ABSTRACT
BACKGROUND: Anabolic steroids have been reported to improve wound healing. OBJECTIVE: To determine whether oxandrolone increases the percentage of target pressure ulcers (TPUs) that heal compared with placebo and whether healed ulcers remain closed 8 weeks after treatment. DESIGN: Parallel-group, placebo-controlled, randomized trial conducted from 1 August 2005 to 30 November 2008. Patients, clinical care providers, study personnel, and statisticians were blinded to treatment assignment. (ClinicalTrials.gov: NCT00101361). SETTING: 16 inpatient spinal cord injury (SCI) services at Veterans Affairs medical centers. PATIENTS: 1900 prescreened, 779 screened, and 212 randomly assigned inpatients with SCI and stage III or IV TPUs. INTERVENTION: Oxandrolone, 20 mg/d (n = 108), or placebo (n = 104) until the TPU healed or 24 weeks. MEASUREMENTS: The primary outcome was healed TPUs. The secondary outcome was the percentage of TPUs that remained healed at 8-week follow-up. RESULTS: 24.1% (95% CI, 16.0% to 32.1%) of TPUs in oxandrolone recipients and 29.8% (CI, 21.0% to 38.6%) in placebo recipients healed (difference, -5.7 percentage points [CI, -17.5 to 6.8 percentage points]; P = 0.40). At 8-week follow-up, 16.7% (CI, 9.6% to 23.7%) of oxandrolone recipients and 15.4% (CI, 8.5% to 22.3%) of placebo recipients retained a healed TPU (difference, 1.3 percentage points [CI, -8.8 to 11.2 percentage points]; P = 0.70). No serious adverse events were related to oxandrolone. Liver enzyme levels were elevated in 32.4% (CI, 23.6% to 41.2%) of oxandrolone recipients and 2.9% (CI, 0.0% to 6.1%) of placebo recipients (P < 0.001). LIMITATIONS: Selection of severe wounds may have reduced treatment response. Approximately one third of patients did not complete the study in the treatment and placebo groups. The study was terminated after a futility analysis showed a low probability of detecting a significant difference between the groups. CONCLUSION: Oxandrolone showed no benefit over placebo for improving healing or the percentage of TPUs that remained closed after 8 weeks of treatment. PRIMARY FUNDING SOURCE: U.S. Department of Veterans Affairs.
Subject(s)
Anabolic Agents/therapeutic use , Oxandrolone/therapeutic use , Pressure Ulcer/drug therapy , Spinal Cord Injuries/complications , Wound Healing/drug effects , Aged , Anabolic Agents/adverse effects , Female , Humans , Liver/enzymology , Male , Middle Aged , Oxandrolone/adverse effects , Prealbumin/metabolism , Pressure Ulcer/complications , Treatment OutcomeABSTRACT
BACKGROUND/OBJECTIVE: The insufflator-exsufflator has been shown to be effective in assisting cough in individuals with spinal cord injury. However, many institutions do not use this device. The study was performed to assess use of the device and attitudes among health care providers. METHODS: We developed a questionnaire with 4 categories of questions: knowledge of the device, type of facility, clinical practice with the device, and patient and provider satisfaction. The questionnaire was mailed to members of the American Paraplegia Society. RESULTS: Eighty-six questionnaires (16%) were returned. The device was being used in 49% of the institutions. The device was most commonly used with a tracheostomy; use did not correlate with size or type of facility. Patient and provider satisfaction with the insufflator-exsufflator was high. CONCLUSIONS: The insufflator-exsufflator is used as a means of removal of secretions in approximately one half of institutions polled. Satisfaction with the device is high.
