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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02453945
• Other study ID #: R.E.B. number: 15-144
• Status: Recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2019

Study information

• Verified date: October 2019
• Source: St. Michael's Hospital, Toronto
• Contact: Alison Carre, RN
• Phone: 4168646060
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Adjustable Support Bra
A ClearPoint Medical support bra

Locations

Country	Name	City	State
Canada	St Michael	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Medbuy Pharmacy

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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),
Primary	Pain - Visual Analog Scale	6-week post-op visit	6 weeks
Primary	Pain - Pt questionnaire		6 months after surgery
Primary	Pain - Patient questionnaire		1 year after surgery
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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).
Secondary	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
Secondary	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
Secondary	Quality of life post cardiac surgery - Lawton ADL (Activity of daily living) scale		6 months
Secondary	Quality of life post cardiac surgery - SF12		6 months
Secondary	Quality of life post cardiac surgery - Lawton ADL (activity of daily living) scale		1 year
Secondary	Quality of life post cardiac surgery - SF12		1 year