Cross-Linked ExtraCellular Matrix With PHMB to Manage Lower Extremity Wounds

Cross-Linked ExtraCellular Matrix With PHMB to Manage Lower Extremity Wounds Editorial Summary Patients with chronic and hard-to-heal wounds, such as diabetic foot ulcers and venous leg ulcers, experience significant morbidity such as pain, and loss of function. Initial management includes debriding necrotic tissue, applying dressings that maintain a moist wound environment, treating any concurrent wound infections, and restoring blood flow to the wound site. If these procedures fail to restore the healing process, additional therapies may be considered.

Introduction

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hronic wounds fail to heal due to a variety of systemic and local factors including high microbial burden and excessive devitalized tissue1.

Patients with chronic and hard-to-heal wounds, such as Diabetic Foot Ulcers (DFUs) and Venous Leg Ulcers (VLUs), experience significant morbidity such as pain, and loss of function. Initial management includes debriding necrotic tissue, applying dressings that maintain a moist wound environment, treating any concurrent wound infections, and restoring blood flow to the wound site. If these procedures fail to restore the healing process, additional therapies may be considered.

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Healing becomes compromised once bacteria from the environment invade and biofilm forms2.

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Biofilm is an assemblage of surfaceassociated microbes enclosed in a selfproduced matrix.

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Identifying and managing biofilm is a crucial component of successful wound care protocols2.

and VLUs can all be treated with skin substitutes.

Wound treatment with PHMB antimicrobial barrier (PCMP)* can safely and effectively manage bacterial bioburden3,4.

PuraPly® Antimicrobial Wound Matrix (PuraPly® AM) consists of a collagen sheet coated with 0.1% Polyhex-Methylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly® AM is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.

PuraPly® AM Wound Matrix is a native, crosslinked ECM plus PHMB antimicrobial barrier, intended for the management of acute and chronic wounds including partial- and fullthickness wounds, pressure ulcers, surgical wounds, trauma wounds, and venous and diabetic ulcers.

* PuraPly®AM, Organogenesis Inc., Canton, MA

College of Podiatric Medicine, Kent State University Kent OH, United States

This study aimed to provide foundational data on the effects of a native cross-linked extra cellular matrix with PHMB antimicrobial barrier (PCMP)* on modulating bioburden and reformation of biofilm to support wound healing.

Methods Skin substitutes can be categorised based on the Davison-Kotler classification system.

Briefly they can be categorized as synthetic skin substitutes, acellular dermal substitutes derived from human placental membranes, cellular dermal substitutes, cellular epidermal and dermal substitutes, and animal tissue sources. DFUs, Pressure Ulcers (PUs),

Dr Windy Cole

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5 subjects >18 years old with an open wound of the lower extremity of various etiologies (DFU, VLU, latrogenic) were included.

Dr Janina Krumbeck Director of Microbiome Applications, Zymo Research Corporation Irvine CA, United States

Subjects had weekly clinical visits for the 6-week study period incorporating

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Cross-Linked ExtraCellular Matrix With PHMB to Manage Lower Extremity Wounds

debridement followed by PCMP application.

Summary of Results

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Secondary dressings were applied to maintain a moist wound environment.

The mean baseline wound duration was 23 weeks, and mean baseline size was 7.86 cm2; two of the 5 wounds healed by week 4.

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DFUs on weight bearing areas were offloaded and all VLUs were compressed.

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A fluorescence imaging device** captured fluorescence images to assess high levels of bacterial contamination and standard images with measurements5.

The mean percentage area reduction of all wounds was 59.7% by week 4, and 78.1% by week 6. All wounds displayed positive fluorescence on week 1, progressing to negative fluorescence by week 4.

Subject 3: MolecuLight Bacteria Contamination Images Standard image and measurement upon intake

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F1 image upon intake

Standard image and measurement at second visit

Standard image at study completion visit

F1 image at study completion visit

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F1 image at second visit

Cross-Linked ExtraCellular Matrix With PHMB to Manage Lower Extremity Wounds

Conclusion PCMP was able to resist proteolytic degradation and retain a sustained antimicrobial barrier effect.

The results of this pilot study support the hypothesis that incorporation of PCMP into current clinical pathways supports the wound healing environment, through the resolution of bacterial burden and biofilm reformation, to improve patient outcomes.

A larger study group should be considered that reports clinical outcomes, such as recurrent wounds, amputation, and patient-related outcomes, such as return to function, pain, exudate, and odor.

References 1. Frykberg R, Banks J. Challenges in the Treatment of Chronic Wounds. Advances in Wound Care. 2015: 4(9):560-582.

2. Swanson T, Wolcott R, Wallis H, Woodmansey E. Understanding biofilm in practice: a global survey of health professionals. Journal of Wound Care. 2017;26(8):426440.

3. Gilliver S. PHMB: A well tolerated antiseptic with no reported toxic effects. Journal of Wound Care. 2009; Suppl:9-14.

4. Butcher M. PHMB: an effective antimicrobial in

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