The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury: a randomized trial.

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.

Epidemiology of hospital-acquired infections in veterans with spinal cord injury and disorder.

OBJECTIVE: To describe the epidemiology of hospital-acquired infections (HAIs) in veterans with spinal cord injury and disorder (SCI&D). DESIGN: Retrospective medical record review. SETTING: Midwestern Department of Veterans Affairs spinal cord injury center. PARTICIPANTS: A total of 226 patients with SCI&D hospitalized at least once during a 2-year period (October 1, 2001, through September 30, 2003). RESULTS: A total of 549 hospitalizations were included in the analysis (mean duration of hospitalization, 33.7 days); an HAI occurred during 182 (33.2%) of these hospitalizations. A total of 657 HAIs occurred during 18,517 patient-days in the hospital (incidence rate, 35.5 HAIs per 1,000 patient-days). Almost half of the 226 patients had at least 1 HAI; the mean number of HAIs among these patients was 6.0 HAIs per patient. The most common HAIs were urinary tract infection (164 [25.0%] of the 657 HAIs; incidence rate, 8.9 cases per 1,000 patient-days), bloodstream infection (111 [16.9%]; incidence rate, 6.0 cases per 1,000 patient-days), and bone and joint infection (103 [15.7%]; incidence rate, 5.6 cases per 1,000 patient-days). The most common culture isolates were gram-positive bacteria (1,082 [45.6%] of 2,307 isolates), including Staphylococcus aureus, and gram-negative bacteria (1,033 [43.6%] of isolates), including Pseudomonas aeruginosa. Multivariable regression demonstrated that predictors of HAI were longer length of hospital stay (P=.002), community-acquired infection (P=.007), and use of a urinary invasive device (P=.01) or respiratory invasive device (P=.04). CONCLUSIONS: The overall incidence of HAIs in persons with SCI&D was higher than that reported for other populations, confirming the increased risk of HAI in persons with spinal cord injury. The increased risk associated with longer length of stay and with community-acquired infection suggests that strategies are needed to reduce the duration of hospitalization and to effectively treat community-acquired infection, to decrease infection rates. There is significant room for improvement in reducing the incidence of HAIs in this population.

Is there an association between athletic amenorrhea and endothelial cell dysfunction?

PURPOSE: To test the hypothesis that young females with athletic amenorrhea and oligomenorrhea show signs of early cardiovascular disease manifested by decreased endothelium-dependent dilation of the brachial artery. METHODS: Ten women with athletic amenorrhea (mean +/- SE, age 21.9 +/- 1.2 yr), 11 with oligomenorrhea (age 20.8 +/- 1.1 yr), and 11 age-matched controls (age 20.2 +/- 1.1 yr) were studied. Study subjects were amenorrheic an average of 2.3 (range 0.6-5) yr and oligomenorrheic an average of 6.2 yr. All ran a minimum of 25 miles.wk. They were nonpregnant and free of metabolic disease. Brachial artery flow-mediated dilation (endothelium-dependent) was measured with a noninvasive ultrasound technique in each group. RESULTS: Endothelium-dependent brachial artery dilation was reduced in the amenorrheic group (1.08 +/- 0.91%) compared with oligomenorrheic (6.44 +/- 1.3%; P< 0.05) and eumenorrheic (6.38 +/- 1.4%; P< 0.05) groups. CONCLUSION: Athletic amenorrhea is associated with reduced endothelium-dependent dilation of the brachial artery. This may predispose to accelerated development of cardiovascular disease.