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

Unity Health Toronto

Status

Unknown

Conditions

Quality of Life

Disruption or Dehiscence of Closure of Sternum or Sternotomy

Pain

Treatments

Device: Adjustable Support Bra

Study type

Interventional

Funder types

Other

Identifiers

NCT02453945

R.E.B. number: 15-144

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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