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Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

NCT03911700 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 477

Last updated 2026-02-25

No results posted yet for this study

Summary

This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery.

Conditions

  • Open Midline Laparotomy

Interventions

DEVICE

Phasix™ Mesh

Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • William Hope, MD · New Hanover Regional Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-12
Primary Completion
2029-12-31
Completion
2031-12-31
FDA Device
Yes

Countries

  • United States
  • Austria
  • Belgium
  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03911700 on ClinicalTrials.gov