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

OBJECTIVES: To analyze pooled data from three distinct prospective, non-interventional, cohort studies that examined the effectiveness of purified native Type I collagen matrix plus PHMB antimicrobial (PCMP(a)) on cutaneous wounds.

METHODS: 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. Patient data were pooled from three studies: 1) n=41(b), 2) n=86(c), and 3) n=307(d). All patients (n=434) 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.

RESULTS: The analyses included 95 (22%) Venous Leg Ulcers (VLUs); 78 (18%) Diabetic Foot Ulcers (DFUs); 90 (21%) Pressure Ulcers (PRUs); 73 (17%) Post-Surgical Wounds (PSWs); and 98 (23%) wounds of Other etiologies. Mean baseline area, depth, and volume (n=434) were 15.1 cm2, 0.5 cm, and 7.9 cm3, respectively. Kaplan-Meier analysis showed that for All wounds (n=434), the median time to wound closure was 19 weeks. The frequency of wound closure for all wound types was 50, 56, and 72% at week 18, 24, and 36, respectively. For PRUs, VLUs, DFUs, PSWs, and Other etiologies the median times to wound closure were 23, 22, 24, 12, and 14 weeks. The proportions of wounds closed were 63% (PRUs), 72% (VLUs), 52% (DFUs), 95% (PSWs), and 67% (Other etiologies).

CONCLUSIONS: This PCMP cohort analysis of 434 patients treated at 30 wound care facilities showed a 72% frequency of wound closure with a median time of 19 weeks. Consistent results were demonstrated across all participating sites and wound types. PCMP appears to be a useful adjunct in the treatment of various types of wounds.

(a) PCMP (PuraPly AM®; Organogenesis Inc., Canton MA 02038)
(b) Northwell Health, Lake Success, NY; single center, 41 patients
(c) Langone Hospital, Mineola, NY; single center, 86 patients
(d) The PCMP study group; RESPOND registry (Real-World Effectiveness Study of PuraPly AM® on Wounds); 28 centers, 307 patients

Trademarked Items (if applicable): (a) PCMP (PuraPly AM®; Organogenesis Inc., Canton MA 02038)

References (if applicable):