Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| 3M | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral Internal Mammary Artery grafts | Active Comparator | Standard care wound dressings used as part of coronary artery bypass graft operation |
|
| Prevena | Experimental | Prevena dressing used as part of coronary artery bypass graft operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Internal Mammary Artery grafts | Device | Sternal Wound Edge Oxygenation in patients undergoing Coronary Artery bypass surgery with Bilateral Internal Mammary Artery grafts |
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Norman Briffa | Sheffield Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield Teaching Hospitals NHS FT | Sheffield | England | S10 2JF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27175284 | Result | 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. | |
| 25332792 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 11548680 | Result | Briffa N. Surgeons' attitudes to intraoperative death. Cardiac surgeons might have different attitudes. BMJ. 2001 Aug 11;323(7308):341-2. No abstract available. |
| 22543232 | Result | 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. |
| 35550716 | Derived | Jenkins S, Komber M, Mattam K, Briffa N. Negative pressure wound therapy in patients with diabetes undergoing left internal thoracic artery harvest: A randomized control trial. J Thorac Cardiovasc Surg. 2024 Jan;167(1):256-268. doi: 10.1016/j.jtcvs.2022.01.060. Epub 2022 Apr 9. |