Negative Pressure Wound Therapy for the Prevention of Surgical Site Infection Following Lower Limb Revascularization
NCT ID: NCT02084017
Last Updated: 2015-07-31
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
PHASE1/PHASE2
80 participants
INTERVENTIONAL
2014-07-31
2016-04-30
Brief Summary
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Negative pressure wound therapy consists of a closed, sealed system that produces negative pressure (vacuum) to the wound surface. The device itself consists of open-cell foam that is sealed with an occlusive adhesive dressing (covers and sticks to the incision) and suction is maintained by connecting suction tubes to a vacuum pump and waste collector.
The investigators objectives are to determine whether there will be any reduction in surgical site infection and this potential reduction will influence length of hospital stay, emergency room visits, antibiotic use and need for re-operation.
Detailed Description
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Patients after giving informed consent will be randomized to receive either NPWT or standard wound therapy following tier lower-limb revascularization operative. Both will be applied under sterile conditions immediately post-operatively. The intervention will be left for 4-7 days depending on the discharge date and the standard dressing will be removed on post-operative day two.
The data will be analyzed with an intention to treat analysis.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Current Standard
Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing applied under sterile conditions in the operating room following skin closure. Dressing changed post-operative day two and daily thereafter with daily inspection for infection by a physician.
Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing
Negative Pressure Wound Therapy
A negative pressure therapy (Kinetic Concepts, Inc, San Antionio, Tex) device will be applied under sterile conditions post-operatively and placed on suction (125-150 cm H2O). The device will be removed on post-operative day 4-7 depending on day of discharge.
Prevena (Negative Pressure Wound Therapy Device)
No other details required.
Interventions
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Prevena (Negative Pressure Wound Therapy Device)
No other details required.
Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previous femoral exposure
* Undergoing lower-limb revascularization
Exclusion Criteria
* Non-primary wound closure
* Pre-existing infection
* Endovascular repair
18 Years
ALL
No
Sponsors
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Kinetic Concepts, Inc.
INDUSTRY
Western University, Canada
OTHER
Responsible Party
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Dr. Adam Power
Principle Investigator
Principal Investigators
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Adam Power, MD
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Center
Locations
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Victoria Hospital
London, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Adam Power, MD
Role: primary
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.
Lee K, Murphy PB, Ingves MV, Duncan A, DeRose G, Dubois L, Forbes TL, Power A. Randomized clinical trial of negative pressure wound therapy for high-risk groin wounds in lower extremity revascularization. J Vasc Surg. 2017 Dec;66(6):1814-1819. doi: 10.1016/j.jvs.2017.06.084. Epub 2017 Aug 31.
Murphy P, Lee K, Dubois L, DeRose G, Forbes T, Power A. Negative pressure wound therapy for high-risk wounds in lower extremity revascularization: study protocol for a randomized controlled trial. Trials. 2015 Nov 4;16:504. doi: 10.1186/s13063-015-1026-1.
Other Identifiers
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RRG-104871
Identifier Type: -
Identifier Source: org_study_id