Multicenter trial to evaluate the safety and potential efficacy of pooled human fibrin sealant for the treatment of burn wounds

Objective: The primary purpose of this multicenter study was to evaluate th e safety and potential efficacy of a solvent/detergent-treated commercial f ibrin sealant (human) for topical hemostasis in skin grafting. Methods: The study involved a prospective evaluation of changes in viral ti ters in patients with burns less than 15% after treatment,vith fibrin seala nt (human), Each patient served as his/her own control for an unblinded, ra ndomized comparison of donor site hemostasis and healing. Preoperative seru m was obtained to screen for viral titers, At autografting, the recipient s ite and one of two randomly chosen donor sites were treated,vith fibrin sea lant (human), The use of other hemostatic agents, including epinephrine was prohibited. Each donor site was covered with gauze to collect blood for es timation of the relative amount of bleeding. The healing of the graft and d onor sites was observed. Viral titers and wounds were checked monthly for 6 months, and at 9 and 12 months postoperatively, Results: Viral titers for human immunodeficiency virus; hepatitis A, B, and C; Epstein-Barr virus; and cytomegalovirus were obtained before and after treatment. Of 47 patients, 34 completed the full year of observation. After treatment, there were no seroconversions to any of the aforementioned viru ses. Bleeding at the recipient site appeared well controlled with fibrin se alant (human), Although investigators felt that fibrin sealant (human) impr oved donor site hemostasis, differences in hemoglobin measurements of blood -soaked dressings failed to reach significance. No differences were noted w ith regard to acceleration of donor site healing, graft take, or scar matur ation at the two groups of donor sites. Anecdotally, the maturation of the recipient site appeared to be accelerated. Conclusion: Fibrin sealant (hunan) is safe for use during excision and graf ting, and its topical hemostatic potential needs to be examined in patients with larger burns. Its role in scar maturation also needs to be investigat ed.