NCT02453945

Use of a Support Bra to Reduce Pain and Improve Surgical Healing in Women Undergoing Sternotomy for Cardiac Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to examine whether a properly fitted support bra on females improves their quality of life post-sternotomy. Specifically, does a support bra reduce discomfort, pain and wound dehiscence.

Detailed description

Participants will be randomized to one arm of the study. One group will be fitted for a support bra and will be asked to wear this bra 24 hours a day for their 6 week post-course. They will submit to 3 questionnaires (at hospital discharge, at 3 weeks post-op and at their 6 week post-op visit with their surgeon. They will diary over this 6 week period re: pain, comfort, wound healing. The group in the no bra arm will also be measured for breast size and will submit to 3 questionnaires (at the same intervals) and will be asked to diary over their 6 week post-op course re: pain, comfort, wound healing. Chronic pain and quality of life markers will be assessed through a 6month and 1 year follow-up telephone call and questionnaire.

Conditions

• Pain
• Disruption or Dehiscence of Closure of Sternum or Sternotomy
• Quality of Life

Interventions

Type	Name	Description
DEVICE	Adjustable Support Bra	A ClearPoint Medical support bra

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2015-05-27
• Last updated: 2019-11-01

Locations

1 site across 1 country: Canada