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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Medical Support Bra

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

Group Type EXPERIMENTAL

Adjustable Support Bra

Intervention Type DEVICE

A ClearPoint Medical support bra

Control

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adjustable Support Bra

A ClearPoint Medical support bra

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes