The MCTG ‘s first prospective randomized trial was completed in 2003. This study involved 17 burn centers from across the U.S. The abstract was presented at the ABA 2004 meeting and a manuscript is in process.

Severe burns induce a number of pathophysiologic deficits, among them catabolism of lean mass with resultant weakness and prolonged wound healing. These deficits then lead to protracted hospitalizations to affect recovery. Oxandrolone is an anabolic agent, which has been shown to decrease lean mass catabolism and improve wound healing in the severely burned. We performed a rigorous multi-center double-blind prospective randomized clinical trial testing the effects of Oxandrolone treatment on length of hospital stay among other clinical outcomes. We planned to enroll 150 subjects between 18 and 70 years of age with burns between 20 and 60% TBSA requiring at least one excision and grafting operation, randomized between Oxandrolone 10mg BID every 12 hours or placebo beginning five days into hospitalization. Length of hospital stay was used as the primary outcome indicator. At the interim analysis, we found a significant difference in total length of hospitalization and length of hospitalization/% TBSA burn in favor of Oxandrolone treatment (see table).

We conclude that oxandrolone treatment benefits the severely burned shown here for the first time with level I evidence. Further analysis of subgroups and secondary outcome measures are pending.