Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
204
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.
standard wound management method of sterile plaster dressings
University Hospital Aachen, vascular surgery
Aachen, Germany
Marienhospital Wiiten, vascular surgery
Witten, Germany
wound infections
The primary objective is the occurrence of inguinal wound infections following surgery. Wound infections will be classified according to Szilagyi.
Time frame: 7 days after the surgery
length of hospital stay
Time frame: up to 10 days
antibiotic therapy
Time frame: up to 30 days
revision surgery
Time frame: up to 30 days
necessity of alternative wound dressings
Time frame: up to 30 days
prolongation of ambulant treatment
Time frame: up to 30 days
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