Clinical trial NCT03935659: Negative Pressure Wound Therapy for Surgical Site Infection Prevention in Common Femoral Artery Exposure
Official title: Negative Pressure Wound Therapy for Surgical Site Infection Prevention in Vascular Surgery Patients Undergoing Common Femoral Artery Exposure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Surgical Site Infection
Groin Infections
Keywords: Negative Pressure Wound Therapy
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient fulfilling the inclusion criteria will be randomized into a standard gauze therapy group or a negative pressure wound therapy group.
Primary purpose: PREVENTION

Brief summary: The purpose of this randomized clinical trial is to investigate the role of negative pressure wound therapy (NPWT) vs standard sterile gauze therapy on the incidence of surgical site infections (SSI) in primarily closed groin incisions in high risk patients undergoing any open common femoral artery exposure for a vascular surgery procedure.

Detailed description: Eligible patients are randomized pre-operatively into either a standard dressing or NPWT for the groin incision.

* 1 The control group receive a standard sterile gauge dressing over the groin incision. The dressing is removed on post-operative day #2 and the wound is inspected for a SSI or dehiscence, followed by daily dressing changes and wound inspections until discharge.
* 2 The intervention group will receive a NPWT dressing which will be applied in the operating room under sterile conditions. The NPWT dressing will be removed on Post operative day 5. The wound is inspected for a SSI or dehiscence, followed by daily dressing changes and wound inspections until discharge.

Eligibility criteria: Inclusion Criteria: One or more of the following

* Body Mass Index \>30 kg/m2
* Critical limb ischemia defined by Ankle Brachial Index\<0.35, rest pain, tissue loss and/or non-healing ulcers
* Procedure time \>240 min
* End Stage Renal Disease on dialysis
* Glycated hemoglobin ≥ 8.5%
* Transfusion ≥ 3 units packed Red Blood Cells
* Previous femoral artery cut-down

Exclusion Criteria:Any of the following

* Preexisting groin infection
* Complete vacuum seal cannot be achieved with negative pressure device
* Allergy to Adhesive Material
* Groin Surgery within last 30 days

Primary outcomes:
measure: Superficial surgical site infection
timeFrame: 30 days postoperatively
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Limb Loss
timeFrame: 30 days and 1 year
measure: Emergency department visit for wound complication
timeFrame: within 30 days of surgery
measure: Local reaction to negative wound dressing
timeFrame: 5 days postoperatively
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Loay Kabbani, MD
role: PRINCIPAL_INVESTIGATOR
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