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

• Sponsor: Unity Health Toronto (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02453945
• Collaborator: Medbuy Pharmacy (Other)
• Enrollment: 140
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 49
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Disruption or Dehiscence of Closure of Sternum or Sternotomy; Quality of Life	Device: Adjustable Support Bra	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Use of a Support Bra to Reduce Pain and Improve Surgical Healing in Women Undergoing Sternotomy for Cardiac Surgery
• Actual Study Start Date: Nov 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: Control Usual Care

Outcome Measures

Primary Outcome Measures

1. Pain - Visual Analog Scale [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.

2. Pain - Visual Analog Scale [6 weeks]

   6-week post-op visit

3. Pain - Pt questionnaire [6 months after surgery]

4. Pain - Patient questionnaire [1 year after surgery]

Secondary Outcome Measures

1. Comfort - Patient Questionaires [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.

2. Comfort - Patient Questionaires [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.

3. Comfort - Patient Questionaires [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.

4. Comfort - Patient Questionaires [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.

5. Sternal Wound Dehiscence - Medical Documentation in chart [In hospital post-operative period (approximately 5-7days).]

   Patients will be tracked during their hospital stay (approximately 5-7days) for sternal wound complications.

6. Quality of life pre cardiac surgery - Lawton ADL (Activity of daily living) scale [Pre-op]

   Patients will be assessed pre-op, at 6-months after surgery and again at the 1 year point.

7. Quality of life pre cardiac surgery - SF12 [Pre-op]

   Patients will be assessed pre-op, at 6-months after surgery and again at the 1 year point.

8. Quality of life post cardiac surgery - Lawton ADL (Activity of daily living) scale [6 months]

9. Quality of life post cardiac surgery - SF12 [6 months]

10. Quality of life post cardiac surgery - Lawton ADL (activity of daily living) scale [1 year]

11. Quality of life post cardiac surgery - SF12 [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Michael	Toronto	Ontario	Canada	W3R 5Y6

Sponsors and Collaborators

• Unity Health Toronto
• Medbuy Pharmacy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT02453945
• Other Study ID Numbers: R.E.B. number: 15-144
• First Posted: May 27, 2015
• Last Update Posted: Nov 1, 2019
• Last Verified: Oct 1, 2019

• Keywords provided by Unity Health Toronto: pain; comfort; healing; quality of life

Study Results

No Results Posted as of Nov 1, 2019