Vacuumtherapy After Venous Hybrid Procedures | NCT02905955

Studies
Vacuumtherapy After Venous Hybrid Procedures

NCT02905955

Sponsor

Maastricht University Medical Center

Status

Unknown status

Last Update Posted

Sep 20, 2016Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Wound Infection

Interventions

Prevena, KCI, Acelity, NPWT

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Not provided

First Submitted Date

Sep 6, 2016

First Submission Date that Met QC Criteria

Sep 16, 2016

First Posted Date

Sep 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2016

Last Update Posted Date

Sep 20, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prevena	Other		Device: Prevena, KCI, Acelity, NPWT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prevena, KCI, Acelity, NPWT	Device	All patients will receive a Prevena NPWT (if inclusion criteria are met)	Prevena

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients With wound infections or Adverse Events That Are Related to Prevena incision management negative pressure wound therapy	Patients will be prospectively followed and checked for development of wound infections (grade 1-5). Therapy to treat the infections will be monitored.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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
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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Timme van Vuuren, MD	Contact			timme.van.vuuren@mumc.nl
J. van Laanen, MD	Contact

Overall Officials

Name	Affiliation	Role
J. Laanen, MD	Maastricht University Medical Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University Medical Centre	Recruiting	Maastricht	Limburg	6229 HX	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D014946	Wound Infection

ID	Term
D007239	Infections

Intervention Browse Module

MeSH Terms

ID	Term
D054843	Negative-Pressure Wound Therapy

Ancestor Terms

ID	Term
D004322	Drainage
D013812	Therapeutics
D013514	Surgical Procedures, Operative
D058106	Wound Closure Techniques

Browse Leaves

Not provided

Browse Branches

Not provided