Prophylactic Reinforcement of Ventral Abdominal Incisions Trial (PREVENT)

February 23, 2026 updated by: C. R. Bard

Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.

Study Type

Interventional

Enrollment (Estimated)

477

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Graz, Austria, 08020
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder Graz
        • Contact:
        • Principal Investigator:
          • Felix Aigner, Prof.
  • Belgium
      • Ghent, Belgium, 09000
        • Recruiting
        • Universitair Ziekenhuis Gent
        • Contact:
        • Principal Investigator:
          • Frederick Berrevoet, Prof.
  • France
      • Dijon, France, 21079
        • Recruiting
        • CHU de Dijon Bourgogne
        • Contact:
        • Principal Investigator:
          • Pablo Ortega-Deballon, Prof.
      • Lille, France, 59000
        • Recruiting
        • Centre Hospitalier Universitaire De Lille
        • Contact:
        • Principal Investigator:
          • Stephanie Truant, Prof.
      • Paris, France, 75014
        • Recruiting
        • Hôpital Paris St Joseph
        • Principal Investigator:
          • Yann Gouëffic, Prof.
        • Contact:
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Hôpital Lyon Sud
        • Contact:
        • Principal Investigator:
          • Guillaume Passot, Prof.
      • Reims, France, 51092
        • Recruiting
        • Chu Reims
        • Contact:
        • Principal Investigator:
          • Yohann Renard, Prof.
      • Strasbourg, France, 67000
        • Recruiting
        • Hopitaux universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Benoit Romain, Prof.
  • Germany
      • Berlin, Germany, 13353
        • Withdrawn
        • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Surgery
      • Berlin, Germany, 13353
        • Withdrawn
        • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology
      • Hamburg, Germany, 22307
        • Recruiting
        • Asklepios Klinik Barmbek
        • Contact:
        • Principal Investigator:
          • Maximilian Jusufi, MD
      • Heidelberg, Germany, 69120
        • Recruiting
        • UniversitatsKlinikum Heidelberg
        • Contact:
        • Principal Investigator:
          • Friedrich Kallinowski, Prof.
      • Koblenz, Germany, 56072
        • Recruiting
        • Bundeswehrzentralkrankenhaus Koblenz
        • Contact:
        • Principal Investigator:
          • Sebastian Schaaf, MD
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
    • California
      • Los Angeles, California, United States, 90033
        • Withdrawn
        • Keck Medical Center of USC
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco
        • Principal Investigator:
          • Hobart Harris, MD
        • Contact:
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Active, not recruiting
        • Hartford Hospital
      • Hartford, Connecticut, United States, 06105
        • Withdrawn
        • St. Francis Hospital and Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Terminated
        • Emory University
    • Illinois
      • Peoria, Illinois, United States, 61637
        • Active, not recruiting
        • OSF Saint Francis Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Active, not recruiting
        • Indiana University
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • Recruiting
        • University of Kentucky Research Foundation
        • Principal Investigator:
          • Scott J Roth, MD
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University School of Medicine
        • Principal Investigator:
          • Jennifer Silinsky, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Withdrawn
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Principal Investigator:
          • Wolfgang Gaertner, MD
        • Contact:
      • Minneapolis, Minnesota, United States, 55417
        • Withdrawn
        • Minneapolis VA Health Care System
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Withdrawn
        • St. Luke's Hospital
      • Springfield, Missouri, United States, 65807
        • Withdrawn
        • Cox Health
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Principal Investigator:
          • William Chapman, MD
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Withdrawn
        • Nebraska Methodist Hospital
      • Omaha, Nebraska, United States, 68106
        • Withdrawn
        • Nebraska Medical Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
        • Principal Investigator:
          • Henry Alexander, MD
    • New York
      • New York, New York, United States, 10032
        • Active, not recruiting
        • New York Presbyterian Hospital-Columbia University Medical Center
      • The Bronx, New York, United States, 10467
        • Active, not recruiting
        • Montefiore Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Active, not recruiting
        • Atrium Health
      • Durham, North Carolina, United States, 27708
        • Withdrawn
        • Duke University
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • New Hanover Regional Medical Center
        • Principal Investigator:
          • William Hope, MD
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
        • Principal Investigator:
          • Benjamin Poulose, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Withdrawn
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Active, not recruiting
        • Baptist Clinical Research Institute
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University
        • Contact:
        • Principal Investigator:
          • Richard Pierce, MD
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Active, not recruiting
        • CAMC Health Education and Research Institute, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Must be ≥ 18 years of age
  2. Elective, open midline laparotomy ≥ 5 cm
  3. Willing and able to provide written informed consent
  4. Hernia risk equal to moderate or greater

Exclusion Criteria:

  1. Previous hernia repair
  2. Emergent surgery
  3. Creation of skin flaps is preplanned
  4. Preplanned 2nd surgery
  5. Active skin pathology
  6. Life expectancy less than 24 months
  7. Pregnant or planning to become pregnant
  8. Receiving a medication/medical condition that may adversely affect wound healing
  9. ASA Class > IV
  10. Enrolled in another clinical trial
  11. Site personnel directly involved with this trial
  12. Any condition that would preclude the use of the device or the subject form completing the follow-up requirements
  13. Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
  14. Two separate incisions are created
  15. Prior onlay mesh
  16. Surgeon is unable to fully close the fascia
  17. The surgery requires more than a single piece of mesh
  18. Contraindication to placement of mesh
  19. CDC Class IV/Active Infection
  20. Breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phasix™ Mesh
Prophylactic onlay placement of mesh.
Device: Phasix™ Mesh
Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).
No Intervention: Primary Suture Closure
Standard Fascial closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Incisional Hernia
Time Frame: 24-Months
The primary endpoint of the trial is the occurrence of incisional hernia in each treatment group (Phasix™ Mesh or Control Group)
24-Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Incisional Hernia
Time Frame: 60-Months
Rate of incisional hernia at each follow up time point
60-Months
Rate of Device-related Adverse Events (AEs)
Time Frame: 60-Months
Rate of Device-related Adverse Events (AEs)
60-Months
Length of surgical procedure in minutes
Time Frame: Study Day 0
Length of surgical procedure in minutes
Study Day 0
Length of time for wound closure in minutes
Time Frame: Study Day 0
Length of time for wound closure in minutes
Study Day 0
Length of hospital stay in days
Time Frame: Through hospital stay, typically 3 days
Length of hospital stay in days
Through hospital stay, typically 3 days
Quality of Life: Optum Short Form Survey 12 Item Version 2 (SF-12v2®)
Time Frame: 60-Months
Health-related quality of life will be measured using the Optum SF-12v2. The questionnaire consists of 12 items weighted and summed to provide physical and mental health scores from the subject's perspective (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100, with higher score indicating better quality of life.
60-Months
Quality of Life: EuroQoL-5 Dimensions-3 Level (EQ-5D-3L©)
Time Frame: 60-months
EuroQoL-Five Dimensions questionnaire-using Three Levels EQ-5D-3L is a standardized instrument for measuring generic health status. It consists of two components; health status description and evaluation. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each dimension ranging from 1-3. From these five dimensions, EQ-5D index is calculated, having a value between 0-1. The evaluation part involves visual analogue scale, asking the subject to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. Zero corresponds to " the worst health you can imagine", and hundred corresponds to "the best health you can imagine".
60-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

C. R. Bard

Investigators

  • Principal Investigator: William Hope, MD, New Hanover Regional Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2019

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

April 4, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (Actual)

April 11, 2019

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • DVL-HE-018

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

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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