Cardiac EventPrevenaNCT02814084
Prevena Incision Management
A study testing Bilateral Internal Mammary Artery grafts and Prevena in people with Cardiac Event and Arrest; Cardiac, Complicating Surgery, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Event, Arrest; Cardiac, Complicating Surgery, Coronary Bypass Graft Stenosis
- What is being tested?
- Bilateral Internal Mammary Artery grafts and Prevena
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Sep 2016to 9 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS FT
Sheffield, England, S10 2JF
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Event, Arrest; Cardiac, Complicating Surgery, Coronary Bypass Graft Stenosis, Complication of Coronary Artery Bypass Graft
- Being tested
- Bilateral Internal Mammary Artery grafts, Prevena
- Medical subject headings
- Cardiovascular Diseases, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Internal Mammary Artery graftsDevice
Sternal Wound Edge Oxygenation in patients undergoing Coronary Artery bypass surgery with Bilateral Internal Mammary Artery grafts
PrevenaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Internal Mammary Artery grafts | Active comparator | Standard care wound dressings used as part of coronary artery bypass graft operation Receives: Device: Bilateral Internal Mammary Artery grafts |
| Prevena | Experimental | Prevena dressing used as part of coronary artery bypass graft operation. Receives: Device: Prevena |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurements taken up to 6 weeks post sternotomy wound dressing
Secondary outcomes (1)
Wounds will be scored according to the ASEPSIS scoring system
This will be done by an observer who is blinded to the dressing used.
Measured: On the day of dressing removal and at the 6 week postoperative outpatient visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start13 Sep 2016
- Primary completion9 Feb 2020
- Study completion9 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiac EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Norman Briffa, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814084
- Sponsor's protocol ID
- STH18497
- Acronym
- Prevena
- Status last verified
- May 2023
- First submitted
- 8 Jun 2016
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27175284Rowe 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.
PubMed 25332792Briffa N. Surgeons' attitudes to intraoperative death. Cardiac surgeons might have different attitudes. BMJ. 2001 Aug 11;323(7308):341-2. No abstract available.
PubMed 11548680Solodkyy 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.
PubMed 22543232Jenkins 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.
PubMed 35550716
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Prevena Incision Management System on Sternal Wound Edge Perfusion in Patients Undergoing CABG With Bilateral Mammary Artery Grafts
- ClinicalTrials.gov ID
- NCT02814084
- Acronym / sponsor ID
- Prevena / STH18497
- Conditions
- Cardiac Event, Arrest; Cardiac, Complicating Surgery, Coronary Bypass Graft Stenosis, Complication of Coronary Artery Bypass Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- 3M
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- 9 Feb 2020 (actual)
- Study completion
- 9 Feb 2020 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral Internal Mammary Artery grafts | Active comparator | Device: Bilateral Internal Mammary Artery graftsStandard care wound dressings used as part of coronary artery bypass graft operation |
| Prevena | Experimental | Device: PrevenaPrevena dressing used as part of coronary artery bypass graft operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Internal Mammary Artery graftsSternal Wound Edge Oxygenation in patients undergoing Coronary Artery bypass surgery with Bilateral Internal Mammary Artery grafts | Device | Bilateral Internal Mammary Artery grafts |
| PrevenaThe 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. | Device | Prevena |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Results publication: PubMed 27175284Holmes 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.
- Results publication: PubMed 25332792Rowe 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.
- Results publication: PubMed 11548680Briffa N. Surgeons' attitudes to intraoperative death. Cardiac surgeons might have different attitudes. BMJ. 2001 Aug 11;323(7308):341-2. No abstract available.
- Results publication: PubMed 22543232Solodkyy 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.
- Derived from this study: PubMed 35550716Jenkins 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman Briffa principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Internal Mammary Artery grafts and Prevena in people with Cardiac Event and Arrest; Cardiac, Complicating Surgery, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02814084, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023; AzTrials last refreshed its copy on 28 Oct 2026.