NCT02905955

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

September 6, 2016

Last Update Submit

September 19, 2016

Conditions

Wound Infection

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With wound infections or Adverse Events That Are Related to Prevena incision management negative pressure wound therapy

    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

Study Arms (1)

Prevena

OTHER
Device: Prevena, KCI, Acelity, NPWT

Interventions

Prevena, KCI, Acelity, NPWTDEVICE

All patients will receive a Prevena NPWT (if inclusion criteria are met)

Prevena

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

MeSH Terms

Conditions

Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Study Officials

  • J. Laanen, MD

    Maastricht University Medical Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Timme van Vuuren, MD

CONTACT

timme.van.vuuren@mumc.nl

J. van Laanen, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 19, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2017

Last Updated

September 20, 2016

Record last verified: 2016-09

Locations

NL(1)