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| Name | Class |
|---|---|
| Medbuy Pharmacy | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medical Support Bra | Experimental | ClearPoint Medical Support Bra worn by patients during their post-cardiac surgery hospital stay (approximately 5-7days). |
|
| Control | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjustable Support Bra | Device | A ClearPoint Medical support bra |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Comfort - Patient Questionaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alison Carre, RN | Contact | 4168646060 | ||
| Alison Carre | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Michael | Recruiting | Toronto | Ontario | W3R 5Y6 | Canada |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| 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 |
| 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 |
| 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). |
| 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 |
| 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 |
| Quality of life post cardiac surgery - Lawton ADL (Activity of daily living) scale | 6 months |
| Quality of life post cardiac surgery - SF12 | 6 months |
| Quality of life post cardiac surgery - Lawton ADL (activity of daily living) scale | 1 year |
| Quality of life post cardiac surgery - SF12 | 1 year |