Reduction of Groin Wound Infections After Vascular Surgery by Using an Incision Management System (IMS)
NCT02395159 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204
Last updated 2017-10-27
Summary
Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
RWTH Aachen University
lead OTHER
Principal Investigators
-
Jochen Grommes · University Hospital, Aachen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-07-31
- Primary Completion
- 2017-07-31
- Completion
- 2017-10-10
Countries
- Germany
Study Locations
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