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Vacuumtherapy After Venous Hybrid Procedures

Primary Purpose

Wound Infection

Status

Unknown status

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Prevena, KCI, Acelity, NPWT

About this trial

This is an interventional prevention trial for Wound Infection

Eligibility Criteria

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

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)

Sites / Locations

Maastricht University Medical CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Prevena

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02905955

First Posted

September 6, 2016

Last Updated

September 19, 2016

Sponsor

Maastricht University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02905955

Brief Title

Vacuumtherapy After Venous Hybrid Procedures

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maastricht University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wound Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prevena

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

Prevena, KCI, Acelity, NPWT

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Patients will be prospectively followed and checked for development of wound infections (grade 1-5). Therapy to treat the infections will be monitored.

Time Frame

3 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Timme van Vuuren, MD

timme.van.vuuren@mumc.nl

First Name & Middle Initial & Last Name or Official Title & Degree

J. van Laanen, MD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J. Laanen, MD

Organizational Affiliation

Maastricht University Medical Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maastricht University Medical Centre

City

Maastricht

State/Province

Limburg

ZIP/Postal Code

6229 HX

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Timme van Vuuren, MD

timme.van.vuuren@mumc.nl

First Name & Middle Initial & Last Name & Degree

J. van Laanen, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Vacuumtherapy After Venous Hybrid Procedures

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