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| Name | Class |
|---|---|
| St. Paul's Hospital, Canada | OTHER |
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The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual closure | Active Comparator | Patients are closed with a manual, straight wire, conventional closure technique |
|
| TORQ closure | Active Comparator | Patients are undergo a TORQ assisted sternal closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TORQ assisted sternal closure | Procedure |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory function | Pre-op, 2 and 4 days Post-op | |
| Pain Score | Patient reported pain on a scale of 1 to 10 for breathing, coughing and walking | 2, 4, 14, 30 and 90 days post op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Abel, MD | St. Paul's Hospital, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
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| Conventional closure |
| Procedure |
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