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

October 31, 2019 updated by: Unity Health Toronto
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alison Carre, RN
  • Phone Number: 4168646060

Study Contact Backup

  • Name: Alison Carre

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, W3R 5Y6
        • Recruiting
        • St Michael
        • Contact:
          • Alison Carre, RN
          • Phone Number: 416-864-6060
          • Email: carrem@smh.ca
        • Contact:
          • Alison Carre, RN
          • Phone Number: 416-864-6060
        • Principal Investigator:
          • Alison Carre, RN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual Care
Experimental: Medical Support Bra
ClearPoint Medical Support Bra worn by patients during their post-cardiac surgery hospital stay (approximately 5-7days).
Device: Adjustable Support Bra
A ClearPoint Medical support bra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain - Visual Analog Scale
Time Frame: Post-operative period (approximately 5-7days),
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.
Post-operative period (approximately 5-7days),
Pain - Visual Analog Scale
Time Frame: 6 weeks
6-week post-op visit
6 weeks
Pain - Pt questionnaire
Time Frame: 6 months after surgery
6 months after surgery
Pain - Patient questionnaire
Time Frame: 1 year after surgery
1 year after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

Medbuy Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Actual)

November 1, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R.E.B. number: 15-144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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