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

Last updated: October 31, 2019
Sponsor: St. Michael's Hospital, Toronto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Treatment

N/A

Clinical Study ID

NCT02453945
R.E.B. number: 15-144
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 researchstudy protocol

  • Patients requiring physical restraints

  • Patients requiring the application of a sternal binder

Study Design

Total Participants: 140
Study Start date:
November 01, 2015
Estimated Completion Date:
December 31, 2019

Study 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.

Connect with a study center

  • St Michael

    Toronto, Ontario W3R 5Y6
    Canada

    Active - Recruiting

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