NCT02395159

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

March 16, 2015

Last Update Submit

October 26, 2017

Conditions

Infections

Keywords

vascular surgery patientswound management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

Prevena™ IMS

EXPERIMENTAL

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

Device: Prevena™ IMS

sterile plaster dressings

OTHER

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

Other: sterile plaster dressings

Interventions

Prevena™ IMSDEVICE

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.

Prevena™ IMS
sterile plaster dressingsOTHER

standard wound management method of sterile plaster dressings

sterile plaster dressings

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Aachen, vascular surgery

Aachen, 52074, Germany

Location

Marienhospital Wiiten, vascular surgery

Witten, 58452, Germany

Location

Related Publications (2)

  • Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.

    PMID: 41159585DERIVED

  • Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2.

    PMID: 40260835DERIVED

MeSH Terms

Conditions

Infections

Study Officials

  • Jochen Grommes

    University Hospital, Aachen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 20, 2015

Study Start

July 1, 2015

Primary Completion

July 1, 2017

Study Completion

October 10, 2017

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations

DE(2)