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

RWTH Aachen University

Status: Completed

Conditions: Infections

Treatments: Device: Prevena™ IMS; Other: sterile plaster dressings

Study type: Interventional

Funder types: Other

Identifiers

NCT02395159

14-048

Details and patient eligibility

About

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

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Prevena™ IMS

Experimental group

Description:

The patients in the experimental arm will be treated with the Prevena™ IMS seven days after the surgery

Treatment:

Device: Prevena™ IMS

sterile plaster dressings

Other group

Description:

The wound will be treated with the conventional wound management method of sterile plaster dressing.

Treatment:

Other: sterile plaster dressings