Aim: Determine the effectiveness of purified native type I collagen matrix plus polyhexamethylene biguanide antimicrobial (PCMP) on cutaneous wounds. Materials & methods: A prospective cohort study of 307 patients (67 venous leg ulcers, 62 diabetic foot ulcers, 45 pressure ulcers, 54 post-surgical wounds and 79 other wounds) was conducted. Results: Cox wound closure for PCMP was 73% at week 32. The median time to wound closure was 17 weeks (Kaplan-Meier). The incidence of PCMP-treated wounds showing >60% reductions in areas, depths and volumes were 81, 71 and 85%, respectively. Conclusion: PCMP demonstrated clinically meaningful benefits to patients with various types of cutaneous wounds. Clinical Trial registration number: NCT03286452.
Keywords: PCMP; RESPOND registry; chronic wounds; cohort studies; health economics; medical devices; outcomes research; real-world evidence; skin wounds.