Use of a Purified Native Collagen Matrix Plus Polyhexamethylene Biguanide (PHMB) Antimicrobial in the Management of Chronic Wounds

Bacterial biofilm has been widely acknowledged as being associated with prolonging the inflammatory phase of wound healing, resulting in increased proteolytic enzymes and degradation of the extracellular matrix. PHMB is known to inhibit the reformation of biofilm on the wound surface. The purpose of this study was to evaluate the effects of a purified native collagen matrix plus polyhexamethylene biguanide antimicrobial (PCMP*) when used concomitantly with usual care in the management of recalcitrant wounds of varying etiologies. This 12-week prospective, observational study enrolled patients with a variety of wounds and ulcers. Wounds were treated with PCMP together with SOC and evaluated weekly for size, closure, granulation and signs of infection. Debridement was performed to remove of biofilm, necrotic, and hyperkeratotic tissue. Of the 104 patients enrolled, 77 (74%) were analyzed. Eleven different wound types with an average baseline surface area of 31.8 cm2 were evaluated during the study. By Week 12, forty (52%) wounds closed including 5 out of 9 diabetic foot ulcers, 11 of 27 pressure ulcers (stages II to IV), and 11 of 20 venous ulcers. Overall, wound size decreased by 35% across all wound types. Of the 37 (48%) wounds that did not heal, there was a mean increase in wound size of 0.98% and improved granulation tissue. In conclusion, the use of PCMP along with good wound care supported both wound closure and improvements in wound bed condition as an effective adjunct to SOC in the management of various types of refractory wounds. These results need to be further evaluated and validated with randomized, controlled trials in a larger sample of patients.