Vacuumtherapy After Venous Hybrid Procedures
Phase 4
- Conditions
- Wound Infection
- Interventions
- Device: Prevena, KCI, Acelity, NPWT
- Registration Number
- NCT02905955
- Lead Sponsor
- Maastricht University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prevena Prevena, KCI, Acelity, NPWT -
- Primary Outcome Measures
Name Time Method Number of Patients With wound infections or Adverse Events That Are Related to Prevena incision management negative pressure wound therapy 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Maastricht University Medical Centre
🇳🇱Maastricht, Limburg, Netherlands