Negative Pressure Dressing After Saphenous Vein Harvest

Phase 1

Completed

• Conditions: Complication of Coronary Artery Bypass Graft; Wound Complication; Coronary Artery Disease
• Interventions: Device: Prevena device (Group A)

• Registration Number: NCT01698372
• Lead Sponsor: University of Calgary

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-18
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-03
• Primary Completion: 2014-11
• Study Completion: 2015-03
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prevena device (Group A)	Prevena device (Group A)	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline ASEPSIS score of wound healing at 6 weeks.	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Total score of pain level.	Baseline and 6 weeks	Patients will be asked to evaluate the level of pain (using the Leg Incision Assessment Form) at the wound site after saphenous vein harvesting.

Trial Locations

Locations (1)

Libin Cardiovascular Institute, Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada