A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients

Not Applicable

Terminated

• Conditions: Surgical Procedure, Unspecified
• Interventions: Device: Prevena Incision Management System

• Registration Number: NCT02399111
• Lead Sponsor: Northwell Health

Brief Summary

The purpose of this research study is to investigate if a new negative pressure incision (surgical cut) management system, could reduce the occurrence of groin wound infections after vascular surgery. This is a single use, sterile dressing that is applied to the patient's skin. It has an attached battery-powered unit that provides negative pressure (a vacuum environment) to the dressing and a disposable canister for the collection of wound fluids. The patient is being asked to participate in this study because the patient is planning to have a vascular surgery procedure that involves groin incision.

Detailed Description

Surgical site infection (SSI) in groin wounds after vascular surgery is a significant contributing factor for increased morbidity. Despite the use of prophylactic systemic antibiotics, postoperative groin wound infection still occurs in some circumstances and it continues to be a serious problem after vascular surgical procedures. The incidence of SSI varies from 5 - 40%, and depending upon the depth of infection and type of vascular procedure, the morbidity could range from prolonged hospital stay to limb loss.

Increased incidence of SSIs in patients is related to systemic factors like Diabetes, hypertension (HTN), history of smoking, chronic obstructive pulmonary disease (COPD), and local factors like disruption of lymphatics, groin proximity to the perineum, previous surgery at the same site and the use of prosthetic graft material.

Prophylactic systemic antibiotics have been routinely used in all vascular surgery procedures, and despite of gentle tissue handling, proper hemostasis and other technical points to minimize tissue trauma, SSIs do happen.

The investigators hypothesize that using a closed dressing system with negative pressure will keep the surgical site protected from nearby contaminated field and decrease the risk of infection

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-03-20
• Study First Posted: 2015-03-26
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-11
• Results First Submitted: 2016-11-16
• Results First Submitted QC: 2016-11-18
• Last Update Submitted: 2016-11-18
• Results First Posted: 2016-11-21
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Older than 18 years
2. Subjects are capable of giving informed written consent
3. Undergoing a vascular surgery procedure that involves a groin incision at North Shore University Hospital and Long Island Jewish Hospital.

Exclusion Criteria

1. The patient has a history of blood clotting disorders
2. Patient has evidence of infection in the groin area, where surgical procedure is planned
3. Patient body habitus precludes placement of Prevena dressing.
4. Allergy to Silver or acrylic adhesive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese:BMI≥30; Wound Vac	Prevena Incision Management System	Using Prevena Incision Management System
Not Obese:BMI<30; Wound Vac	Prevena Incision Management System	Using Prevena Incision Management System

Primary Outcome Measures

Name	Time	Method
Incidence of Wound Infection With Szilagyi Grade	30 days	This study was terminated prior to gathering of data.

Secondary Outcome Measures

Name	Time	Method
Assess the Safety of the Devise by Monitoring Incidence of Bleeding , Seroma Formation	30 days	This study was terminated prior to collection of data.

Trial Locations

Locations (1)

North Shore-LIJ Health System; 🇺🇸 Lake Success, New York, United States