[Effect of recombinant growth hormone on wound healing in severely burned adults. A placebo controlled, randomized double-blind phase II study].
BACKGROUND
Recombinant growth hormone (rGH) has been used successfully in burned children with a shortened donor-site healing time and length of hospital stay as well as a protein-sparing effect. In adult burn patients, no comparable study exists to date.


METHODS
The study was performed on 49 adults, aged 18-60, with an Abbreviated Burn Severity Index (ABSI) score of 7-I1 as a randomized, placebo-controlled, double-blind study. The treatment period was 28 days and follow-up period 1 year. rGH was administered subcutaneously at a dose of 0.5 lU/kg per day in 26 patients, 23 patients 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 index (WCI) was calculated.


RESULTS
Thirty-seven patients, 19 in the rGH group and 18 in the placebo group, survived and were available for primary efficacy analysis. The mean total body surface area (TBSA) burned was 41.5% (rGH) 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 patients treated with rGH (1.92) compared with patients treated with placebo (1.72). WCI for partial thickness-loss burn wounds did not significantly differ from rGH (0.9) to placebo (0.69). The donor site healing time in rGH-treated patients (12 days) was not significantly different compared to placebo patients (10.4 days).


CONCLUSIONS
In severely burned adult patients rGH has no positive effect on burn wound or donor-site healing.
Pelzer
M
M
Abteilung Verbrennung, Plastische und Handchirurgie, BG-Unfallklinik Ludwigshafen, Plastische und Handchirurgie der Ruprecht Karls Universität Heidelberg, Ludwigshafen. michael.pelzer@urz.uni-heidelberg.de
Hartmann
B
B
Blome-Eberwein
S
S
Raff
T
T
Germann
G
G
D000293:Adolescent; D000328:Adult; D002056:Burns / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D019382:Human Growth Hormone / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D016038:Skin Transplantation; D014945:Wound Healing / Q000187:drug effects
D019382:Human Growth Hormone