identified that patients

A various set of notes requires coordination and for

with chronic wounds had poorer mental health

it to be integrated properly for the patient. Wound

than their age/ gender counterparts. This was

care practitioners must also be aware of the sensitive nature of analysing these notes - a patient can find

achieved with different measuring scales •

looking at such material to be distressing as they are

99% could walk unaided, serving to be beneficial as mobility and exercise is a factor to promote

not used to seeing it like an experienced clinician is.

healing

Involvement of family and friends regards emotional

•

53% have hypertension (EU)

support,

•

16-20% have diabetes3

but

may

also

include

educational,

appointment arrangements. Physical comfort may be achieved with beds, appliances, and suitable

A group of patients with chronic wounds and the topic

compression wear.

of wound assessment heavily regards looking at a group of individuals with complex health care needs.

European Wound Management Association have

Fit and healthy people do not get chronic wounds;

further evidence for person centred care for chronic

there is one fundamental underlying comorbidity, and

wounds.

at least one underlying factor that is affecting healing.

Furthermore, prescribed medications, environmental

Also, impact of patient health and lifestyle factors on

factors, and age, etc.

wound healing: The Island Paradigm •

Stress

•

Sleep

A wound can be thought of as like an island. An island

•

Smoking

is affected by what is surrounding it, and under it.

•

Alcohol

When looking at wound assessment, it can be broken

•

Common medication and illicit drug use

down into further parts:

•

Physical activity

•

Nutrition Figure 2: Holistic approach to wound assessment.

These are the most prevalent risk factors.

The Profile of Patients With Venous Leg Ulcers: A Systemic Review and Global Perspective Evidence taken from multiple sources of data produced these key findings on patients with venous leg ulcers complied into a picture of the population we are dealing with: •

Age 47 (Asia)

•

Age 69 (EU)

•

Ulcer size is on average 25.7cm^2 (EU)

•

To 30.95cm^2 (South America)

•

Mean ulcer duration = 13.8 months (EU)

•

To 65.5 months (South America) - Longer, arguably due to various different resources and the structure of services

90

Wound Masterclass - Vol 2 - December 2023

MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation

“Many clinicians now begin consultations in a different way, ensuring that patient centred concerns are emphasised. This is expressed via questions asking the patient of their concerns, specific care requests, and establishes a focus on what the patient would like to assess, rather than creating one sided medical goals from a practitioner.”

All of these factors will influence what the wound

6. Assess for treatment infection.

looks like, as well as altering the rates of healing and the risk of further deterioration.

7. Moisture management.

Preparing the Wound to Heal

8. Evaluate rate of healing.

This approach4 looks at wound bed preparation in

9. Edge effect:

terms of updated recommendations. It is shown to be effective as it begins with a person with a chronic

Regards looking at the edge of the wound to indicate

wound, focusing on the patient immediately with

wound status.

this person-centred care approach. Secondly, it looks to identify/ treat the cause of the wound and

10. Organisational support.

identify the patient and family’s centre of concern.

Thirdly, determine the ability to heal, before moving

Wound assessment helps to plan treatment, monitor,

on to looking at local wound care. This may include

and evaluate, justify interventions, and in terms of

debridement, inflammation/ local infection, and

enhanced communication.

moisture balance.

Wound bed assessment is fraught with a longThe approach suggests ten recommendations for

standing difficulty of it being primarily subjective.

clinicians to instil in their practices:

This is due to the fact it consists of visual inspection and relying on descriptors to help clinicians identify a

1. Treatment of cause:

wound. There are very few objective methods. More of the interventions in wound assessments require

It is important to identify the cause and to treat

technology, and this requires more finance and

it. This may be pressure, moisture associated skin

resources that may not be accessible to everyone.

damage, medical device related injuries, or venous hypertension.

The triangle of wound assessment5 involves analysing three aspects of the wound:

2. Patient centred concerns: •

Wound bed

Many clinicians now begin consultations in a different

Tissue type

way, ensuring that patient centred concerns are

Exudate

emphasised. This is expressed via questions asking the patient of their concerns, specific care requests,

Infection •

Wound edge

and establishes a focus on what the patient would

Maceration

like to assess, rather than creating one sided medical

Dehydration

goals from a practitioner.

Undermining Rolled

3. Determine ability to heal:

•

Periwound skin Macerating

This aspect questions whether is it possible for a

Excoriation

wound to heal or not.

Dry skin Hyperkeratosis

4. Local wound care

Callus Eczema

5. Debride when indicated

Wound Masterclass - Vol 2 - December 2023

91

MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation

“Wound bed assessment is fraught with a long-standing difficulty of it being primarily subjective. This is due to the fact it consists of visual inspection and relying on descriptors to help clinicians identify a wound.”

Figure 3:

Figure 4:

Figure 5:

Figure 6:

Figure 7:

Figure 8:

With the wound blocked out in Figure 3, the

By contrast, Figure 5 shows a heel wound from a

surrounding of it can be made clearer. Doing so will

patient with diabetes and history of stroke. There

improve judgement of what the wound is likely to be.

are no areas of surrounding erythema, no signs of infection despite the build-up of thick tenacious

There is dry flaky skin build up, varicose eczema and

slough. The wound presents a well-defined edge,

dryness from prolonged bandaging. There is also

alongside healthy tissue that is merging into the

a fragile periwound area, combined with satellite

wound.

lesions and varicosities. This patient has venous hypertension, long-standing venous leg ulceration.

In a case like Figure 5, the treatment should aim to protect the good tissue that is there via the form of

Figure 4 reveals the wound. In looking into this and

granulation tissue around the top. Removal of slough

assessing the edge of the wound, the potential of

is not recommended at this point. As this patient has

healing can be decided. The edge blending into the

severe peripheral arterial disease, removing slough

wound and lack of definition, alongside the wound

via a scalpel would cause a new wound to open up,

bed itself showing fibrous and bright red friable

causing a rebound necrosis. The primary aim with

tissue, shows there is potential for healing, however

this wound would be to manage the exudate, protect

it requires a renewed approach. A healing wound

underlying tissue, and monitor any signs of infection.

would hold a more defined edge, with areas showing epithelial edge advancement. This is not evident in

Figure 6 presents a different kind of wound edge.

this particular wound.

It holds a purple hue on its surroundings, with a dark dull red. The issue of colour is shown here as a bright red indicates a good red granulation tissue;

92

Wound Masterclass - Vol 2 - December 2023

MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation

“Adequate wound cleansing is vital for all wound cases. Utilisation of a good irrigation fluid to cleanse the wound, and potentially drinkable regular tap water, will aid in the healing process.”

Figure 9: Periwound assessment.

take a long time. In this patient, the likelihood of healing is very small, primarily due to many social circumstances, but due to multiple underlying comorbidities.

The wound edge shows a highly fragile and friable state. Underneath it, there is a delicate and inflamed tissue, beside areas of epithelial that are popping up indicating that healing is occurring. However, there is a large build-up of pseudemonas, maceration and inflammation. There is copious exudate from the wound that is pouring down and gathering around the ankle.

description can become problematic. Figure 6 is red, however as it is a dull red it is a poor indication. The

Treatment would be to treat underlying infection,

entire wound is covered in fibrous tissue, but it is not

irrigation to reduce bacterial burden, as well as extra

slough. The edge is ragged and also very thin.

moisture absorbing dressings around the ankle with protection of the periwound area. Regular wound

This patient has rheumatoid arthritis. With flare

dressings would also be required. Changing absorbent

ups, the wound would become enlarged. Here, the

pads to soak up exudate would be beneficial. The

deterioration is due to rheumatoid arthritis and drug

patient in Figure 8 refuses compression therapy

therapy the patient was undergoing.

despite being eligible for it.

The wound is a healable wound and can be managed

Wound edge assessment in Figure 8 shows a very

by managing exudate from the wound, managing

varied result. This evidence supports the fact that

inflammation around the wound, and managing local

a challenge in wound care includes the fact that a

wound infection.

wound is not a uniformed island and is different depending on the focus point of the wound.

Figure 7 presents a patient with a common kind of venous leg ulcer. There are no signs of infection or

Figure 9 clearly illustrates an infected wound, with a

inflammation around the wound. The wound bed

large maceration of periwound skin due to excessive

itself presents bubbly like granulation tissue – ideal

moisture from the wound. There is also a build-up

tissue accompanied with a well-defined wound edge

of slough, surrounded by a friable edge that is not

that is not inflamed nor slopping into the wound itself.

defined but inflamed.

There is some fibrous tissue, however no build-up of slough. Management of a simple dressing to protect

In this case, gentle irrigation to clean the wound

the tissue combined with a management of wound

bed and reduce the bacterial burden, high quality

exudate would be ideal.

protection of the periwound skin, and adequate moisture control would be sufficient for management.

Adequate wound cleansing is vital for all wound cases.

Compression therapy should be held off until the

Utilisation of a good irrigation fluid to cleanse the

infection has been resolved.

wound, and potentially drinkable regular tap water, will aid in the healing process.

Figure 8 presents a highly extensive venous leg ulceration. It is a healable wound; however, it may

Wound Masterclass - Vol 2 - December 2023

93

MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation In regard to protecting the peri wound area it is

The human microbiome is a complex system. On some

important to:

occasions the microbiome works together to reduce pathogenic bacteria - not all biofilms are necessarily

• •

Protect it from Moisture Associated Skin Damage

bad. This is only the case when it becomes pathogenic

(MASD)

and subsequently forming hyperinflammation leading

Cleanse

with

hypoallergenic

non

irritating

to a chronic and recant wound healing process.

products •

Avoid

products

containing

preservatives,

This shows an imbalance where there are too many

quinoline, PVP iodine

negative components that are not conducive to

•

Tepid water only if used

wound healing, and such destructive enzymes and

•

Opt for the utilisation of no rinse products

toxics can worsen the wound condition. It causes

•

Gently dry the skin

for the wound to change from being host centric -

•

Carefully consider wound dressings

controlled by the body’s physiological processes - to

•

Use skin protectant products

now more bacteria centric. This imbalance decreases the amount of growth factors. Additionally, the

To conclude, wound bed preparation involves

destructive lytic enzymes and free radicals affect cell

patient assessment, assessment of the aetiology

proliferation and wound healing capability.

of the wound, healing assessment, and wound bed assessment.

The

nutrient

rich

exudate

from

persistent

inflammation assists in the bacterial cause and makes

Wound Bed Preparation

that environment more hostile, therefore affecting immune recognition and the healing process.

Principles of Biofilm Management Biofilm Consensus Group 2017 findings Planktonic is not the normal state for bacteria. It is considered as non-attached, free floating and

In a consensus group from 2017, signs and symptoms

replicating. It goes into great density/ virulence and

were established:

becomes an acute infection. Antibiotics are effective for planktonic because they are replicating.

•

Failure of appropriate antibiotic treatment

•

Recalcitrance

themselves, to the dressing, or below the wound

to

appropriate

antimicrobial

treatment

Biofilm is when they attach; they can attach to •

Antibiotics do not function on non-replicating bacteria. Biofilm decreases myotic activity

surface. When they become attached, they can aggregate. Aggregation can enable communication known as quorum sensing.

•

When they begin to mature, they become more

•

Recurrence of delayed healing on cessation of antibiotic treatment Patients with local infection or biofilm infection

tolerant to most antimicrobial agents. The host

are often on a 10-week cycle, in which once the

defences’ efficacy becomes reduced due to the

antibiotic treatment has stopped, symptoms

protection of the extracellular matrix because the

come back rapidly

centre of a mature biofilm may be slightly hypoxic, and the myotic activity – replicating – has decreased.

•

Delayed

healing

despite

optimal

wound

management and health support

Therefore, antibiotics would not become effective.

•

Describes when a patient has a healable wound

The body recognises that the biofilm is there, and

but delayed healing despite optimal treatment –

therefore it promotes a chronic inflammation.

diagnosis and targeted therapy

Evidence shows that it can be over 1000x more tolerant to antibiotics. Biofilms have primitive

•

Increased exudate/ moisture

circulatory systems that facilitate uptake of nutrients

(when) doing weekly assessments, an increase in

and removal of metabolic products. These nutrients

moisture is a negative indicator

can be from edema and fluids, hence why moisture

94

management is vital. This causes an increase of

•

Low-level chronic inflammation

exudate when there is a biofilm.

•

Low-level erythema

•

Patients

may

sometimes

be

prescribed

There can also be gene transfer of microbes within

antibiotics despite it being an inflammation

the biofilm, and this may be polymicrobial.

instead of an infection

Wound Masterclass - Vol 2 - December 2023

MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation •

Poor granulation/friable/hyper granulation

•

Secondary signs of infection

Figure 10:

Figure 10 shows an updated version of biofilm based wound care. It upholds consistent instructions of the disruption of the biofilm and the prevention of recolonisation. With this scheme, the signs of persistent inflammation must be monitored.

Presence of slough and necrosis may not necessarily be relevant to biofilm, as it may be a result of other things such as circulation (for necrosis) and moisture balance (for slough).

Management of Biofilm: Common Ingredients •

Knowing aetiology

•

Standard of care for that aetiology

The International Wound Infection Institute (IWII)

•

Wound and periwound cleansing.

coined the term ‘wound hygiene’. It was expanded

•

Debridement of wound, edges and periwound

and explored on within the document, providing a

•

Once the wound is prepared then proactive

consensus of what wound hygiene entails. It involves

management to prevent microbial attachment

an anti-biofilm strategy: what to look out for, and how to handle the intensity of those interventions.

Consistency in the recommendations of biofilm: Outline of Wound Hygiene •

WBP – Wound Bed Preparation, since 1990s.

•

Time –since early 2000

1.

Cleanse the wound and periwound skin

•

BBWC - Biofilm based wound care

2.

Debridement

•

Step-down step-up paradigm – published 2017

3.

Refashion the wound edge

•

Wound Hygiene – published 2019

4.

Dress the wound

These documents provide a synthesis of the latest

The wound hygiene concept has continued to evolve;

research and evidence. They are also patient

it began with the wound itself and continued to

centered, and when adapted locally they can provide

expand. The wound healing framework includes

cultural sensitivity and awareness.

assessment, management of the wound via the four steps of wound hygiene, and monitoring to ensure

As they are reviewed and authored by clinicians

the cycle of healing continues.

for clinicians the majority are free for download or feature a low fee requirement to increase

The

accessibility. Additionally, they can be translated into

contamination,

many different languages.

spreading infection and systemic. Due to the usage

wound

infection

continuum

colonization,

consists

localised

of

infection,

of the term ‘critical colonization’ in 2008, localised has Using evidence-based practices in documents can

become asterisked.

be highly beneficial due to the issues presented by disparity in how people are managing wound

The continuum became updated in 2016 via rigorous

bed cleansing globally. As there is varied practice

methodology. Figure 11 displays this version, with

throughout the world, these documents detailing best

terminology about increasing microbial virulence in

practice and guidelines provide a helpful framework

green, and there is also a biofilm arrow included at

for people to be apply to their own clinical practices.

the top.

They may also be used to update policies and

The intervention strategy developed with changes to

procedures; accrediting the clinic with higher quality

reserve topical anti-microbials for when there is a local

references and data as the latest evidence is being

infection, as well as saving systemic antimicrobials.

implemented.

The term critical colonization had been removed, saving

systemic

antimicrobials

for

spreading/

Wound Masterclass - Vol 2 - December 2023

95

MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation Figure 11:

Figure 12:

Figure 13: Evaluation of an infected wound.

systemic infection. This enables good stewardship of antiseptics and antimicrobials.

The wound infection continuum became updated further in 2022 (Figure 12), again via rigorous methodology.

This

edition

features

signs

and

symptoms under the relevant terminology.

Local Infection: Infection Contained within the Wound Bed Covert, also known as Secondary S&S infection: •

Delayed healing or increased size of wound

•

Unhealthy granulation tissue

•

Increased Exudate

•

Suspected Biofilm

Overt, Classic S&S infection:

Spreading Infection, the invasion of surrounding and deeper tissue by ineffective organisms:

•

Erythema within 2 cm

•

Purulent exudate

•

Increasing pain

•

Local warmth and oedema

•

Erythema becomes greater than 2 cm, as shown in Figure 13

•

Cellulitis

•

Lymphangitis

•

Enlargement of the wound and/or satellite ulcers

Covert is aligned with the biofilm and the secondary signs of infection such as delayed healing, increased

Treatment would not solely consist of therapeutic

wound size, and unhealthy granulation tissue.

cleansing and topical antimicrobials, but also includes systemic antibiotics.

Overt are the classic signs of infection, including increased pain, oedema, and there may be some exudate. It is important to note that this is still contained within the wound bed.

Treatment is proactive as it involves therapeutic cleansing and consideration of topical antimicrobials.

96

Wound Masterclass - Vol 2 - December 2023

MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation Figure 14: Determining infection vs induration of a wound.

edges to prevent the microbes that are on the periwound surface returning to contaminate the wound.

The intensity depends on the healing phase and condition the wound is in.

The importance of wound cleansing: •

Decreased antibiotics prescribing

•

Alteration of wound environment

•

Disruption of biofilm

•

Improved efficacy of topical treatments

•

Prevention of escalating from local infection to spreading of infection (when conducted in early phases of wounding)

•

Maybe saving a limb or life

It is vital to ensure that when doing therapeutic irrigation that there are the correct pounds per square inch of 4-15 psi. With loose or necrotic tissues, a higher psi would be required, and it may be lowered once it is clean or healing. Therapeutic irrigation must be carried out with personal protection.7,8 Options for cleaning the periwound and skin: •

Portable water and wash cloths

•

Commercial wipes - often used in podiatry

A challenge presented in wound care is the confusion

department due to its smaller body surface

between infection and inflammation. Figure 14

•

Glove fingers

presents an inflamed wound that may be caused

•

Forceps

from contact with the dressing and a reaction, or it

-

often

used

for

scraping

off

hyperkeratotic tissue

may be the wound fluid that is now interacting with

•

Sponges

the skin in a negative way causing contact dermatitis.

•

Utilisations of cleaning agents – provides

By understanding the cause, the difference can be

synergistic effects that are highly beneficial6

made better.

Tips for Practice When cleansing wounds, it is effective to adopt a thorough and comprehensive approach. It is possible

•

to remove non-viable tissue and clean it up to enable the dressings to directly contact the wound surface

the periwound •

and perform better. Once the biofilm and micro

Don’t contaminate the water. If using a bowl of warm water, do not put the cloth that touched

environment has been disrupted, the dressings have better access.

You can be soaking the wound while you clean

the skin back into the water •

You can apply pH neutral/ antiseptic skin cleanser on gloved hands, massaging it in and

Helpful Tips for Therapeutic Wound Cleansing

then washing with potable water •

The patient can shower but the limb should be

When deciding what to cleanse with, it ultimately

bagged first, and then cleaned. This allows for

depends on what is there available, as well as the

the limb to be protected from the contaminates

type of wound – such as healing or infected. Infected

and microbes from the upper body

wounds can use antiseptics as its design is for this purpose. Cleaning occurs with each dressing change,

In the event the patient has a very dry scaly leg, it may

and anywhere there has been a dressing. This area

be the case that the leg has dried up after removing

should be cleansed about 20 cm from the wound

the compression wrap.

Wound Masterclass - Vol 2 - December 2023

97

MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation A good method to handle dry scaly wounds is as

its full potential of healing by being cleansed.

follows: A common misconception is that there is a difference • •

Create a soak by pouring solution on the wound,

between mechanical cleansing and debridement.

this provides it with contact time

However, they are essentially the same thing; both

Using gloves and with a combination of a pH skin

methods achieve the same goal. The components

cleanser, massaging the wound helps soften the

illustrated here may also be sued to be applied to

skin

negative pressure wound therapy.

Prevention is highly important in wound care to

Figure 15: Types of wound exudate.

ensure the wound does not become worse. Wound cleansing should also be combined with protecting limb skin health. The Management of Hyperkeratosis of provides easy strategies for cleansing and providing emollients. Hyperkeratosis is essentially a breeding ground for microbes and the goal is to reduce this to

Serous

Seroanguineous

Sanguineous

Seropurulent

Fibrinous

Purulent

Haemopurulent

Haemorrhagic

prevent infection.

Rinsing, cleaning, or scrubbing a wound: It is important to clean a wound, and if it is an infection it would need to be scrubbed. In order for this to happen the synergistic effect and combination of an agent and mechanical device would be needed.

•

Sterile water and normal saline have limited ability to manage microbes. If this is the only resource available, it is important to combine

•

•

•

•

this with more aggressive mechanical action

Figure 15 displays the different types of exudate. In

Antiseptic solutions assist in making the cleaning

regard to the viscosity, understanding the viscosity/

more effective. They can kill and or disrupt the

consistency can influence the effectiveness of

bacteria in the wound

dressings.

Surfactants make the job easier and more effective due to the fact it breaks surface tension

It is also beneficial to inspect the old dressings and find

and makes removing debris more effective

out when it was last changed. A dressing saturated in

Using mechanical aids improves the goal of

a matter of hours will not last for three days. This can

the activity. Using gauze is acceptable but

help decide the frequency of wound dressing change,

multiple would need to be used to prevent cross

or the absorbency of the dressing. Moisture needs to

contamination

be balanced, and the type of fluid and dressing used

Therapeutic cleansing is rigorous cleansing of

will aid in wound assessment.

wounds and periwound to remove: Assessing the Wound Exudate • •

Excess exudate, debris, remnant dressing, nonviable tissue

•

Inspect the used dressing for any leakage

Improve assessment, as components of the

•

Determine the amount of wound exudate in

wound are defined more clearly •

Disrupt and remove microorganisms

•

Wound cleansing should be done with each

both wound and dressing •

Assess the colour, viscosity, and odour of wound exudate

dressing change When managing and treating infection, it is important During this process it is important to be aware of the

to be mindful about prescribing antibiotics due to

fact that some cultures do not advocate cleansing.

antimicrobial wounds. It is still necessary to carry out

Due to the importance of cleansing, it is imperative

wound preparation even when prescribing antibiotics.

to teach the patients why it is needed and to have

The five-step guide to wound healing suggests key

cultural sensitivity. This can be done by proving the

warning signs including:

evidence and conveying how the wound needs to have

98

Wound Masterclass - Vol 2 - December 2023

MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation •

A healable wound is not healing

delayed by external clinicians until the wound has

•

Changes to the patient’s overall health or

significantly worsened:

wellbeing (fever, etc.)

•

Increased amounts of exudate, discoloration,

•

odour

Incorrect

diagnosis,

and

requirement

for

specialised clinics

•

Deterioration of wound edge or periwound skin

•

Requirement for advanced therapy

•

Hyper-granulation - discolouration of the wound

•

Growth factors

bed, granulation tissue, fragile wound bed tissue •

Biofilm should be suspected if a local infection

When wounds are not healing, or it is being

is

significantly delayed, clinicians can act as a facilitator

non-responsive

to

topical

antimicrobial

treatment

of advanced care, and work with other specialists to achieve the end goal. This may involve dieticians,

The classification system from the IWGDFU can be

podiatrists, and vascular surgeons. Sharing the

mirrored with the IWII classification system to portray

workload and collaborating will ensure the patient

consistent information and resources. This evidence

is provided with well-rounded specialised care for

shows how accurate resources and information are

optimal results. Moving towards a multidisciplinary

highly important to ensure clinicians follow a well-

clinic can provide high benefits for patients appearing

established routine.

with non healing wounds.

Why are wounds therapeutically cleansed?

As the healing trajectory becomes closer, more gentle methods can be adopted, and the need for sharp

•

To disrupt the biofilm

•

To cleanse excess exudate from the wound

•

To prepare the wound bed for cultures and/or

This biofilm suppression process, as established by

the wound dressing

Stephen Percival (2022), provides a process of how

•

To assist in wound assessment

to remove biofilms, similar to the existing concept

•

Removing debris, foreign bodies, remnant

therefore showing the great consistency between

dressing, and loose non-viable tissue

resources to enable high quality care over different

To decrease the bioburden

clinics.

•

selective reduce.

The ‘Step Down Step Up’ biofilm based wound care

It is important to note that sharp debridement

strategy places importance on the requirement to be

alone cannot solely achieve biofilm suppression.

less tolerant of non-healing wounds.

Cleansing is still necessary, as well as a repetition of debridement- depending on the depth of the biofilm

It is important to understand what the diagnosis is. If

below the surface level.9

this is unclear it is necessary to carry out a referral or use a clinicians that can provide this diagnosis.

Antimicrobial

Aggressive debridement and empirical treatment, as

Antimicrobial is an umbrella term used for antibiotics,

well as a standard of care should be implemented. In

antiseptics, and disinfectants.

doing so, the first week should enable an improved quality of living for the patient, such as decreased

•

Antibiotics

are

selective

agents

against

exudate and decreased odour. Whilst wound healing

replicating bacteria to kill or reduce them. It can

may not necessarily occur yet, a healing trajectory

be administered systemically or topically. With

should be established within the first month.

biofilms, there is a decreased activity of this, hence why they are not effective

With an expected healing timeline formed, the choice

•

Antiseptics are chemical agents that can be

to step them down to standard care could be made,

applied topically to a skin or wound. The new

or potentially step them up for more advanced

generation of antiseptics have low cytotoxicity

therapy options, as shown in the graph. With early

and selectivity. They are designed to inhibit and

intervention, this process is made possible.

kill the multiplication of microorganisms •

Disinfectants are not used on human wounds as

In cases where a wound does not benefit from this

they are toxic to human cells. However, they are

process or early intervention, it must be reassessed.

used to surfaces prior to putting equipment on

This also involves cases in which the diagnosis was

top. They are relatively non-selective agents with

Wound Masterclass - Vol 2 - December 2023

99

MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation multiple sites of actions that kill a wide range of

•

Semi-controlled environment

microorganisms •

Wound cleansing in a residential facility

Dressing Types, Indicators and Application: • • •

Medicated: such as honey, silver, antiseptic, and

Option for a shower would require same instructions as acute care settings

iodine

•

Assess risk factors

Non-medicated: work via actions, such as

•

Share or individual shower area

microbe binding, sequestering, osmotic or hypertonic which include rinsing, moisture

•

Wound cleansing in the home environment

donating, or absorbing if it is wet •

Passive: drying with gauze or non-adherent

•

Assess risk factors

•

Negative Pressure Wound Therapy (NPWT):

•

Health status

such as dressing, without cannister, disposable,

•

Repeated infections

instillation, and incision

•

Capability of doing the task independently

•

Cellular and tissue-based products: matrix and

or requires assisted care

scaffolding and growth factors Wound cleansing considerations:

•

Cleanliness of the home

•

Potable water

•

Equipment available and condition

•

Same instructions as previous environments

•

If cleaning wound and periwound once

•

Patient’s health related factors

•

Wound characteristics

shower completed options are in the

•

Availability of products/ equipment

shower or using a container

•

Complexity of the wound dressing procedure

•

Environment of where the wound dressing

Showers are encouraged for patients, however if

procedure will occur – such as unpredictable

there are repeated infections it is advised to keep the

home settings, or the controlled clean hospital

wound covered, irrespective of if it gets wet, as this

setting

can be changed after the shower.

•

Local policies and procedures

•

Wound cleansing in an acute hospital inpatient

thought should be evident in practice to ensure

setting:

cleanliness is achieved.

When wound cleansing in a home setting, care and

•

If

having

a

shower

(based

on

risk

Choices of Aseptic Technique

•

Cover the wounds during general hygiene.

Aseptic technique is based on:

•

After general hygiene patient removed

assessment)

•

from shower area if in shared shower

•

Sequencing

arrangement, remove the dressings and

•

Environmental control

cleanse the wound and periwound.

•

Hand hygiene

If single shower and minimal risk factors

•

Maintenance of aseptic fields

after general hygiene remove dressing

•

Equipment requirements

in the shower and cleanse (complete the

•

PPE

dressing application elsewhere) •

Use clean or disposable cloths to pat dry the area

•

Wound cleansing in a clinic or GP •

Option to remove their bandages/ dressings at home and cleanse prior to coming in (check risk factors and home environment)

•

Same principles for cleaning the wound and periwound, cover wound in shower

•

Either bring in the old dressing, take a photo or describe how the old dressing looked

100

Wound Masterclass - Vol 2 - December 2023

MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation Figure 16: Value-based healthcare.

The Standard Aseptic Technique

impact over an inexpensive option will prove itself to be the better option. This is due to the way in which

The concept of standardizing care for wounds in

an inexpensive option can add up, as opposed to the

different environments and patients has many

lower frequent costs of better value options.

challenges and is not seen to be suitable for clinicians wanting to hold a patient centric approach in their

Wound Hygiene and Health Economics

clinics. There are many risk factors, for example if the patient is severely immunocompromised, greater

When the recommended antiseptics and treatment

precautions are necessary. Similarly, in a home

programs are used, then the antibiotic antimicrobial

environment or controlled environment, there are

usage is reduced, as well as the length of treatment

different precautions and factors to consider. This

therefore providing more wound free days. This

also includes access to resources and equipment

results to an overall reduced price of therapy.

such as complex stainless-steel trolleys or dressing

Evidence in trials, product evaluation and case studies

trays. Following a patient centred approach would

all indicate that wound bed preparation provides

enable consistent quality of wound care depending

good health economics.10

on the circumstance, over standardizing and creating a rigid approach that will not be beneficial nor

Wound Bed Preparation for What You Can and Can’t

optimise results.

See.

Value Based Healthcare

Figure 17 is an augmented assessment using a fluorescent device. This helps to improve cleansing. In

When looking at the costs of wound care, it is very

a study showing the benefits of improved cleansing,

important to see the value in the option. Figure 32

there was:

portrays option B being cheaper, but causing to be more cost ineffective as it causes more later issues.

•

33% decrease in antimicrobial prescriptions

The value outweighs the initial cost point of the

•

49% decrease in prescription of antimicrobial

option.

dressings •

The frequency may also shift which option is cost effective. A high value product that can have a better

23% increase in wound healing rates within 12 weeks

•

2% decrease in amputation rate

Wound Masterclass - Vol 2 - December 2023

101

MasterSeries 60 Minute Interactive: All Roads Lead to Healing: Mastering Wound Bed Preparation This evidence shows the drastic benefits of

Figure 18: Immunofluorescence aiding in evaluation of a wound.

improving cleansing and conducting wound bed preparation in one year.

Key Points To conclude, it is important to note that: •

Every wound dressing procedure matters

•

What you do or don’t do may affect the outcome of wound healing in the short term or long term

•

Assessment and diagnosis are key to providing appropriate and targeted therapy

Invest in healing by investing the time to: •

Provide aseptic technique or subscribe to the local wound infection and prevention protocols

•

Thorough

assessment

of

the

wound

and

wound/

periwound •

Therapeutic

periwound

cleansing/ debriding and cleansing •

Appropriate

wound

dressing

based

wound

goals

on

and

selection patient

preferences •

Monitoring

progress

and

making

appropriate referrals

References 1. Six Domains of Health Care Quality. Content last reviewed November 2018.

Agency for Healthcare Research and Quality, Rockville, MD. - https://www.ahrq.gov/ talkingquality/measures/six-domains.htm 2. Naomi Fearns et al., 2017, Placing the patient at the centre of chronic wound care: A qualitative evidence synthesis. Journal of Tissue Viability, 26, 4, 254-259 3. Gethin, G., Vellinga, A., Tawfick, W., O’Loughlin, A., McIntosh, C., Mac Gilchrist, C., Murphy, L., Ejiugwo, M., O’Regan, M., Cameron, A., & Ivory, J. D. (2021). The profile of patients with venous leg ulcers: A systematic review and global perspective. Journal of tissue viability, 30(1), 78–88. https://doi.org/10.1016/j.jtv.2020.08.003 4. Sibbald et al., 2021, Wound Healing Southern Africa, 14 (2), 52-60 5. Dowsett C Et Al Triangle Of Wound Assessment Made Easy Wounds International 2015 6. Wounds International 2019 | Vol 10 Issue 4 | Wounds International 2019 7. Rodeheaver GT, Ratliff CR (2007) Wound Cleansing, Wound Irrigation, Wound Disinfection. In: Rodeheaver GT, Krasner DI, Sibbald RG eds. Chronic Wound Care: A Clinical Source Book for Healthcare Professionals. HMP Communications, Malvern, P.A. 8. White W & Asimus M (2014) Assessment and management of non-viable tissue. In: Wound Management for the Advanced Practitioner Edited by Swanson T, Asimus M and McGuiness B. IP Communications 9. Murphy, C., Atkin, L., Dissemond, J., Hurlow, J., Tan, Y. K., Apelqvist, J., James, G., Salles, N., Wu, J., Tachi, M., & Wolcott, R. (2019). Defying hard-to-heal wounds with an early antibiofilm intervention strategy: ‘wound hygiene’. Journal of wound care, 28(12), 818–822. https://doi.org/10.12968/jowc.2019.28.12.818 10. Queen, D. and Harding, K. (2023), What’s the true costs of wounds faced by different healthcare systems around the world? Int Wound J, 20: 3935-3938. https:// doi.org/10.1111/iwj.14491 11. Dunk, A.M. et al. (2023) A ‘quick guide’ to Pressure Injury Management, Wounds International. Available at: https://woundsinternational.com/supplements/a-quickguide-to-pressure-injury-management/ 12. The wound care pathway - corporate - coloplast. Available at: https://www. coloplast.com/products/wound/the-wound-care-pathway/ (Accessed: 16 December 2023).

13. Swanson, T., Ousey, K., Haesler, E., Bjarnsholt, T., Carville, K., Idensohn, P., Kalan, L., Keast, D. H., Larsen, D., Percival, S., Schultz, G., Sussman, G., Waters, N., & Weir, D. (2022). IWII Wound Infection in Clinical Practice consensus document: 2022 update.

Journal of wound care, 31(Sup12), S10–S21. https://doi.org/10.12968/jowc.2022.31.

Sup12.S10 14. Schaper, N. C., van Netten, J. J., Apelqvist, J., Bus, S. A., Fitridge, R., Game, F., Monteiro-Soares, M., Senneville, E., & IWGDF Editorial Board (2023). Practical guidelines on the prevention and management of diabetes-related foot disease (IWGDF 2023 update). Diabetes/metabolism research and reviews, e3657. Advance online publication. https://doi.org/10.1002/dmrr.3657

102

Wound Masterclass - Vol 2 - December 2023

See all Wound Masterclass MasterSeries on demand: bigmarker.com/wound-masterclass