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NCT02905955 Clinical Trial

Vacuumtherapy After Venous Hybrid Procedures

Wound Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02905955
Other study ID # NL56603.068.16
Secondary ID
Status Recruiting
Phase Phase 4
First received September 6, 2016
Last updated September 19, 2016
Start date September 2016

Study information
Verified date September 2016
Source Maastricht University Medical Center
Contact Timme van Vuuren, MD
Email timme.van.vuuren@mumc.nl
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Prevena, KCI, Acelity, NPWT
All patients will receive a Prevena NPWT (if inclusion criteria are met)

Locations
Country Name City State
Netherlands Maastricht University Medical Centre Maastricht Limburg

Sponsors (1)
Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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