Phasix Mesh Use in Complex Open Ventral Hernias Study

NCT04580524 | Withdrawn DMC

• 1 other identifier: HSC-MS-20-0655
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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).

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

• Major complication free

  A composite of hernia recurrence, reoperation, chronic wound complication, or death

  2 years post-operative

Secondary Outcomes (7)

• Surgical site occurrences

  90 days post-operative

• Clavien-Dindo complication grade

  90 days post-operative

• Hospital duration

  90 days post-operative

• Emergency room visits

  90 days post-operative

• Cost Analysis

  2 years

Study Arms (2)

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

Repair of ventral hernia using biologic mesh PROCEDURE

Ventral hernia will be repaired using biologic mesh

Phasix Mesh

Repair of ventral hernia using suture repair or synthetic mesh PROCEDURE

Ventral hernia will be repaired using the current treatment methods

Current Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (2)

Lyndon B. Johnson General Hospital

Houston, Texas, 77026, United States

Location

Memorial Hermann Hospital-Texas Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie Holihan, MD

  UTHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery-Clinical

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 8, 2020
• Study Start: April 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)