Infections
Conditions
Keywords
vascular surgery patients, wound management
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.
Interventions
DEVICEPrevena™ 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.
OTHERsterile plaster dressings
standard wound management method of sterile plaster dressings
Sponsors
RWTH Aachen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| wound infections | 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
| Measure | Time frame |
|---|---|
| length of hospital stay | up to 10 days |
| antibiotic therapy | up to 30 days |
| revision surgery | up to 30 days |
| necessity of alternative wound dressings | up to 30 days |
| prolongation of ambulant treatment | up to 30 days |
Countries
Germany
Outcome results
None listed