The effect of recombinant growth hormone on wound-healing in severly burned adults. A placebo-controlled, randomized double-blind phase II study

Introduction: Recombinant growth hormone (rGH) has been used successfully i n burned children with a shortened donor-site healing time and length of ho spital stay as well as a protein-sparing effect. In adult burn patients, no comparable study exists to date. Material and methods: The study was perfo rmed on 49 adults, aged 18-60, with an Abbreviated Burn Severity Index (ABS I) score of 7-I1 as a randomized, placebo-controlled, double-blind study. T he treatment period was 28 days and follow-up period 1 year. rGH was admini stered subcutaneously at a dose of 0.5 IU/kg per day in 26 patients, 23 pat ients were in the placebo group. Wound-closure assessment was performed on the day of admission and on each day of dressing change. A wound-closure in dex (WCI) was calculated. Results: Thirty-seven patients, 19 in the rGH gro up and 18 in the placebo group, survived and were available for primary eff icacy analysis. The mean total body surface area (TBSA) burned was 41.5% (r GH) versus 36.7% (placebo); the average ABSI score was 8.27 (rGH) versus 7. 9 (placebo). The wound-closure index was not significantly different in pat ients treated with rGH (1.92) compared with patients treated with placebo ( 1.72). WCI for partial thickness-loss burn wounds did not significantly dif fer from rGH (0.9) to placebo (0169). The donor site healing time in rGH-tr eated patients (12 days) was not significantly different compared to placeb o patients (10.4 days). Conclusion: In severely burned adult patients rGH h as no positive effect on burn wound or donor-site healing.