NCT02395159

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-07-01
• Completion: 2017-10-10
• First posted: 2015-03-20
• Last updated: 2017-10-27

Locations

2 sites across 1 country: Germany