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

Primary Purpose

Infections

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Prevena™ IMS
sterile plaster dressings
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections focused on measuring vascular surgery patients, wound management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Aachen, vascular surgery
  • Marienhospital Wiiten, vascular surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Prevena™ IMS

sterile plaster dressings

Arm Description

The patients in the experimental arm will be treated with the Prevena™ IMS seven days after the surgery

The wound will be treated with the conventional wound management method of sterile plaster dressing.

Outcomes

Primary Outcome Measures

wound infections
The primary objective is the occurrence of inguinal wound infections following surgery. Wound infections will be classified according to Szilagyi.

Secondary Outcome Measures

length of hospital stay
antibiotic therapy
revision surgery
necessity of alternative wound dressings
prolongation of ambulant treatment

Full Information

First Posted
March 16, 2015
Last Updated
October 26, 2017
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT02395159
Brief Title
Reduction of Groin Wound Infections After Vascular Surgery by Using an Incision Management System (IMS)
Acronym
IMS
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
October 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections
Keywords
vascular surgery patients, wound management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prevena™ IMS
Arm Type
Experimental
Arm Description
The patients in the experimental arm will be treated with the Prevena™ IMS seven days after the surgery
Arm Title
sterile plaster dressings
Arm Type
Other
Arm Description
The wound will be treated with the conventional wound management method of sterile plaster dressing.
Intervention Type
Device
Intervention Name(s)
Prevena™ IMS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
sterile plaster dressings
Intervention Description
standard wound management method of sterile plaster dressings
Primary Outcome Measure Information:
Title
wound infections
Description
The primary objective is the occurrence of inguinal wound infections following surgery. Wound infections will be classified according to Szilagyi.
Time Frame
7 days after the surgery
Secondary Outcome Measure Information:
Title
length of hospital stay
Time Frame
up to 10 days
Title
antibiotic therapy
Time Frame
up to 30 days
Title
revision surgery
Time Frame
up to 30 days
Title
necessity of alternative wound dressings
Time Frame
up to 30 days
Title
prolongation of ambulant treatment
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Grommes
Organizational Affiliation
University Hospital, Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Aachen, vascular surgery
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Marienhospital Wiiten, vascular surgery
City
Witten
ZIP/Postal Code
58452
Country
Germany

12. IPD Sharing Statement

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

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