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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
140
A ClearPoint Medical support bra
St Michael
Toronto, Ontario, Canada
RECRUITINGPain - 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.
Time frame: Post-operative period (approximately 5-7days),
Pain - Visual Analog Scale
6-week post-op visit
Time frame: 6 weeks
Pain - Pt questionnaire
Time frame: 6 months after surgery
Pain - Patient questionnaire
Time frame: 1 year after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Alison Carre
CONTACT
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Time frame: 1-year
Sternal Wound Dehiscence - Medical Documentation in chart
Patients will be tracked during their hospital stay (approximately 5-7days) for sternal wound complications.
Time frame: 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.
Time frame: 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.
Time frame: Pre-op
Quality of life post cardiac surgery - Lawton ADL (Activity of daily living) scale
Time frame: 6 months
Quality of life post cardiac surgery - SF12
Time frame: 6 months
Quality of life post cardiac surgery - Lawton ADL (activity of daily living) scale
Time frame: 1 year
Quality of life post cardiac surgery - SF12
Time frame: 1 year