PMU6 EFFECTIVENESS OF A NATIVE TYPE I COLLAGEN MATRIX PLUS POLYHEXAMETHYLENE BIGUANIDE ANTIMICROBIAL (PHMB) FOR THE TREATMENT OF CUTANEOUS WOUNDS IN A REAL WORLD SETTING

Abstract

This was a 28 site registry (RESPOND) examining the “real-world” effectiveness of purified native Type I collagen matrix plus PHMB antimicrobial (PCMP) on chronic and acute wounds. PCMP is intended for the management of partial and full thickness wounds (with the exception of third degree burns) and as an effective barrier to reduce microbes penetrating through the dressings. All patients (n=307) in RESPOND received PCMP for up to 24 weeks or until wound closure and were followed for up to 36 weeks. Male and female patients ≥18 years with wounds ≥0.2 and <200 cm2 were included. Third degree burns were excluded. The analyses included 68 (22%) Venous Leg Ulcers (VLUs); 61 (20%) Diabetic Foot Ulcers (DFUs); 46 (15%) Pressure Ulcers (PRUs); 55 (18%) Post-Surgical Wounds (PSWs); and 77 (25%) wounds of Other etiologies. Mean baseline area, duration, depth, and volume (n=307) were 12.9 cm2, 3.2 months, 0.5 cm, and 5.7 cm3 respectively. Kaplan-Meier time to event analyses showed that for All wounds (n=307), the median time to and frequency of wound closure were 17 weeks and 72% wound closure respectively. For PRUs, VLUs, DFUs, PSWs, and Other etiologies the median times to wound closure were 32, 22, 31, 12, and 14 weeks respectively. The proportions of wounds closed were 62% (PRUs), 73% (VLUs), 49% (DFUs), 100% (PSWs), and 67% (Other etiologies). Achieving treatment goals was designated as a co-primary endpoint and was prospectively defined as improvement in wound bed condition such as increase in healthy granulation tissue, reduced exudate, and readiness for grafting or treatment with other advanced skin substitutes. 86% of all PCMP-treated patients met clinicians’ treatment goals. The use of PCMP demonstrated clinically meaningful benefits to patients and comparable wound closure rates for various types of non-healing wounds.