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

Study Overview
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Brief Summary
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Comparison of the Prevena™ IMS with the standard wound management method of sterile plaster in vascular surgery patients.

Detailed Description
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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.

Official Title
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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)

Conditions
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Infections

Intervention / Treatment
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* Device: Prevena™ IMS
* Other: sterile plaster dressings


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevena™ IMS<br>The patients in the experimental arm will be treated with the Prevena™ IMS seven days after the surgery | Device: Prevena™ IMS<br>* 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.<br>|
| Other: sterile plaster dressings<br>The wound will be treated with the conventional wound management method of sterile plaster dressing. | Other: sterile plaster dressings<br>* standard wound management method of sterile plaster dressings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound infections | The primary objective is the occurrence of inguinal wound infections following surgery. Wound infections will be classified according to Szilagyi. | 7 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular surgery patients, wound management