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| Name | Class |
|---|---|
| KCI USA, Inc | INDUSTRY |
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This study will test the effectiveness of negative pressure wound therapy (using the VAC Prevena device, KCI Canada Inc.) applied to the saphenous vein harvest site after Coronary Artery Bypass Grafting (CABG). When initiated immediately after surgery, this intervention may decrease the incidence of wound infection and non-infectious wound complications. It may decrease wound discomfort and improve mobility and functional recovery of the leg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevena device (Group A) | Experimental | Group A will have the VAC Prevena portable device applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery. |
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| Conventional dressing (Group B) | No Intervention | Group B will have conventional dry dressing applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevena device (Group A) | Device | This portable device is applied to initiate negative pressure therapy to a wound site. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline ASEPSIS score of wound healing at 6 weeks. | The ASEPSIS quantitative wound scoring method will be used to assess patients' leg wound healing after saphenous vein harvesting for coronary artery bypass surgery. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total score of pain level. | Patients will be asked to evaluate the level of pain (using the Leg Incision Assessment Form) at the wound site after saphenous vein harvesting. | Baseline and 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Fedak, MD, PhD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Libin Cardiovascular Institute, Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28025309 | Derived | Lee AJ, Sheppard CE, Kent WD, Mewhort H, Sikdar KC, Fedak PW. Safety and efficacy of prophylactic negative pressure wound therapy following open saphenous vein harvest in cardiac surgery: a feasibility study. Interact Cardiovasc Thorac Surg. 2017 Mar 1;24(3):324-328. doi: 10.1093/icvts/ivw400. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |