Randomized controlled trial of the application of topical b-FGF-impregnated gelatin microspheres to improve tissue survival in subzone II fingertip amputations.

We undertook a randomized controlled trial of subzone II fingertip amputations, comparing standard treatment with topical application of gelatin microspheres prepared with basic fibroblast growth factor (b-FGF) to provide a slow, sustained release of b-FGF with microsphere degradation. Forty-eight digits from 42 patients were randomized into the two study arms. The microspheres were applied as a paste on exposed tissue surfaces, whereas standard treatment was without any topical treatment. Patients were treated either with microsurgical revascularization or by simple composite graft, based on the surgeon's clinical decision. Tissue survival of the replanted fingertips was measured by a blinded evaluator 3 weeks postoperatively. A modest improvement in survival was seen with b-FGF-microsphere application for both revascularized and composite grafted fingertips, though this did not achieve statistical significance. Whether the slow release of b-FGF through a bioresorbable carrier gives any improvement in outcome in patients with subzone II fingertip amputations is unproven.

RCT Entities:   Population Interventions Outcomes