Vacuumtherapy After Venous Hybrid Procedures

Maastricht University Medical Centre (MUMC)

Status and phase: Unknown; Phase 4

Conditions: Wound Infection

Treatments: Device: Prevena, KCI, Acelity, NPWT

Study type: Interventional

Funder types: Other

Identifiers

NCT02905955

NL56603.068.16

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Prevena

Other group

Treatment:

Device: Prevena, KCI, Acelity, NPWT