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.