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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01698372
Other study ID # KCI VAC Study
Secondary ID
Status Completed
Phase Phase 1
First received September 18, 2012
Last updated November 30, 2015
Start date September 2012
Est. completion date March 2015

Study information

Verified date November 2015
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Device:
Prevena device (Group A)
This portable device is applied to initiate negative pressure therapy to a wound site.

Locations

Country Name City State
Canada Libin Cardiovascular Institute, Foothills Medical Centre Calgary Alberta

Sponsors (2)

Lead Sponsor Collaborator
University of Calgary KCI USA, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

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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