Sheffield Teaching Hospitals NHS FT
Sheffield, England, S10 2JF, United Kingdom
NCT Number: NCT02814084
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Sheffield, England, S10 2JF, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sternal Wound Edge Oxygenation in patients undergoing Coronary Artery bypass surgery with Bilateral Internal Mammary Artery grafts
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.
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.
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.
Sheffield Teaching Hospitals NHS Foundation Trust
Other
Effect of the Prevena Incision Management System on Sternal Wound Edge Perfusion in Patients Undergoing CABG With Bilateral Mammary Artery Grafts
Acronym: Prevena
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