Efficacy of a Bioresorbable Matrix in Healing Complex Chronic Wounds: An Open-Label Prospective Pilot Study

Objective. The goal of this prospective clinical study was to assess the effectiveness of a novel bioresorbable polymeric matrix impregnated with ionic and metallic silver as a primary wound contact dressing in healing stagnant or deteriorating chronic wounds. Materials and Methods. Thirty-two patients with a total of 35 chronic wounds undergoing treatment at the Wound Healing and Hyperbaric Center at Mission Hospital were recruited under a protocol approved by the institutional review board. The wounds included venous stasis ulcers, diabetic foot ulcers, postoperative surgical wounds, burn wounds, and chronic, nonpressure lower extremity ulcers. At baseline, all wounds were nonhealing (ie, stagnant or deteriorating) for a median of 39 weeks (range, 3-137 weeks) and suspected of persistent microbial colonization that had not responded to traditional antimicrobial products and/or antibiotics. The aforementioned matrix was applied to wounds once every 3 days and covered with a secondary dressing. Previously prescribed protocols of care, such as debridement or compression wraps, were continued, but prior antimicrobial dressings or antibiotics were replaced with the matrix. Wound assessments at 3 weeks and 12 weeks post intervention are reported. Results. Three patients were excluded due to patients lost to follow-up after initial application. At 3 weeks, 72% of wounds (22/32) had significantly improved healing with an average wound area reduction of 66%. By 12 weeks, 91% of wounds (29/32) either healed completely (ie, fully reepithelialized) or improved significantly with an average wound area reduction of 73%. The matrix was well tolerated; no patient reported discomfort with the application of the matrix. Conclusions. The micrometer-thick bioresorbable matrix presents a new form factor to wound management, conforming intimately to the underlying wound bed to exert localized and sustained antimicrobial action of noncytotoxic levels of silver. The application of the matrix on the wound surface in protocols of care was safe and well tolerated, and it facilitated improvements in healing of a majority of the stagnant or deteriorating complex chronic wounds.