egative pressure wound management system for inguinal wounds after venous hybrid procedures

Completed

• Conditions: lymph leakage; wound infection; 10004018; 10003184

• Registration Number: NL-OMON43445
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• 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.
-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

-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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint<br /><br>Incidence of wound infections in patients treated with AV fistula and stenting<br /><br>and Prevena vacuum therapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints (if applicable)<br /><br>Incidence of lymph leakage in patients treated with AV fistula and stenting and<br /><br>Prevena negative pressure management system<br /><br>Other study parameters (if applicable)<br /><br>Evaluate the clinical appearance and quality of the scar by filling out the<br /><br>Patient Observer Scar Assessment Scale v2.0 Nl and photos</p><br>