Phasix Mesh Use in Complex Open Ventral Hernias Study

Poly-4-hydroxybutyrate Mesh Versus Current Care of Complex Open Ventral Hernias: A Multi-Center Randomized Controlled Trial

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).

Study Overview

• Status: Withdrawn
• Conditions: Ventral Hernia
• Intervention / Treatment: Procedure: Repair of ventral hernia using biologic mesh; Procedure: Repair of ventral hernia using suture repair or synthetic mesh

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77026
      • Lyndon B. Johnson General Hospital
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital-Texas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phasix Mesh; Phasix mesh will be used in the repair of the hernia	Procedure: Repair of ventral hernia using biologic mesh; Ventral hernia will be repaired using biologic mesh
Active Comparator: Current Care; 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; Ventral hernia will be repaired using the current treatment methods

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	90 days post-operative
Hospital duration	Days in hospital composed of post-operative length of stay and readmissions	90 days post-operative
Emergency room visits	Number of times ER was visited	90 days post-operative
Cost Analysis	Analysis of costs as performed from the healthcare perspective	2 years
Post-operative abdominal pain	Measured by the visual analogue scale (VAS)	Day of consent and post-operatively at 1 month, 1 year and 2 years
Patient centered outcomes	Abdominal wall health status (AW-HS) measured through the modified activities assessment scale (mAAS)	Day of consent and post-operatively at 1 month, 1 year and 2 years

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Julie Holihan, MD, UTHealth

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2021
• Primary Completion (Estimated): April 1, 2021
• Study Completion (Estimated): April 1, 2021

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: HSC-MS-20-0655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No