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Completed

NCT Number: NCT02814084

Prevena Incision Management

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheffield Teaching Hospitals NHS FT

Sheffield, England, S10 2JF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.)

Treatment and study plan

Bilateral Internal Mammary Artery grafts

Device

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

Prevena

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Wounds will be scored according to the ASEPSIS scoring system

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • 3M

Registry information

Official study title

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

Acronym: Prevena

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 27, 2016
Registry last updated
May 24, 2023

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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