Prevena Incision Management

Sheffield Teaching Hospitals NHS Foundation Trust80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Bilateral Internal Mammary Artery graftsDEVICE

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

PrevenaDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.)

Locations (1)

Sheffield Teaching Hospitals NHS FT

Sheffield, England, United Kingdom

Outcomes

Primary Outcomes

NIRS measurement of the inferior third of the parasternal region and left forearm assessment

NIRS assessment of the left forearm will also be performed at the same time acting as a control to take into account factors other than wound perfusion that influence oxygen delivery. The difference of the two readings will be the final measurement used for comparison.

Time frame: Measurements taken up to 6 weeks post sternotomy wound dressing

Secondary Outcomes

Wounds will be scored according to the ASEPSIS scoring system

This will be done by an observer who is blinded to the dressing used.

Time frame: On the day of dressing removal and at the 6 week postoperative outpatient visit.

Data from ClinicalTrials.gov

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