MedicalResearch.com eInterview with   Dr. William A. Bauman, MD Veterans Affairs Rehabilitation Research and Development National Center of Excellence for the Medical Consequences of Spinal Cord Injury Suite 7A-13, James J. Peters Veterans Affairs Medical Center 130 West Kingsbridge Road, Bronx, NY 10468; MedicalResearch.com: What are the main findings of the study? Dr. Bauman: In a prospective, randomized two-group, double-blind, placebo-controlled, intention-to-treat clinical trial, we determined whether SCI in-patients with a full thickness (Stage III or IV) pressure ulcers of the pelvic region who received 24 weeks or less of optimized clinical care and an oral anabolic steroid agent, oxandrolone, have a greater percent of healed target pressure ulcers than those who received placebo and the same clinical care. There was no significant difference in proportion of pressure ulcers that healed between the treatment and placebo groups [treatment recipients 24.1% (95% CI, 16.0% to 32.1%) and placebo recipients 29.8% (CI, 21% to 38.6%) with a difference, -5.7 percentage points (CI, -17.5 to 6.8 percentage points)]. Also, the rate of healing of wounds at 28 days was not significantly different between the groups (50.9% of the oxandrolone group and 43.3% of the placebo group had healing of ≥30.0%), nor was the number of wounds that remained closed at 8 weeks significantly different (16.7% of the oxandrolone group and 15.4% of the placebo group). No serious adverse events were related to drug administration but a significantly greater proportion of patients had elevated liver enzymes in the treatment group [treatment recipients 32.4% (95% CI, 23.6% to 41.2%) and placebo recipients 2.9%% (CI, 0.0% to 6.1%). Thus, oxandrolone showed no benefit over placebo for improving healing of chronic pressure ulcers of the pelvic region or the proportion that remained closed after 8 weeks of treatment. (more…)