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Negative Pressure Dressing After Saphenous Vein Harvest

Primary Purpose

Coronary Artery Disease, Complication of Coronary Artery Bypass Graft, Wound Complication

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Prevena device (Group A)
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease focused on measuring Cardiac surgery., Wound healing., Leg wound infection., Wound care.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Libin Cardiovascular Institute, Foothills Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prevena device (Group A)

Conventional dressing (Group B)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 18, 2012
Last Updated
November 30, 2015
Sponsor
University of Calgary
Collaborators
3M
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1. Study Identification

Unique Protocol Identification Number
NCT01698372
Brief Title
Negative Pressure Dressing After Saphenous Vein Harvest
Official Title
Negative Pressure Dressing to Decrease the Incidence of Leg Wound Complications After CABG
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
3M

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Complication of Coronary Artery Bypass Graft, Wound Complication
Keywords
Cardiac surgery., Wound healing., Leg wound infection., Wound care.

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prevena device (Group A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional dressing (Group B)
Arm Type
No Intervention
Arm Description
Group B will have conventional dry dressing applied to the saphenous vein harvest site after standard wound closure following coronary artery bypass surgery.
Intervention Type
Device
Intervention Name(s)
Prevena device (Group A)
Other Intervention Name(s)
Prevena Incision Management System, Prevena 125, PRE1001.S Prevena Incision Kit
Intervention Description
This portable device is applied to initiate negative pressure therapy to a wound site.
Primary Outcome Measure Information:
Title
Change from baseline ASEPSIS score of wound healing at 6 weeks.
Description
The ASEPSIS quantitative wound scoring method will be used to assess patients' leg wound healing after saphenous vein harvesting for coronary artery bypass surgery.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Total score of pain level.
Description
Patients will be asked to evaluate the level of pain (using the Leg Incision Assessment Form) at the wound site after saphenous vein harvesting.
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Fedak, MD, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Libin Cardiovascular Institute, Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28025309
Citation
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.
Results Reference
derived

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Negative Pressure Dressing After Saphenous Vein Harvest

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