lymph leakage wound infection
Conditions
Interventions
The Prevena system will be placed on the operation theatre like prescribed in
user manual.
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion 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. -All patients with occluded stents treated by thrombolysis and in need of an additional AV-fistula in the MUMC. -Patient must be able to fill in Dutch questionnaires and be able to communicate in Dutch -Life expectancy >1 year
Exclusion criteria
Exclusion criteria: -Patients with allergies for the components of the used negative pressure incision management system (Prevena) -Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, known to be non-compliant or presenting an unstable psychiatric history)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint Incidence of wound infections in patients treated with AV fistula and stenting and Prevena vacuum therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints (if applicable) Incidence of lymph leakage in patients treated with AV fistula and stenting and Prevena negative pressure management system Other study parameters (if applicable) Evaluate the clinical appearance and quality of the scar by filling out the Patient Observer Scar Assessment Scale v2.0 Nl and photos | — |
Countries
Netherlands
Outcome results
None listed