NCT03935659

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

Negative Pressure Wound Therapy for Surgical Site Infection Prevention in Vascular Surgery Patients Undergoing Common Femoral Artery Exposure

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Infection
• Groin Infections

Interventions

Type	Name	Description
DEVICE	Negative Pressure Pressure Wound Therapy	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.
PROCEDURE	Standard Wound Care	Standard sterile gauze coverage of the primarily closed groin wound.

Timeline

• Start date: 2018-03-26
• Primary completion: 2021-03-31
• Completion: 2021-10-01
• First posted: 2019-05-02
• Last updated: 2021-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study