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Completed

NCT Number: NCT02395159

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

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

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Key information

Conditions

Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Aachen, vascular surgery, Aachen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevena™ IMS

Device

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.

sterile plaster dressings

Other

standard wound management method of sterile plaster dressings

Primary outcomes

  1. 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

  1. length of hospital stay

    Time frame: up to 10 days

  2. antibiotic therapy

    Time frame: up to 30 days

  3. revision surgery

    Time frame: up to 30 days

  4. necessity of alternative wound dressings

    Time frame: up to 30 days

  5. prolongation of ambulant treatment

    Time frame: up to 30 days

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

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)

Acronym: IMS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 20, 2015
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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