Effectiveness of a purified type I collagen matrix plus the antimicrobial polyhexamethylene biguanide for use in cutaneous wounds: analysis of a population of three combined registries.

Abstract

Introduction: Chronic wounds represent a significant burden to the health care system and patients.

Objective: This study determined the effectiveness of a wound scaffold comprised of PCMP for use in nonhealing, cutaneous wounds; this study analyzes pooled data from the population of 3 combined registries.

Materials and methods: A total of 3 combined registry populations were pooled from a single-center study of 41 patients, a single-center study of 86 patients, and the RESPOND Registry of 307 patients treated at 28 centers. All 434 patients received PCMP and were followed for up to 48 weeks. Male and female patients 18 years or older with wounds between 0.2 cm2 and 200 cm2 were included.

Results: In total, there were 95 VLUs, 78 DFUs, 90 PIs, 73 PSWs, and 98 wounds of other etiologies analyzed. The mean baseline area, depth, and volume of all 434 wounds was 15.1 cm2, 4.9 mm, and 7.2 cm3, respectively. K-M median time to wound closure for all wounds was 19 weeks. At weeks 20, 24, 28, and 48, the frequency of wound closure for all wounds was 51%, 56%, 62%, and 72%, respectively. The median time to closure by wound type was 22 weeks for VLUs, 24 weeks for DFUs, 23 weeks for PIs, 12 weeks for PSWs, and 14 weeks for other wounds. The proportion of wounds closed were 72% (VLUs), 52% (DFUs), 63% (PIs), 95% (PSWs), and 67% (other etiologies).

Conclusions: This 434-patient PCMP cohort analysis showed 72% wound closure and median time to wound closure of 19 weeks. PCMP demonstrated effectiveness for use in multiple wound types.