Prevena Incision Management

Not Applicable

Completed

• Conditions: Complication of Coronary Artery Bypass Graft; Cardiac Event; Coronary Bypass Graft Stenosis; Arrest; Cardiac, Complicating Surgery
• Interventions: Device: Prevena; Device: Bilateral Internal Mammary Artery grafts

• Registration Number: NCT02814084
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-27
• Study Start: 2016-09-13
• Primary Completion: 2020-02-09
• Study Completion: 2020-02-09
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prevena	Prevena	Prevena dressing used as part of coronary artery bypass graft operation.
Bilateral Internal Mammary Artery grafts	Bilateral Internal Mammary Artery grafts	Standard care wound dressings used as part of coronary artery bypass graft operation

Primary Outcome Measures

Name	Time	Method
NIRS measurement of the inferior third of the parasternal region and left forearm assessment	Measurements taken up to 6 weeks post sternotomy wound dressing	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.

Secondary Outcome Measures

Name	Time	Method
Wounds will be scored according to the ASEPSIS scoring system	On the day of dressing removal and at the 6 week postoperative outpatient visit.	This will be done by an observer who is blinded to the dressing used.

Trial Locations

Locations (1)

Sheffield Teaching Hospitals NHS FT; 🇬🇧 Sheffield, England, United Kingdom