NCT01698372

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1 coronary-artery-disease

Timeline
Completed

Started Sep 2012

Typical duration for phase_1 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

2.2 years

First QC Date

September 18, 2012

Last Update Submit

November 30, 2015

Conditions

Coronary Artery DiseaseComplication of Coronary Artery Bypass GraftWound Complication

Keywords

Cardiac surgery.Wound healing.Leg wound infection.Wound care.

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Total score of pain level.

    Baseline and 6 weeks

Study Arms (2)

Prevena device (Group A)

EXPERIMENTAL

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.

Device: Prevena device (Group A)

Conventional dressing (Group B)

NO INTERVENTION

Group B will have conventional dry dressing applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery.

Interventions

Prevena device (Group A)DEVICE

This portable device is applied to initiate negative pressure therapy to a wound site.

Also known as: Prevena Incision Management System, Prevena 125, PRE1001.S Prevena Incision Kit
Prevena device (Group A)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Libin Cardiovascular Institute, Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (1)

  • Lee AJ, Sheppard CE, Kent WD, Mewhort H, Sikdar KC, Fedak PW. Safety and efficacy of prophylactic negative pressure wound therapy following open saphenous vein harvest in cardiac surgery: a feasibility study. Interact Cardiovasc Thorac Surg. 2017 Mar 1;24(3):324-328. doi: 10.1093/icvts/ivw400.

    PMID: 28025309DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Paul Fedak, MD, PhD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 18, 2012

First Posted

October 3, 2012

Study Start

September 1, 2012

Primary Completion

November 1, 2014

Study Completion

March 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

CA(1)