Vacuumtherapy After Venous Hybrid Procedures

September 19, 2016 updated by: Maastricht University Medical Center

Negative Pressure Wound Management (NPWT) System for Inguinal Wounds After Venous Hybrid Procedures

All patients with deep venous obstruction below the sapheno-femoral junction elective for hybrid procedure with creation of an arterio venous-fistula (AVF) in the MUMC or patients with primary percutaneous procedure (and thus venous obstruction above the sapheno-femoral junction) who present with occluded stents which need an additional AVF after thrombolysis will receive a Prevena NPWT. Incidence of wound infections and wound scoring will be performed afterwards.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: J. van Laanen, MD

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Recruiting
        • Maastricht University Medical Centre
        • Contact:
        • Contact:
          • J. van Laanen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients with deep venous obstruction below the sapheno-femoral junction primary elective for hybrid procedure with creation of an AV-fistula in the MUMC
  • Be able to communicate in Dutch
  • Life expectancy >1 year

Exclusion Criteria:

  • Patients with allergies for the components of the used negative pressure incision management system (Prevena)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Prevena
Device: Prevena, KCI, Acelity, NPWT
All patients will receive a Prevena NPWT (if inclusion criteria are met)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With wound infections or Adverse Events That Are Related to Prevena incision management negative pressure wound therapy
Time Frame: 3 months
Patients will be prospectively followed and checked for development of wound infections (grade 1-5). Therapy to treat the infections will be monitored.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: J. Laanen, MD, Maastricht University Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 19, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL56603.068.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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