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

Infections Clinical Trial

— IMS  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395159
• Other study ID #: 14-048
• Status: Completed
• Phase: N/A
• First received: March 16, 2015
• Last updated: October 26, 2017
• Start date: July 2015
• Est. completion date: October 10, 2017

Study information

• Verified date: October 2017
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: October 10, 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infections
• Wound Infection

Intervention

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
standard wound management method of sterile plaster dressings

Locations

Country	Name	City	State
Germany	University Hospital Aachen, vascular surgery	Aachen
Germany	Marienhospital Wiiten, vascular surgery	Witten

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	length of hospital stay		up to 10 days
Secondary	antibiotic therapy		up to 30 days
Secondary	revision surgery		up to 30 days
Secondary	necessity of alternative wound dressings		up to 30 days
Secondary	prolongation of ambulant treatment		up to 30 days