Phasix Mesh Use in Complex Open Ventral Hernias Study

Withdrawn before enrolling · Not applicable

Conditions studied: Ventral Hernia

In brief

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).

Key facts

Study ID: NCT04580524
Run by: The University of Texas Health Science Center, Houston
People needed: 0
Starts: 2021-04-01
Expected to finish: 2021-04-01
Last updated by the study team: 2023-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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