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

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 womenʹs 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 womenʹs early care after sternotomy.