Long-term safety and efficacy with Fibrel in the treatment of cutaneous scars--results of a multicenter study. Multicenter study group.

Three hundred patients were treated with Fibrel (Serono Laboratories, Randolph, MA) for the correction of cutaneous scars. Fibrel treatment was restricted to four scars with one or two treatments following a negative skin test. The scar corrections were evaluated by the physician, the patient, and also via an objective photogrammetric method. At the end of 1 year, the percentages of scars with moderate, marked, or complete correction were 65.0%, 63.3%, and 85.8% according to physician, patient, and photogrammetric evaluations, respectively. A cohort of 111 patients from the 1-year study were followed for up to 2 years postimplantation to evaluate safety and efficacy. These patients had similar demographic and scar characteristics as the total patient population in the initial study. The efficacy evaluation at the end of 24 months indicated that successful correction was maintained in 64.4%, 58.9%, and 78.9% of scars for physician, patient, and photogrammetric evaluations, respectively. There were no severe hypersensitivity reactions following treatment with Fibrel. The data from these patients demonstrate that one or two Fibrel treatments are effective in maintaining the correction of depressed cutaneous scars for up to 2 years with negligible adverse sequelae.