Prevena Incision Management (Prevena)

Effect of the Prevena Incision Management System on Sternal Wound Edge Perfusion in Patients Undergoing CABG With Bilateral Mammary Artery Grafts

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Event; Complication of Coronary Artery Bypass Graft; Coronary Bypass Graft Stenosis; Arrest; Cardiac, Complicating Surgery
• Intervention / Treatment: Device: Bilateral Internal Mammary Artery grafts; Device: Prevena

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Sheffield, England, United Kingdom, S10 2JF
      • Sheffield Teaching Hospitals NHS FT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bilateral Internal Mammary Artery grafts; Standard care wound dressings used as part of coronary artery bypass graft operation	Device: Bilateral Internal Mammary Artery grafts; Sternal Wound Edge Oxygenation in patients undergoing Coronary Artery bypass surgery with Bilateral Internal Mammary Artery grafts
Experimental: Prevena; Prevena dressing used as part of coronary artery bypass graft operation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measurements taken up to 6 weeks post sternotomy wound dressing

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Collaborators: 3M
• Investigators: Principal Investigator: Norman Briffa, Sheffield Teaching Hospitals NHS Foundation Trust

Publications and helpful links

General Publications

• Holmes C, Briffa N. Patient-Reported Outcome Measures (PROMS) in patients undergoing heart valve surgery: why should we measure them and which instruments should we use? Open Heart. 2016 May 5;3(1):e000315. doi: 10.1136/openhrt-2015-000315. eCollection 2016.
• Rowe R, Iqbal J, Murali-Krishnan R, Sultan A, Orme R, Briffa N, Denvir M, Gunn J. Role of frailty assessment in patients undergoing cardiac interventions. Open Heart. 2014 Feb 1;1(1):e000033. doi: 10.1136/openhrt-2013-000033. eCollection 2014.
• Briffa N. Surgeons' attitudes to intraoperative death. Cardiac surgeons might have different attitudes. BMJ. 2001 Aug 11;323(7308):341-2. No abstract available.
• Solodkyy A, Shalhoub J, Chetty G, Briffa NP. A rare case of giant coronary artery aneurysm in the context of multiple arterial aneurysms. Int J Surg Case Rep. 2012;3(7):311-3. doi: 10.1016/j.ijscr.2012.03.023. Epub 2012 Mar 29.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2016
• Primary Completion (Actual): February 9, 2020
• Study Completion (Actual): February 9, 2020

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 27, 2016

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiovascular Diseases
• Other Study ID Numbers: STH18497

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No