A randomized, controlled trial of negative pressure wound therapy of pressure ulcers via a novel polyurethane foam.

The objectives of the study were (1) to look for any local, clinically apparent response, within and around a debrided wound, to a novel biocompatible polyurethane foam during repeated, short-term implantation, and (2) to assess the material's efficacy as a negative pressure wound therapy (NPWT) interface compared with a widely used, commercially available foam. Twenty pressure ulcers in 18 patients underwent surgical debridement, then randomization to receive novel treatment or control foam as the wound interface for NPWT. Dressing changes every 2-3 days allowed qualitative wound assessment and quantitative measurement to compare outcomes. No adverse reaction was observed in any patient receiving the new foam. The new "novel foam" performed as a NPWT interface as effectively as the control "standard foam." In deep wounds, the new foam was easier to remove, fragmented less, and showed less retention than the control foam. No marginal in-growth occurred, making removal less traumatic and reducing bleeding from cavity wall granulations. The results support previous large animal studies, and independent ISO10993 testing, that the new foam is safe and biocompatible. Its efficacy as an NPWT interface, nontraumatic removal with low fragmentation and retention rate, favors the new material, especially in deep cavity wounds.

RCT Entities:   Population Interventions Outcomes