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Prevena device (Group A) for Coronary Artery Disease

Phase 1
Waitlist Available
Led By Paul Fedak, MD, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 weeks
Awards & highlights

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.

Eligible Conditions
  • Coronary Artery Disease
  • Coronary Artery Bypass
  • Wound Complications

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline ASEPSIS score of wound healing at 6 weeks.
Secondary outcome measures
Total score of pain level.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prevena device (Group A)Experimental Treatment1 Intervention
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.
Group II: Conventional dressing (Group B)Active Control1 Intervention
Group B will have conventional dry dressing applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prevena device (Group A)
2012
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
800 Previous Clinical Trials
875,106 Total Patients Enrolled
11 Trials studying Coronary Artery Disease
10,732 Patients Enrolled for Coronary Artery Disease
3MIndustry Sponsor
157 Previous Clinical Trials
31,410 Total Patients Enrolled
Paul Fedak, MD, PhDPrincipal InvestigatorUniversity of Calgary
~5 spots leftby Jul 2025
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