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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedStudy Start
First participant enrolled
September 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2020
CompletedMay 24, 2023
May 1, 2023
3.4 years
June 8, 2016
May 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Wounds will be scored according to the ASEPSIS scoring system
On the day of dressing removal and at the 6 week postoperative outpatient visit.
Study Arms (2)
Bilateral Internal Mammary Artery grafts
ACTIVE COMPARATORStandard care wound dressings used as part of coronary artery bypass graft operation
Prevena
EXPERIMENTALPrevena dressing used as part of coronary artery bypass graft operation.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trustlead
- 3Mcollaborator
Study Sites (1)
Sheffield Teaching Hospitals NHS FT
Sheffield, England, S10 2JF, United Kingdom
Related Publications (5)
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.
PMID: 27175284RESULTRowe 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.
PMID: 25332792RESULTBriffa N. Surgeons' attitudes to intraoperative death. Cardiac surgeons might have different attitudes. BMJ. 2001 Aug 11;323(7308):341-2. No abstract available.
PMID: 11548680RESULTSolodkyy 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.
PMID: 22543232RESULTJenkins 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.
PMID: 35550716DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norman Briffa
Sheffield Teaching Hospitals NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2016
First Posted
June 27, 2016
Study Start
September 13, 2016
Primary Completion
February 9, 2020
Study Completion
February 9, 2020
Last Updated
May 24, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share