Clinical trial NCT02084017: Negative Pressure Wound Therapy for the Prevention of Surgical Site Infection Following Lower Limb Revascularization
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Surgical Wound Infection
Peripheral Vascular Diseases
Keywords: Surgical Site Infection
Vascular Surgery
Negative Pressure Wound Therapy
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Kinetic Concepts, Inc.
First posted: 2014-03-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The study is a non-blinded randomized control trial. The study examines the effect on wound healing and surgical site infection using negative pressure wound therapy compared to standard dressing in high-risk patients (BMI \> 30, previous femoral cut-down). The investigators expected to find a lower surgical site infection rate in patients using the NPWT device.

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.

Eligibility criteria: Inclusion Criteria:

* BMI \> 35
* Previous femoral exposure
* Undergoing lower-limb revascularization

Exclusion Criteria:

* Cannot obtain seal
* Non-primary wound closure
* Pre-existing infection
* Endovascular repair

Primary outcomes:
measure: Surgical Site Infection
timeFrame: 30 days
Secondary outcomes:
measure: Length of stay
timeFrame: Date of discharge
measure: Emergency room visits
timeFrame: 30 days
measure: All-cause mortality
timeFrame: 30 days
measure: Re-operation rate
timeFrame: 30 days
measure: Amputation
timeFrame: 30 days
Other outcomes:
Locations:
city: London
country: Canada
facility: Victoria Hospital
state: Ontario
Study officials:
affiliation: London Health Sciences Center
name: Adam Power, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.