Phasix Mesh Use in Complex Open Ventral Hernias Study | NCT04580524

Studies
Phasix Mesh Use in Complex Open Ventral Hernias Study

NCT04580524

Sponsor

The University of Texas Health Science Center, Houston

Status

Withdrawn

Last Update Posted

Jun 22, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Ventral Hernia

Interventions

Repair of ventral hernia using biologic mesh
Repair of ventral hernia using suture repair or synthetic mesh

Countries

United States

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

Jun 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not able to secure funding

Expanded Access Info

Start Date

Apr 2021Estimated

Primary Completion Date

Apr 2021Estimated

Completion Date

Apr 2021Estimated

First Submitted Date

Oct 2, 2020

First Submission Date that Met QC Criteria

Oct 2, 2020

First Posted Date

Oct 8, 2020Actual

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

Jun 20, 2023

Last Update Posted Date

Jun 22, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Julie Holihan, Assistant Professor of Surgery-Clinical, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare clinical and patient centered outcomes of biosynthetic poly-4-hydroybutyrate meshes versus current care (synthetic polypropylene mesh or suture) for complex ventral hernia repair. The primary outcome for this study will be patients who are major complication free at 2 years postoperative. This will be a composite of hernia recurrence, reoperation, chronic wound complication, or death. Secondary outcomes include: surgical site occurences such as surgical site infection, seroma, hematoma and skin dehiscence within 90 days postoperative, emergency room visits withing 90 days postoperative, days in hospital up to 90 days postoperative, abdominal pain, and change in patient centered outcomes measured through the modified activities assessment scale (mAAS).

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phasix Mesh	Active Comparator	Phasix mesh will be used in the repair of the hernia	Procedure: Repair of ventral hernia using biologic mesh
Current Care	Active Comparator	The hernia will be repaired with either synthetic mesh or suture repair, as determined by the operating surgeon.	Procedure: Repair of ventral hernia using suture repair or synthetic mesh

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Repair of ventral hernia using biologic mesh	Procedure	Ventral hernia will be repaired using biologic mesh	Phasix Mesh

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major complication free	A composite of hernia recurrence, reoperation, chronic wound complication, or death	2 years post-operative

Secondary Outcomes

Measure	Description	Time Frame
Surgical site occurrences	Surgical site infection, seroma, hematoma, and skin dehiscence	90 days post-operative
Clavien-Dindo complication grade	Clavien-Dindo complication grade

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients (18 years or older) with a complex ventral hernia scheduled for repair

Exclusion Criteria:

Patients likely to die within 3 years (cirrhosis, terminal cancer, surgeon judgement)
Unlikely to follow-up (live out of state, unable to be reached by phone or email)
Non-English and non-Spanish speakers
Pregnant or breast-feeding patients
Allergies/hypersensitivities to tetracycline hydrochloride and kanamycin sulfate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julie Holihan, MD	UTHealth	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lyndon B. Johnson General Hospital		Houston	Texas	77026	United States
Memorial Hermann Hospital-Texas Medical Center

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006555	Hernia, Ventral

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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