A prospective observational study on the use of a native collagen plus polyhexamethylene biguanide on non-healing wounds

Objective: To observe the effect of a topical, purified, native type 1 collagen bilayer extracellular matrix with polyhexamethylene biguanide (PHMB) antimicrobial (PCMP; PuraPly RAM; Organogenesis Inc., Canton, MA) in treating chronic wounds.

Approach: Single-site, prospective, observational study on the feasibility of using PCMP for the treatment of chronic wounds in an office and operating room setting. 

Prospectively-obtained data on the use and outcomes of PCMP on wounds were recorded using standardized electronic data collection. All wounds were eligible for inclusion except third-degree burns. PCMP was applied weekly for up to 12 weeks in addition to standard of care. Topical dressings included alginates, petrolatum gauze, negative pressure, foams and plain gauze. Topical antimicrobial dressings were not permitted with PCMP application; however, if infection was suspected topical and systemic antibiotics were prescribed and PCMP was held until active infection resolved.

Results: One hundred ten subjects were screened, 86 (41 males [47.7%], 45 females [52.3%]) completed 4 or more weeks of PCMP applications and were included in the final analysis. The study included 11 wound types, with a mean (±standard deviation) initial wound size of 34.1 (± 93.7) cm2. A total of 39 (45.0%) wounds closed - 29 healed with PCMP alone, 10 were bridged to adjunctive treatment.  PCMP was applied in the operating room, 19 patients and office 67 patients. There were no serious adverse events.

Conclusion: PCMP is useful as a topical treatment for chronic wounds and can be easily applied in the office or the operating room.