Negative Pressure Dressing After Saphenous Vein Harvest

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01698372

Enrollment

Registered

2012-10-03

Start date

2012-09-30

Completion date

2015-03-31

Last updated

2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

DEVICEPrevena device (Group A)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026