Negative Pressure Wound Therapy for Surgical Site Infection Prevention in Common Femoral Artery Exposure

NCT03935659 | Withdrawn FDA Device

• 1 other identifier: 11956
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection; Groin Infections

Keywords

Negative Pressure Wound Therapy

Outcome Measures

Primary Outcomes (1)

• Superficial surgical site infection

  Surgical site infection as defined by the Center for disease control and prevention criteria

  30 days postoperatively

Secondary Outcomes (4)

• Mortality

  30 days

• Limb Loss

  30 days and 1 year

• Emergency department visit for wound complication

  within 30 days of surgery

• Local reaction to negative wound dressing

  5 days postoperatively

Study Arms (2)

Standard gauze therapy

ACTIVE COMPARATOR

The control group will receive a standard sterile gauge dressing over the groin incision. The dressing will be removed on post-operative day #2 and the wound will be inspected for any complications, followed by daily dressing changes and wound inspections until discharge.

Procedure: Standard Wound Care

Negative Pressure wound therapy

EXPERIMENTAL

The intervention group will receive a negative pressure dressing which will be applied in the operating room under sterile conditions. The brand of negative pressure dressing will be based on surgeon preference or center availability. The NPWT dressing will be removed on day 5 postoperatively or at discharge, whichever occurs first, and the groin wound inspected for any evidence of infection or dehiscence, and daily thereafter until discharge.

Device: Negative Pressure Pressure Wound Therapy

Interventions

Negative Pressure Pressure Wound Therapy DEVICE

Investigators will be using a Negative Pressure Wound Therapy Powered Suction Pump on primarily closed groin wounds after open common femoral artery exposure, The Negative pressure dressing will be applied in a sterile fashion in the operating room. The negative pressure dressing will be removed at day 5 postoperatively, or at discharge, whichever occurs first.

Negative Pressure wound therapy

Standard Wound Care PROCEDURE

Standard sterile gauze coverage of the primarily closed groin wound.

Standard gauze therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (19)

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  PMID: 41159585 DERIVED

Related Links

• CDC Criteria for Surgical Site Infection

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Loay Kabbani, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As this intervention necessitated the use of an external negative wound therapy device, masking is not possible
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Patient fulfilling the inclusion criteria will be randomized into a standard gauze therapy group or a negative pressure wound therapy group.

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 2, 2019
• Study Start: March 26, 2018
• Primary Completion: March 31, 2021
• Study Completion: October 1, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)