Negative Pressure Wound Therapy for the Prevention of Surgical Site Infection Following Lower Limb Revascularization
Single Center Prospective Randomized Control Trial on Negative Pressure Wound Therapy for Primarily Closed Groin Incisions Following Lower-limb Re-vascularization to Reduce Surgical Site Infection
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study is to investigate the current standard of wound care following vascular operations compared to to a negative pressure wound therapy (vacuum dressing) and the rate of surgical site infections (SSIs) in patients undergoing surgery to restore blood flow to the lower limb(s). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2014
CompletedFirst Posted
Study publicly available on registry
March 11, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedJuly 31, 2015
July 1, 2015
1.3 years
March 5, 2014
July 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surgical Site Infection
Surgical site infection is defined by the CDC Guidelines for surgical site infection and by the Szilagyi classification of vascular wound infections.
30 days
Secondary Outcomes (5)
Length of stay
Date of discharge
Emergency room visits
30 days
All-cause mortality
30 days
Re-operation rate
30 days
Amputation
30 days
Study Arms (2)
Current Standard
ACTIVE COMPARATORStandard 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.
Negative Pressure Wound Therapy
EXPERIMENTALA 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.
Interventions
No other details required.
Eligibility Criteria
You may qualify if:
- BMI \> 35
- Previous femoral exposure
- Undergoing lower-limb revascularization
You may not qualify if:
- Cannot obtain seal
- Non-primary wound closure
- Pre-existing infection
- Endovascular repair
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Western University, Canadalead
- Kinetic Concepts, Inc.collaborator
Study Sites (1)
Victoria Hospital
London, Ontario, N6C 2R6, Canada
Related Publications (4)
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(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.
PMID: 41159585DERIVEDCristino 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.
PMID: 40260835DERIVEDLee 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.
PMID: 28865981DERIVEDMurphy 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.
PMID: 26537879DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Power, MD
London Health Sciences Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
March 5, 2014
First Posted
March 11, 2014
Study Start
July 1, 2014
Primary Completion
October 1, 2015
Study Completion
April 1, 2016
Last Updated
July 31, 2015
Record last verified: 2015-07