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

Not Applicable

Withdrawn

• Conditions: Groin Infections; Surgical Site Infection

• Registration Number: NCT03935659
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study Start: 2018-03-26
• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-10
• Primary Completion: 2021-03-31
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Superficial surgical site infection	30 days postoperatively	Surgical site infection as defined by the Center for disease control and prevention criteria

Secondary Outcome Measures

Name	Time	Method
Mortality	30 days	Occurrence of mortality within 30 days of surgery
Local reaction to negative wound dressing	5 days postoperatively	Occurrence of a local reaction at the site of the negative pressure apparatus during application
Limb Loss	30 days and 1 year	Occurrence of ipsilateral limb loss SSI within 30 days and 1 year of surgery
Emergency department visit for wound complication	within 30 days of surgery	Number of participants returning to the emergency department for wound complications within 30 days of surgery

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States