Reduction of Groin Wound Infections After Vascular Surgery by Using an Incision Management System (IMS)

Not Applicable

Completed

• Conditions: Infections
• Interventions: Other: sterile plaster dressings; Device: Prevena™ IMS

• Registration Number: NCT02395159
• Lead Sponsor: RWTH Aachen University

Brief Summary

Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.

Detailed Description

Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.

The aim is to demonstrate that the application of the Prevena™ IMS significantly reduces the incidence of postoperative wound infections. The wound infections will be classified according to Szilagyi.

The treatment phase begins following vascular surgery with wound management using either the Prevena™ IMS or a standard wound dressing, depending on the group to which the patient was randomly assigned. It involves a minimum stay of 7 and maximum 10 days in hospital.

Study Timeline

• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-20
• Study Start: 2015-07
• Primary Completion: 2017-07
• Status Verified: 2017-10
• Study Completion: 2017-10-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• vascular surgery via right or left inguinal approach

• nicotine abuse (active or according to medical condition)

• risk factors:

  1. cardiac risk factors (arterial hypertension, coronary heart disease, status after myocardial infarction)
  2. metabolic disorders (diabetes mellitus type I type II, lipopathy or hyperhomocysteinemia) or chronic or acute renal insufficiency

• previous vascular surgery with inguinal approach

• signed informed consent form

• persons who are legally competent and mentally able to comprehend and follow the instructions of study personnel

Exclusion Criteria

• local skin infections (fungal infections, acne)
• pregnant and breast-feeding women
• simultaneous participation in another clinical trial
• persons who have been committed to an institution by court or administrative order
• persons in a dependency or employment relationship with the sponsor or investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sterile plaster dressings	sterile plaster dressings	The wound will be treated with the conventional wound management method of sterile plaster dressing.
Prevena™ IMS	Prevena™ IMS	The patients in the experimental arm will be treated with the Prevena™ IMS seven days after the surgery

Primary Outcome Measures

Name	Time	Method
wound infections	7 days after the surgery	The primary objective is the occurrence of inguinal wound infections following surgery. Wound infections will be classified according to Szilagyi.

Secondary Outcome Measures

Name	Time	Method
length of hospital stay	up to 10 days
antibiotic therapy	up to 30 days
revision surgery	up to 30 days
necessity of alternative wound dressings	up to 30 days
prolongation of ambulant treatment	up to 30 days

Trial Locations

Locations (2)

Marienhospital Wiiten, vascular surgery; 🇩🇪 Witten, Germany

University Hospital Aachen, vascular surgery; 🇩🇪 Aachen, Germany