Prevena Incision Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-13

Study Completion Date

2020-02-09

Brief Summary

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The question this research project wants to explore is whether using the Prevena Incision Management System (Prevena) will improve sternal wound edge oxygenation in patients undergoing Coronary Artery bypass surgery with Bilateral Internal Mammary Artery grafts.

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Detailed Description

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Coronary artery bypass is the gold standard surgical treatment of patients with complex coronary disease. It is a common operation and more than 16000 procedures per year are carried out in the UK. Recent publications suggest that during the bypass procedure both left and right internal mammary arteries should be used to bypass coronary stenoses. It was noted that using both internal mammary arteries will result in even better long term survival with improved freedom from cardiac events such as myocardial infarction or further coronary intervention than using. The major drawback of using both internal mammary arteries is the increased risk of sternal wound infection and breakdown. The investigators will use Near Infra-Red Spectroscopy (NIRS) to assess the wound edge oxygenation delivery. The NIRS INVOS system the investigators use within Sheffield Teaching Hospitals can measure oxygenation of soft tissue to a certain depth making it suitable for the assessment of wound edge oxygen delivery. Prevena is commercially available and has a CE mark.

The Prevena wound management system differs from conventional wound dressings, it applies negative pressure to the closed wound for 7 days. Wound complications/infections are decreased when this type of wound management system is used. Studies suggest that Prevena achieves these outcomes because of an increase of perfusion in the wound edges and keeping the wound dry. Patients will be randomised to either the Prevena wound management or their standard of care NHS wound management for their procedure. The oxygenation and outcomes of the wounds will be compared through data collection and the patients followed up during their routine inpatient care and 6 week outpatient appointment.

Conditions

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Cardiac Event Arrest; Cardiac, Complicating Surgery Coronary Bypass Graft Stenosis Complication of Coronary Artery Bypass Graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bilateral Internal Mammary Artery grafts

Standard care wound dressings used as part of coronary artery bypass graft operation

Group Type ACTIVE_COMPARATOR

Bilateral Internal Mammary Artery grafts

Intervention Type DEVICE

Sternal Wound Edge Oxygenation in patients undergoing Coronary Artery bypass surgery with Bilateral Internal Mammary Artery grafts

Prevena

Prevena dressing used as part of coronary artery bypass graft operation.

Group Type EXPERIMENTAL

Prevena

Intervention Type DEVICE

The Prevena wound management system applies negative pressure to the closed wound for up to 7 days and is associated with lower rates of surgical site infection.

Interventions

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Bilateral Internal Mammary Artery grafts

Sternal Wound Edge Oxygenation in patients undergoing Coronary Artery bypass surgery with Bilateral Internal Mammary Artery grafts

Intervention Type DEVICE

Prevena

The Prevena wound management system applies negative pressure to the closed wound for up to 7 days and is associated with lower rates of surgical site infection.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Eligible patients are those who require isolated coronary artery bypass surgery, who need at least 2 bypass grafts, and who are deemed suitable by the operating surgeon to have both right and left internal mammary arteries harvested as conduits

Exclusion Criteria

* Require additional procedures in addition to the coronary bypass or need for internal mammary artery harvest for feasibility study
* Who are deemed by the operating surgeon as unsuitable for bilateral internal mammary artery harvest because of
* Age (75 or older where prognostic benefit of using both internal mammary arteries has been questioned),
* Obesity with a BMI which is higher than 35 (increased risks of wound infection)
* Diabetes (of any type) (increased risks of infection.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No