Coronary Artery Disease Clinical Trial
Official title:
Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG
Verified date | November 2015 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | March 2015 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients presenting for elective or semi-elective isolated first-time CABG surgery with harvesting of the greater saphenous vein. - Must be 18 years or older. - Must live with one hour driving distance from Calgary. - Must provide written consent. Exclusion Criteria: - Previous CABG surgery or previous lower leg surgical intervention. - In emergent need for surgery. - Have severe peripheral vascular disease. - Do not speak and read the English language. - Have dialysis-dependent renal failure. - Require chronic steroids. - Unable to return to clinic for follow-up due to functional or cognitive impairment. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Canada | Libin Cardiovascular Institute, Foothills Medical Centre | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | KCI USA, Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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 | No |
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