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Completed

NCT Number: NCT01698372

Negative Pressure Dressing After Saphenous Vein Harvest

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Complication of Coronary Artery Bypass Graft Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases Wound Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Libin Cardiovascular Institute, Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prevena device (Group A)

Device

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

Other names: Prevena Incision Management System, Prevena 125, PRE1001.S Prevena Incision Kit

Primary outcomes

  1. Change from baseline ASEPSIS score of wound healing at 6 weeks.

    Time frame: 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 outcomes

  1. Total score of pain level.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • KCI USA, Inc

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Oct 3, 2012
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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