Endovascular ProceduresPREVENANCT03105154
Groin Wound Infection Rate Using Prevena Compared to Standard Dressing in Vascular Surgery Patients With High Risk
A study testing Prevena Dressing and Conventional Dressing in people with Endovascular Procedures, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Evaluate wound healing using Prevena compared to standard dressings in high risk patients after vascular surgery. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Endovascular Procedures
- What is being tested?
- Prevena Dressing and Conventional Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 10 Nov 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known bilateral vascular peripheral disease who are being evaluated for possible bilateral femoral endarterectomy
- Patients with one or more risk factor (diabetes mellitus, Obesity, heavy smoker, immunodeficiency disease, groin reoperation, prosthetic)
- Patients in follow-up at Clinic in the Vascular Surgery Department
- Sign of informed consent
- English speaking
Who cannot join
- Refusal to participate
- pregnancy
- unilateral femoral endarterectomy
- subjects for whom Prevena IMS is contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experience With the Negative Pressure Incision Management System (Prevena) in Vascular Surgery Patients With High Risk for Groin Wound Infection
Evaluate wound healing using Prevena compared to standard dressings in high risk patients after vascular surgery.
Read the detailed description
Patients submitted to bilateral femoral endarterectomy will have one groin dressed with PrevenaTM and the contralateral one dressed with conventional bandage immediately after suture. Both PrevenaTM and the conventional bandage at the contralateral side will be removed before the patient discharge. Groin wound complications such as deep space infection, cutaneous cellulitis, dehiscence or re-interventions for wound-related complications will be observed in a 30-day evaluation window. This observation will be performed during the patient admission and in the post-operative standard of care visits among the first 30 days.
- Conditions
- Endovascular Procedures
- Being tested
- Prevena Dressing, Conventional Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevena DressingOther
Prevena dressing is applied on one groin
Conventional DressingOther
Conventional dressing is applied on the contralateral groin
| Study group | Role | What they receive |
|---|---|---|
| Prevena Dressing | Experimental | Groin dressed with Prevena Receives: Other: Prevena Dressing |
| Conventional Dressing | Active comparator | Groin dressed with conventional bandage Receives: Other: Conventional Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of infection at 30 days
% of wound occurrence in the Prevena treated groin compared to conventional treated groin
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study startFeb 2016
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular ProceduresStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patient will be randomized sequentially to Prevena alternating with standard of care dressing
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Levester Kirksey, The Cleveland Clinic
- Investigators
- Leveser Kirksey, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105154
- Sponsor's protocol ID
- 15-1402
- Acronym
- PREVENA
- Status last verified
- Feb 2021
- First submitted
- 14 Mar 2017
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience With the Negative Pressure Incision Management System (Prevena) in Vascular Surgery Patients With High Risk for Groin Wound Infection
- ClinicalTrials.gov ID
- NCT03105154
- Acronym / sponsor ID
- PREVENA / 15-1402
- Conditions
- Endovascular Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 7 Apr 2017 (actual)
- 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.
Evaluate wound healing using Prevena compared to standard dressings in high risk patients after vascular surgery.
Detailed description
Patients submitted to bilateral femoral endarterectomy will have one groin dressed with PrevenaTM and the contralateral one dressed with conventional bandage immediately after suture. Both PrevenaTM and the conventional bandage at the contralateral side will be removed before the patient discharge. Groin wound complications such as deep space infection, cutaneous cellulitis, dehiscence or re-interventions for wound-related complications will be observed in a 30-day evaluation window. This observation will be performed during the patient admission and in the post-operative standard of care visits among the first 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patient will be randomized sequentially to Prevena alternating with standard of care dressing
| Arm | Type | Receives |
|---|---|---|
| Prevena Dressing | Experimental | Other: Prevena DressingGroin dressed with Prevena |
| Conventional Dressing | Active comparator | Other: Conventional DressingGroin dressed with conventional bandage |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with known bilateral vascular peripheral disease who are being evaluated for possible bilateral femoral endarterectomy
- Patients with one or more risk factor (diabetes mellitus, Obesity, heavy smoker, immunodeficiency disease, groin reoperation, prosthetic)
- Patients in follow-up at Clinic in the Vascular Surgery Department
- Sign of informed consent
- English speaking
Key exclusion criteria (4 listed)
- Refusal to participate
- pregnancy
- unilateral femoral endarterectomy
- subjects for whom Prevena IMS is contraindicated
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 |
|---|---|---|
| Prevena DressingPrevena dressing is applied on one groin | Other | Prevena Dressing |
| Conventional DressingConventional dressing is applied on the contralateral groin | Other | Conventional Dressing |
Primary outcome
% of infection at 30 days
Time frame: 30 days
% of wound occurrence in the Prevena treated groin compared to conventional treated groin
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 11 Feb 2021.
- 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.
Leveser Kirksey principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevena Dressing and Conventional Dressing in people with Endovascular Procedures, run by The Cleveland Clinic at 1 site in United States.
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 5 inclusion and 4 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 11 Feb 2021. 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 States. 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?
% of infection at 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2021; AzTrials last refreshed its copy on 31 Oct 2026.