Clinical trial NCT02453945: Use of a Support Bra to Reduce Pain and Improve Surgical Healing in Women Undergoing Sternotomy for Cardiac Surgery
Official title: Use of a Support Bra to Reduce Pain and Improve Surgical Healing in Women Undergoing Sternotomy for Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Disruption or Dehiscence of Closure of Sternum or Sternotomy
Quality of Life
Keywords: pain
comfort
healing
quality of life
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Medbuy Pharmacy
First posted: 2015-05-27
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Pain - Visual Analog Scale
timeFrame: Post-operative period (approximately 5-7days),
measure: Pain - Visual Analog Scale
timeFrame: 6 weeks
measure: Pain - Pt questionnaire
timeFrame: 6 months after surgery
measure: Pain - Patient questionnaire
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Comfort - Patient Questionaires
timeFrame: Post-operative period in hospital (approximately 5-7days)
measure: Comfort - Patient Questionaires
timeFrame: 6-week post-op visit
measure: Comfort - Patient Questionaires
timeFrame: 6-months
measure: Comfort - Patient Questionaires
timeFrame: 1-year
measure: Sternal Wound Dehiscence - Medical Documentation in chart
timeFrame: In hospital post-operative period (approximately 5-7days).
measure: Quality of life pre cardiac surgery - Lawton ADL (Activity of daily living) scale
timeFrame: Pre-op
measure: Quality of life pre cardiac surgery - SF12
timeFrame: Pre-op
measure: Quality of life post cardiac surgery - Lawton ADL (Activity of daily living) scale
timeFrame: 6 months
measure: Quality of life post cardiac surgery - SF12
timeFrame: 6 months
measure: Quality of life post cardiac surgery - Lawton ADL (activity of daily living) scale
timeFrame: 1 year
measure: Quality of life post cardiac surgery - SF12
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St Michael
state: Ontario
Study officials:
References: