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Effects of Oxandrolone on Outcome Measures in the Severely Burned: A Multicenter Prospective Randomized Double-Blind Trial

Wolf, Steven E. MD; Edelman, Linda S.; Kemalyan, Nathan MD; Donison, Lorraine; Cross, James MD; Underwood, Marcia; Spence, Robert J. MD; Noppenberger, Dene; Palmieri, Tina L. MD; Greenhalgh, David G. MD; Lawless, Marybeth; Voigt, David MD; Edwards, Paul; Warner, Petra MD; Kagan, Richard MD; Hatfield, Susan; Jeng, James MD; Crean, Daria; Hunt, John MD; Purdue, Gary MD; Burris, Agnes; Cairns, Bruce MD; Kessler, Mary; Klein, Robert L. MD; Baker, Rose; Yowler, Charles MD; Tutulo, Wendy; Foster, Kevin MD; Caruso, Daniel MD; Hildebrand, Brian; Benjamin, Wesley; Villarreal, Cynthia PharmD; Sanford, Arthur P. MD; Saffle, Jeffrey MD

doi: 10.1097/01.BCR.0000202620.55751.4F
Original Articles

Severe 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.

From BART (Burn Applied Research Team): the Blocker Burn Unit University of Texas Medical Branch; Intermountain Burn and Trauma Center, University of Utah Health Science Center; Baltimore Regional Burn Center, Johns Hopkins Bayview Medical Center, Baltimore, Maryland; MetroHealth Medical Center, Cleveland, Ohio; Parkland Hospital Burn Center, Southwestern Medical Center; Burn Center, Washington Hospital Center; Department of Surgery, University of Cincinnati, Cincinnati, Ohio; Davis Regional Burn Center, University of California, Davis; Arizona Burn Center; University of Alabama Hospital at Birmingham; Oregon Burn Center; St. Elizabeth's Hospital, Lincoln, Nebraska; North Carolina Jaycee Burn Center, University of North Carolina; Regional Burn Trauma Center, Akron, Ohio.

Presented at the meeting of the American Burn Association, Vancouver BC, Canada, Vancouver, British Columbia, Canada, March 24 to 27, 2004.

Address correspondence to Steven E. Wolf, MD, Brooke Army Medical Center/ US Army Institute for Surgical Research, 3400 Rawley E. Chambers Drive, San Antonio, Texas 78251.

© 2006 The American Burn Association