Effectiveness of a native Type I Collagen matrix plus polyhexamethylene biguanide (PHMB) antimicrobial in the treatment of venous leg ulcers in a real-world setting

Objective: To analyze the subgroup of Venous Leg Ulcers (VLUs) in the 28 site, prospective, non-interventional, PCMP registry (RESPOND)(a) that evaluated the real-world effectiveness of PCMP(b) (native Type I Collagen matrix plus PHMB; polyhexamethylene biguanide antimicrobial) on chronic and acute wounds.

Methods: PCMP is intended for the management of partial and full thickness wounds (except 3rd degree burns) and as an effective barrier to reduce microbes penetrating through the dressing. All patients (n=307) in RESPOND received PCMP. Male and female patients, ≥18 years with cutaneous wounds not including third degree burns were eligible for participation. Wounds ≥0.2 and < 200 cm were included. PCMP was used for up to 24 weekly visits, and patients were followed for 32 weeks. The analyses included 67 (22%) VLUs; 62 (20%) Diabetic Foot Ulcers (DFUs); 45 (15%) Pressure Ulcers (PRUs); 54 (18%) Post-Surgical Wounds (PSWs); and 79 (26%) Other wounds. All wounds (n=307) and subgroups were analyzed to determine the frequency and median time to wound closure using Kaplan-Meier (K-M) methods.

Results: For the cohort of PCPM-treated VLUs (n=67), mean baseline area, duration, depth, and volume were 8.6 cm2, 2.2 months, 0.2 cm, and 6.3 cm3, respectively. Frequencies of wound closure were 53, 64 and 73% at week 20, 26, and 32, respectively. The median time to wound closure was 22 weeks. Analyses of wound closure for All, DFUs, PRUs, PSWs, and Other wounds showed frequencies of 73, 51, 62, 96, and 67%, respectively. Median times to wound closure were 17, 31, 32, 12, and 14 weeks.

Conclusions: VLUs in the PCMP registry showed a frequency and median time to wound closure of 73% and 22 weeks, respectively. All wounds showed 73% and 17 weeks. PCMP appears to be a useful adjunct in the treatment of VLUs and other wound types.
 (a) RESPOND Registry; Real-World Effectiveness Study of PuraPly AM®AM on Wounds
(b) PuraPly AM®, Organogenesis Inc, Canton, MA

Trademarked Items (if applicable): (a) RESPOND Registry; Real-World Effectiveness Study of PuraPly AM®AM on Wounds
(b) PuraPly AM®, Organogenesis Inc, Canton, MA

References (if applicable):