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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- RWTH Aachen University
- Enrollment
- 204
- Locations
- 2
- Primary Endpoint
- wound infections
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •vascular surgery via right or left inguinal approach
- •nicotine abuse (active or according to medical condition)
- •risk factors:
- •cardiac risk factors (arterial hypertension, coronary heart disease, status after myocardial infarction)
- •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
Arms & Interventions
Prevena™ IMS
The patients in the experimental arm will be treated with the Prevena™ IMS seven days after the surgery
Intervention: Prevena™ IMS (Device)
sterile plaster dressings
The wound will be treated with the conventional wound management method of sterile plaster dressing.
Intervention: sterile plaster dressings (Other)
Outcomes
Primary Outcomes
wound infections
Time Frame: 7 days after the surgery
The primary objective is the occurrence of inguinal wound infections following surgery. Wound infections will be classified according to Szilagyi.
Secondary Outcomes
- revision surgery(up to 30 days)
- necessity of alternative wound dressings(up to 30 days)
- prolongation of ambulant treatment(up to 30 days)
- length of hospital stay(up to 10 days)
- antibiotic therapy(up to 30 days)