An exploratory study of dermal replacement therapy in the treatment of stage III pressure ulcers

Objective: To compare the proportion of patients with Stage III pressure ulcers with complete wound closure at Week 24, when treated with conventional therapy or conventional therapy plus a human fibroblast-derived dermal replacement. Methods: A prospective, multi-center, randomized, single-masked, controlled exploratory study was conducted comparing Dermagraft with conventional therapy alone. The primary measure was wound closure at 24 weeks. Secondary measures were wound closure at Week 12 and the percentage reduction in wound area and volume. Results: There were no significant differences found between the treatment groups with respect to the proportions of patients healing by Week 24. Two (11%) Dermagraft and 2 control (13%) patients had healed by Week 24. There were no significant differences found between the treatment groups with respect to the percentage reduction in ulcer area or the percentage reduction in ulcer volume by Week 12 (last observations carried forward). The reduction in wound volume was 41.2% for the Dermagraft arm and 17.4% for the control arm at study end. Conclusions: The primary study endpoint (proportion of patients with complete wound closure) was observed in a small number of patients. The positive trend in reduction of wound volume achieved in the treatment arm of the study may be significant in facilitating other treatment modalities, such as surgical closure. Further clinical studies are needed to establish the place of dermal replacement therapy in the management of chronic pressure ulcers.