Phasix Mesh Use in Complex Open Ventral Hernias Study

The University of Texas Health Science Center, Houston

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Ventral Hernia

Interventions

Repair of ventral hernia using biologic meshPROCEDURE

Ventral hernia will be repaired using biologic mesh

Repair of ventral hernia using suture repair or synthetic meshPROCEDURE

Ventral hernia will be repaired using the current treatment methods

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Lyndon B. Johnson General Hospital

Houston, Texas, United States

Memorial Hermann Hospital-Texas Medical Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Major complication free

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

Time frame: 2 years post-operative

Secondary Outcomes

Surgical site occurrences

Surgical site infection, seroma, hematoma, and skin dehiscence

Time frame: 90 days post-operative

Clavien-Dindo complication grade

Time frame: 90 days post-operative

Hospital duration

Days in hospital composed of post-operative length of stay and readmissions

Time frame: 90 days post-operative

Emergency room visits

Number of times ER was visited

Time frame: 90 days post-operative

Cost Analysis

Analysis of costs as performed from the healthcare perspective

Time frame: 2 years

Post-operative abdominal pain

Measured by the visual analogue scale (VAS)

Time frame: 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)

Time frame: Day of consent and post-operatively at 1 month, 1 year and 2 years

Data from ClinicalTrials.gov

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