Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2015-01-31
2018-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High Risk - Prevena Care
The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
Prevena Care
The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
High Risk - Dry Gauze Dressing Care
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Low Risk - Dry Gauze Dressing Care
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Dry gauze dressing care
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Interventions
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Prevena Care
The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
Dry gauze dressing care
Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Unable to give informed consent
18 Years
ALL
No
Sponsors
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Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Paul DiMuzio, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Locations
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
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References
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Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10:CD015022. doi: 10.1002/14651858.CD015022.pub2.
Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.
Kwon J, Staley C, McCullough M, Goss S, Arosemena M, Abai B, Salvatore D, Reiter D, DiMuzio P. A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications. J Vasc Surg. 2018 Dec;68(6):1744-1752. doi: 10.1016/j.jvs.2018.05.224. Epub 2018 Aug 17.
Other Identifiers
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7179
Identifier Type: -
Identifier Source: org_study_id
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