The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury

William A. Bauman, Ann M. Spungen, Joseph F. Collins, Dennis W. Raisch, Chester Ho, George A. Deitrick, Bernard A. Nemchausky, Lance L. Goetz, Jai S. Park, Michael Schwartz, John L. Merritt, Vidya Jayawardena, Paul Sandford, Sunil Sabharwal, Sally A. Holmes, Fahima Nasar, Roy Sasaki, Vandana Punj, Karin F. Zachow, Walter C. ChuaMarykutty D. Thomas, Rose C. Trincher

Research output: Contribution to journalArticle

21 Citations (Scopus)

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, 20mg/d(n108), or placebo (n104) 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 pla-cebo recipients healed (difference,5.7percentage points [CI, 17.5 to 6.8 percentage points]; P0.40). 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]; P0.70). 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 < 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.

Original languageEnglish
Pages (from-to)718-726
Number of pages9
JournalAnnals of Internal Medicine
Volume158
Issue number10
StatePublished - May 21 2013

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Oxandrolone
Pressure Ulcer
Spinal Cord Injuries
Placebos
Inpatients
Testosterone Congeners
Medical Futility
Therapeutics
Veterans
Wound Healing
Ulcer
Patient Care
Randomized Controlled Trials

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Bauman, W. A., Spungen, A. M., Collins, J. F., Raisch, D. W., Ho, C., Deitrick, G. A., ... Trincher, R. C. (2013). The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury. Annals of Internal Medicine, 158(10), 718-726.

The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury. / Bauman, William A.; Spungen, Ann M.; Collins, Joseph F.; Raisch, Dennis W.; Ho, Chester; Deitrick, George A.; Nemchausky, Bernard A.; Goetz, Lance L.; Park, Jai S.; Schwartz, Michael; Merritt, John L.; Jayawardena, Vidya; Sandford, Paul; Sabharwal, Sunil; Holmes, Sally A.; Nasar, Fahima; Sasaki, Roy; Punj, Vandana; Zachow, Karin F.; Chua, Walter C.; Thomas, Marykutty D.; Trincher, Rose C.

In: Annals of Internal Medicine, Vol. 158, No. 10, 21.05.2013, p. 718-726.

Research output: Contribution to journalArticle

Bauman, WA, Spungen, AM, Collins, JF, Raisch, DW, Ho, C, Deitrick, GA, Nemchausky, BA, Goetz, LL, Park, JS, Schwartz, M, Merritt, JL, Jayawardena, V, Sandford, P, Sabharwal, S, Holmes, SA, Nasar, F, Sasaki, R, Punj, V, Zachow, KF, Chua, WC, Thomas, MD & Trincher, RC 2013, 'The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury', Annals of Internal Medicine, vol. 158, no. 10, pp. 718-726.
Bauman WA, Spungen AM, Collins JF, Raisch DW, Ho C, Deitrick GA et al. The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury. Annals of Internal Medicine. 2013 May 21;158(10):718-726.
Bauman, William A. ; Spungen, Ann M. ; Collins, Joseph F. ; Raisch, Dennis W. ; Ho, Chester ; Deitrick, George A. ; Nemchausky, Bernard A. ; Goetz, Lance L. ; Park, Jai S. ; Schwartz, Michael ; Merritt, John L. ; Jayawardena, Vidya ; Sandford, Paul ; Sabharwal, Sunil ; Holmes, Sally A. ; Nasar, Fahima ; Sasaki, Roy ; Punj, Vandana ; Zachow, Karin F. ; Chua, Walter C. ; Thomas, Marykutty D. ; Trincher, Rose C. / The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury. In: Annals of Internal Medicine. 2013 ; Vol. 158, No. 10. pp. 718-726.
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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, 20mg/d(n108), or placebo (n104) 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 pla-cebo recipients healed (difference,5.7percentage points [CI, 17.5 to 6.8 percentage points]; P0.40). 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]; P0.70). 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 < 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.",
author = "Bauman, {William A.} and Spungen, {Ann M.} and Collins, {Joseph F.} and Raisch, {Dennis W.} and Chester Ho and Deitrick, {George A.} and Nemchausky, {Bernard A.} and Goetz, {Lance L.} and Park, {Jai S.} and Michael Schwartz and Merritt, {John L.} and Vidya Jayawardena and Paul Sandford and Sunil Sabharwal and Holmes, {Sally A.} and Fahima Nasar and Roy Sasaki and Vandana Punj and Zachow, {Karin F.} and Chua, {Walter C.} and Thomas, {Marykutty D.} and Trincher, {Rose C.}",
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T1 - The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury

AU - Bauman, William A.

AU - Spungen, Ann M.

AU - Collins, Joseph F.

AU - Raisch, Dennis W.

AU - Ho, Chester

AU - Deitrick, George A.

AU - Nemchausky, Bernard A.

AU - Goetz, Lance L.

AU - Park, Jai S.

AU - Schwartz, Michael

AU - Merritt, John L.

AU - Jayawardena, Vidya

AU - Sandford, Paul

AU - Sabharwal, Sunil

AU - Holmes, Sally A.

AU - Nasar, Fahima

AU - Sasaki, Roy

AU - Punj, Vandana

AU - Zachow, Karin F.

AU - Chua, Walter C.

AU - Thomas, Marykutty D.

AU - Trincher, Rose C.

PY - 2013/5/21

Y1 - 2013/5/21

N2 - 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, 20mg/d(n108), or placebo (n104) 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 pla-cebo recipients healed (difference,5.7percentage points [CI, 17.5 to 6.8 percentage points]; P0.40). 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]; P0.70). 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 < 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.

AB - 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, 20mg/d(n108), or placebo (n104) 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 pla-cebo recipients healed (difference,5.7percentage points [CI, 17.5 to 6.8 percentage points]; P0.40). 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]; P0.70). 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 < 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.

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