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

Reduction of Groin Wound Infections After Vascular Surgery in Patients With Risk Factors by the Use a Negative Pressure Wound Incision Management System (KCI Prevena)

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

Study Overview

• Status: Completed
• Conditions: Infections
• Intervention / Treatment: Device: Prevena™ IMS; Other: sterile plaster dressings

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 Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • University Hospital Aachen, vascular surgery
  • Witten, Germany, 58452
    • Marienhospital Wiiten, vascular surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prevena™ IMS; The patients in the experimental arm will be treated with the Prevena™ IMS seven days after the surgery	Device: Prevena™ IMS; Prevena™ IMS is intended for the management of the surgical incision environment and surrounding healthy skin in patients with a risk of postoperative complications such as infections. This entails the maintenance of a closed environment around the incision by applying a negative pressure wound therapy system. The corresponding dressing is known under the name Prevena™ Dressing. The layer closest to the skin comprises silver foil, which reduces the microbial colonisation of cells.
Other: sterile plaster dressings; The wound will be treated with the conventional wound management method of sterile plaster dressing.	Other: sterile plaster dressings; standard wound management method of sterile plaster dressings

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Jochen Grommes, University Hospital, Aachen

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): October 10, 2017

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: March 19, 2015
• First Posted (Estimate): March 20, 2015

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: wound management; vascular surgery patients
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Wound Infection
• Other Study ID Numbers: 14-048