Pilot Study Investigating the Effects of a Native Cross-Linked Extra Cellular Matrix with PHMB to Manage Chronic Lower Extremity Wounds Exhibiting Bacterial Contamination as Determined by a Novel Violet-Light Imaging System

Introduction: Chronic wounds fail to heal due to a variety of systemic and local factors including high microbial burden and excessive devitalized tissue. Healing becomes compromised once bacteria from the environment invade and biofilm forms. Biofilm is an assemblage of surface-associated microbes enclosed in a self-produced matrix. Identifying and managing biofilm is a crucial component of successful wound care protocols.

Objective: 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: 5 subjects >18 years old with open wound of the lower extremity of various etiologies including 3 venous leg ulcers, 1 diabetic foot ulcer, and 1 iatrogenic ulcer. An ICF was signed prior to participation in the study. Subjects had weekly clinical visits for the 6-week study period. A fluorescence imaging device captured fluorescence images to assess high levels of bacterial contamination and standard images with measurements. Debridement was performed as SOC using surgical blade or curette. Tissue swabs were obtained per protocol and analyzed using next-generation sequencing to identity and quantify common bacterial sequences. PCMP was applied to the wound at each treatment visit per manufacturer’s guidelines. Secondary dressings were applied to maintain a moist wound environment. DFUs on weightbearing areas were offloaded and all VLUs were compressed.

Results: Mean baseline wound duration was 23 weeks, and mean baseline size was 7.86cm2 . Two of the 5 wounds healed by week 4. The mean percentage area reduction of all wounds was 59.70% by week 4 and 78.10% by week 6. All wounds displayed positive fluorescence on week 1 progressing to negative fluorescence by week 4.

Conclusion: PCMP was able to resist proteolytic degradation and retain a continuous 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.