Negative Pressure Dressing After Saphenous Vein Harvest

Coronary Artery Disease Clinical Trial

Official title:

Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698372
• Other study ID #: KCI VAC Study
• 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

• Complication of Coronary Artery Bypass Graft
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Wound Complication

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