The Women's Recovery from Sternotomy (WREST) Study: Design of a randomized trial of a novel undergarment for early use after sternotomy

King, Kathryn M.; Tsuyuki, Ross; Faris, Peter; Currie, Gillian; Maitland, Andrew; Collins-Nakai, Ruth

doi:10.1016/j.ahj.2004.08.011

« Previous Next »American Heart Journal
Volume 149, Issue 5 , Pages 761-767, May 2005

The Women's Recovery from Sternotomy (WREST) Study: Design of a randomized trial of a novel undergarment for early use after sternotomy

Kathryn M. King, RN, PhD
- Faculty of Nursing, University of Calgary, Calgary, Alberta, Canada
- Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
- Reprint requests: Kathryn M. King, RN, PhD, Faculty of Nursing, University of Calgary, 2500 University Dr, NW, Calgary, Alberta, Canada T2N 1N4.
Ross Tsuyuki, MSc, PharmD
- EPICORE Center, Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada
Peter Faris, PhD
- Centre for Advancement of Health, Calgary Health Region, Calgary, Alberta, Canada
Gillian Currie, PhD
- Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada
- Department of Economics, University of Calgary, Calgary, Alberta, Canada
Andrew Maitland, MB, FRCSC, FACS
- Department of Surgery, University of Calgary, Calgary, Alberta, Canada
- Department of Cardiothoracic Surgery, Calgary Health Region, Calgary, Alberta, Canada
Ruth Collins-Nakai, MD, MBA, FRCPC, FACC
- University of Alberta Hospital, Capital Health Region, Edmonton, Alberta, Canada

Received 20 April 2004; accepted 10 August 2004.

Background

Clinicians who work with women poststernotomy often suggest that they wear a supportive brassiere to ameliorate pain, discomfort, and potential wound complications. There is no empirical evidence that supports this practice.

Methods

Despite methodological challenges, a clinical trial is currently underway to investigate the efficacy of early use of a novel undergarment after sternotomy. Women (N = 430) having first time sternotomy in 9 Canadian centers will be randomized to receive either the usual care of the institution or early use of a novel undergarment. Follow-up is planned over 12 postoperative weeks. Coprimary outcomes are pain, discomfort, and return to function. Wound healing is a secondary outcome. An economic evaluation substudy is also underway.

Conclusions

The WREST Study is a unique ongoing trial examining the efficacy of a novel undergarment in reducing women's pain and enhancing their comfort and return to function. The findings of the trial and its economic substudy will enable health care providers to make rational evidence-based clinical decisions regarding women's early care after sternotomy.