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.

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