Use of a Purified Collagen Matrix Plus Polyhexamethylene Biguanide Antimicrobial in the Management of Non-Healing Pressure Ulcers

Background: Many variables, including the products used for managing and treating varying wound types can affect the rate and extent of healing.

Objective: This prospective, observational 12-week study explored the effects of a purified native collagen matrix plus polyhexamethylene biguanide (PCMP) in the management of non-healing pressure ulcers (PUs), regardless of anatomical location.

Methods: Key exclusion criteria included patients with sensitivity to porcine materials or polyhexamethylene biguanide, patients with third degree burns, and/or those receiving concurrent treatment with other topical antimicrobials or skin substitute products. Ulcers were evaluated weekly for size, complete closure, and signs of infection. Debridement was performed as necessary to remove any necrotic and hyperkeratotic tissue. Eighteen patients with PUs were enrolled. At baseline wound sizes ranged between 0.3 cm² - 218.5 cm².

Results: Seven out of 18 patients with PUs achieved complete wound closure (CWC). Of the 11 remaining PUs, wound surface area decreased by >40% in three and by >80% in two ulcers by Week 4. By Week 12, there was a mean decrease in wound size of 4.9 cm2. Overall, 13 PUs reduced in size during the 12-week follow-up period. Of these, 5 did not achieve CWC: two Stage IV ulcers with a 4-year duration were bridged to alternate therapies (e.g., plastic surgery), and three (2 Stage IV, 1 Stage III) with >1-year duration slightly increased in size. No patients showed any signs of complications or infections throughout the course of the study.

Conclusion: Overall, this prospective, observational study with PCMP resulted in meaningful clinical outcomes (e.g., surface area reduction, increased granulation tissue, CWC, etc.) which may indicate that this product positively impacts the wound healing process. These results need to be further evaluated and validated with randomized, controlled trials in a larger sample of patients.