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Vacuumtherapy After Venous Hybrid Procedures

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02905955
Enrollment
40
Registered
2016-09-19
Start date
2016-09-30
Completion date
Unknown
Last updated
2016-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Infection

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.

Interventions

DEVICEPrevena, KCI, Acelity, NPWT

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

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients With wound infections or Adverse Events That Are Related to Prevena incision management negative pressure wound therapy3 monthsPatients will be prospectively followed and checked for development of wound infections (grade 1-5). Therapy to treat the infections will be monitored.

Countries

Netherlands

Contacts

Primary ContactTimme van Vuuren, MD
timme.van.vuuren@mumc.nl
Backup ContactJ. van Laanen, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026