Combination of ECM Replacement and NPWT Speeds up the Healing in Challenging Stage Iv Pressure Ulcer

September - October 2022

Combination Therapies: Does ECM Replacement and NPWT Speed Up the Healing in Challenging Stage IV Pressure Ulcers?

Editorial Summary Challenging non-healing wounds can prove a challenge to the wound care provider. As this article explores, consideration of combination therapies, which sequence different wound treatment modalities, can help flick the switch in the healing process.

Introduction

C

hronic non-healing wounds lead to enormous financial burden on the health care system, resulting in costs of more than $25 billion annually in the United States alone.1 These wounds are stuck in the inflammatory phase with increased levels of harmful metalloproteases.

Preoperative Factors All patients may not qualify or may decline flap reconstruction. Stage IV pressure ulcers are best covered with fascio or myocutaneous flaps.

Addressing the etiology and associated risks of these wounds prior to surgery is key, since their complication and recurrence rates are very high.2 Other factors will of course influence the outcome such as compliance, nutrition status, offloading, ruling out osteomyelitis, clean wounds with no soft tissue infection, being on certain medications, and others. In patients who may not be a good candidate for flap closure but have met all the above-mentioned conditions, other therapeutic modalities and their combinations may lead to faster healing.

Cell and Tissue Products Dr Richard Simman Professor of Surgery, Division of Plastic and Reconstructive Surgery, University of Toledo College of Medicine and Life Sciences.

Program Director of Wound Care at Jobst Vascular Institute, ProMedica Health Network Toledo OH, USA

120

Cell and Tissue-Based Products (CTPs) have increased in popularity in the last two decades with their proven favorable effects on chronic hard to heal wounds. They include extra cellular matrix (ECM) replacement (including bioengineered matrices, Allo and Xeno Grafts), cell signaling products and dehydrated, cryopreserved or fresh amniotic and umbilical cord products.3

Wound Masterclass - Vol 1 - September 2022

Extracellular matrix (ECM) derived from small intestinal submucosa (SIS) is widely used in clinical applications as a scaffold for tissue repair.

The SIS-ECM is made from porcine small intestinal submucosa. This product has been previously reported to produce a dressing that inactivates the tissue metalloproteases, thereby preventing destruction of the provisional ECM. Its composition stimulates cell migration, reduces inflammation, and provides moisture to the wound bed; SIS-ECM also grants structural support and enhances cellular proliferation and attachments. The SIS-ECM has been employed for a variety of wounds including: • • • • • •

Chronic vascular Venous ulcers Diabetic ulcers Partial-thickness burns Donor sites and skin graft preparation Partial and full-thickness, surgical, and traumatic wounds4

In a recently published manuscript, we demonstrated with a prospective randomized controlled trial that combining ECM replacement with negative pressure wound therapy (NPWT) will hasten the healing rate in this patient population.5 In this study 16 patients were randomized to receive either the SIS-ECM plus NPWT (8 study) or NPWT alone (8 control) for stage 4 pressure ulcers treatment. Wounds were photographed and measured weekly. The experimental group had their ECM dressings changed every other week and their NPWT changed twice weekly. After the 12-week study period, the average control

Combination Therapies: Does ECM Replacement and NPWT Speed Up the Healing in Challenging Stage IV Pressure Ulcers?

“The SIS-ECM is made from porcine small intestinal submucosa. This product has been previously reported to produce a dressing that inactivates the tissue metalloproteases, thereby preventing destruction of the provisional ECM.” 4

patient healing rate was 45.79% as compared with the 89.98% healing rate in the study group (P < .01). The difference in healing rate between control and study patients was optimal by 12 weeks.5

Discussion

References 1. Frade MAC, Das PK. Chronic ulcers: updating epidemiology, physiopathology, and therapies. Ulcers. 2013. doi:10.1155/2013/964826.

2. Ravinder B. et al. Flap Reconstruction for Pressure Ulcers: An Outcomes Analysis.

PlastReconstr Surg Glob Open. 2017 Jan 18;5(1):e1187. doi: 10.1097/GOX.0000000000001187.

3. Rubin JP et al. Regulatory Advocacy Update: ASPS Comments in Response to the U.S Food and Drug Administration Draft Guidance Documents on Human Cell and Tissue Products. Plast and Reconstruct Surg: May 2017, vol 139-issue 5-page 1259-1261.

4. Abouissa A, Mari W, Simman R. Clinical usage of an extracellular, collagen-rich matrix: a case series. Wounds. 2015;27(11):313–318.

5. Mari W, Simman R, et al. Use of a Natural Porcine Extracellular Matrix with Negative Pressure Wound Therapy Hastens the Healing Rate in Stage 4 Pressure Ulcers. Wounds 2019;31(5):117–122. Epub 2019 March 15.

The study was limited by the small number of participating patients, although it demonstrates that wound care providers, when faced with challenging non healing wounds, should consider combined therapies to improve the healing rate.

Figure 1: 1a: Large stage IV sacral and bilateral gluteal pressure ulcer.

1b: SIS ECM being applied to wound bed before the application of NPWT. 1c: Ulcer surface reduction at 3 months, at the end of the study.

1a

1b

1c

Wound Masterclass - Vol 1 - September 2022

121