Phasix Mesh Use in Complex Open Ventral Hernias Study

NCT ID: NCT04580524

Last Updated: 2023-06-22

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

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2021-04-30

Brief Summary

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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

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Conditions

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Ventral Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Phasix Mesh

Phasix mesh will be used in the repair of the hernia

Group Type ACTIVE_COMPARATOR

Repair of ventral hernia using biologic mesh

Intervention Type PROCEDURE

Ventral hernia will be repaired using biologic mesh

Current Care

The hernia will be repaired with either synthetic mesh or suture repair, as determined by the operating surgeon.

Group Type ACTIVE_COMPARATOR

Repair of ventral hernia using suture repair or synthetic mesh

Intervention Type PROCEDURE

Ventral hernia will be repaired using the current treatment methods

Interventions

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Repair of ventral hernia using biologic mesh

Ventral hernia will be repaired using biologic mesh

Intervention Type PROCEDURE

Repair of ventral hernia using suture repair or synthetic mesh

Ventral hernia will be repaired using the current treatment methods

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Julie Holihan

Assistant Professor of Surgery-Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie Holihan, MD

Role: PRINCIPAL_INVESTIGATOR

UTHealth

Locations

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Lyndon B. Johnson General Hospital

Houston, Texas, United States

Site Status

Memorial Hermann Hospital-Texas Medical Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-20-0655

Identifier Type: -

Identifier Source: org_study_id

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