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

Study Overview
=================
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.

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

Conditions
-----------------
Pain, Disruption or Dehiscence of Closure of Sternum or Sternotomy, Quality of Life

Intervention / Treatment
-----------------
* Device: Adjustable Support Bra


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain - Visual Analog Scale | 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 | 6-week post-op visit | 6 weeks | 
| Pain - Pt questionnaire |  | 6 months after surgery | 
| Pain - Patient questionnaire |  | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort - Patient Questionaires | 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 | 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 | 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 | 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 | 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 | 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 | 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 |  | 6 months | 
| Quality of life post cardiac surgery - SF12 |  | 6 months | 
| Quality of life post cardiac surgery - Lawton ADL (activity of daily living) scale |  | 1 year | 
| Quality of life post cardiac surgery - SF12 |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, comfort, healing, quality of life