Vacuumtherapy After Venous Hybrid Procedures

NCT ID: NCT02905955

Last Updated: 2016-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wound Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Prevena

Group Type OTHER

Prevena, KCI, Acelity, NPWT

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Prevena, KCI, Acelity, NPWT

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

J. Laanen, MD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Centre

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maastricht University Medical Centre

Maastricht, Limburg, Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Timme van Vuuren, MD

Role: CONTACT

J. van Laanen, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Timme van Vuuren, MD

Role: primary

J. van Laanen, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NL56603.068.16

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prevena Vascular Groin Wound Study
NCT02581904 UNKNOWN PHASE4