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Randomized Controlled Trial Multicenter Study
Effects of oxandrolone on outcome measures in the severely burned: a multicenter prospective randomized double-blind trial.
- Steven E Wolf, Linda S Edelman, Nathan Kemalyan, Lorraine Donison, James Cross, Marcia Underwood, Robert J Spence, Dene Noppenberger, Tina L Palmieri, David G Greenhalgh, Marybeth Lawless, David Voigt, Paul Edwards, Petra Warner, Richard Kagan, Susan Hatfield, James Jeng, Daria Crean, John Hunt, Gary Purdue, Agnes Burris, Bruce Cairns, Mary Kessler, Robert L Klein, Rose Baker, Charles Yowler, Wendy Tutulo, Kevin Foster, Daniel Caruso, Brian Hildebrand, Wesley Benjamin, Cynthia Villarreal, Arthur P Sanford, and Jeffrey Saffle.
- BART (Burn Applied Research Team): the Blocker Burn Unit University of Texas Medical Branch, USA.
- J Burn Care Res. 2006 Mar 1;27(2):131-9; discussion 140-1.
AbstractSevere burns induce pathophysiologic problems, among them catabolism of lean mass, leading to protracted hospitalization and prolonged recovery. Oxandrolone is an anabolic agent shown to decrease lean mass catabolism and improve wound healing in the severely burned patients. We enrolled 81 adult subjects with burns 20% to 60% TBSA in a multicenter trial testing the effects of oxandrolone on length of hospital stay. Subjects were randomized between oxandrolone 10 mg every 12 hours or placebo. The study was stopped halfway through projected enrollment because of a significant difference between groups found on planned interim analysis. We found that length of stay was shorter in the oxandrolone group (31.6 +/- 3.1 days) than placebo (43.3 +/- 5.3 days; P < .05). This difference strengthened when deaths were excluded and hospital stay was indexed to burn size (1.24 +/- 0.15 days/% TBSA burned vs 0.87 +/- 0.05 days/% TBSA burned, P < .05). We conclude that treatment using oxandrolone should be considered for use in the severely burned while hepatic transaminases are monitored.
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