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

Not Applicable

• Conditions: Pain; Quality of Life; Disruption or Dehiscence of Closure of Sternum or Sternotomy
• Interventions: Device: Adjustable Support Bra

• Registration Number: NCT02453945
• Lead Sponsor: Unity Health Toronto

Brief 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.

Study Timeline

• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-27
• Study Start: 2015-11
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-01
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• Adult women (≥ 18 yrs) who are undergoing cardiac surgery with a sternotomy

Exclusion Criteria

• Patients who have had a previous mastectomy
• Previous radiotherapy to the chest
• Patients who do not read, write or have issues comprehending English
• Patients with cognitive impairments who will not be able to comply with the research study protocol
• Patients requiring physical restraints
• Patients requiring the application of a sternal binder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical Support Bra	Adjustable Support Bra	ClearPoint Medical Support Bra worn by patients during their post-cardiac surgery hospital stay (approximately 5-7days).

Primary Outcome Measures

Name	Time	Method
Pain - Pt questionnaire	6 months after surgery
Pain - Patient questionnaire	1 year after surgery
Pain - Visual Analog Scale	6 weeks	6-week post-op visit

Secondary Outcome Measures

Name	Time	Method
Quality of life post cardiac surgery - Lawton ADL (activity of daily living) scale	1 year
Comfort - Patient Questionaires	1-year	Patients will be tracked post-operatively during their hospital stay (approximately 5-7days), at their 6 week follow up visit, 6-months and 1-year after their surgery date.
Sternal Wound Dehiscence - Medical Documentation in chart	In hospital post-operative period (approximately 5-7days).	Patients will be tracked during their hospital stay (approximately 5-7days) for sternal wound complications.
Quality of life post cardiac surgery - Lawton ADL (Activity of daily living) scale	6 months
Quality of life post cardiac surgery - SF12	1 year
Quality of life pre cardiac surgery - SF12	Pre-op	Patients will be assessed pre-op, at 6-months after surgery and again at the 1 year point.
Quality of life pre cardiac surgery - Lawton ADL (Activity of daily living) scale	Pre-op	Patients will be assessed pre-op, at 6-months after surgery and again at the 1 year point.

Trial Locations

Locations (1)

St Michael; 🇨🇦 Toronto, Ontario, Canada