Use of a Support Bra to Reduce Pain and Improve Surgical Healing in Women Undergoing Sternotomy for Cardiac Surgery
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Nov 2015
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedNovember 1, 2019
October 1, 2019
4.1 years
February 19, 2015
October 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (11)
Comfort - Patient Questionaires
Post-operative period in hospital (approximately 5-7days)
Comfort - Patient Questionaires
6-week post-op visit
Comfort - Patient Questionaires
6-months
Comfort - Patient Questionaires
1-year
Sternal Wound Dehiscence - Medical Documentation in chart
In hospital post-operative period (approximately 5-7days).
- +6 more secondary outcomes
Study Arms (2)
Medical Support Bra
EXPERIMENTALClearPoint Medical Support Bra worn by patients during their post-cardiac surgery hospital stay (approximately 5-7days).
Control
NO INTERVENTIONUsual Care
Interventions
Eligibility Criteria
You may qualify if:
- Adult women (≥ 18 yrs) who are undergoing cardiac surgery with a sternotomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unity Health Torontolead
- Medbuy Pharmacycollaborator
Study Sites (1)
St Michael
Toronto, Ontario, W3R 5Y6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Alison Carre
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2015
First Posted
May 27, 2015
Study Start
November 1, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
November 1, 2019
Record last verified: 2019-10