Acceleration of wound healing in traumatic ulcers by absorbable collagen sponge containing recombinant basic fibroblast growth factor.

The objective of this study was to examine the safety and efficacy of topical application of recombinant basic fibroblast growth factor loaded on a kind of absorbable collagen sponge (rbFGF/ACS) in patients with chronic traumatic ulcers. This double-blind controlled trial included 58 patients with chronic traumatic ulcers. The patients were randomized into two groups. After debridement, the wounds were covered with rbFGF/ACS and then bound up with sterile gauze in the rbFGF/ACS group (n = 30), or bound up with petrolatum sterile gauze in the placebo group (n = 28). The complete closure of the wounds was assessed by photography. The wounds that failed to heal were defined as incomplete healing after 3 weeks. Compared with the placebo group, rbFGF/ACS significantly increased the incidence of complete wound closure by 68% (90.0% versus 53.6%, P = 0.0019) after 3 weeks and shortened the time to achieve complete wound closure by 24% (10.6 days versus 13.9 days, P = 0.0171). There was no difference in side effects between the two groups. rbFGF/ACS significantly increased the incidence of complete wound closure, shortened the complete healing time and improved the healing quality of chronic traumatic ulcers. The safety profile in the rbFGF/ACS group was similar to that in placebo group.

RCT Entities:   Population Interventions Outcomes