Prophylactic Reinforcement of Ventral Abdominal Incisions Trial (PREVENT)

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: Active, not recruiting
• Conditions: Open Midline Laparotomy
• Intervention / Treatment: Device: Phasix™ Mesh

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 (Actual): 477
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 08020
    • Krankenhaus der Barmherzigen Brüder Graz
• Belgium
  • Ghent, Belgium, 09000
    • Universitair Ziekenhuis Gent
• France
  • Dijon, France, 21079
    • CHU de Dijon Bourgogne
  • Paris, France, 75014
    • Hôpital Paris St Joseph
  • Pierre-Bénite, France, 69495
    • Hopital Lyon Sud
  • Reims, France, 51092
    • Chu Reims
  • Strasbourg, France, 67000
    • Hopitaux Universitaires de Strasbourg
  • France
    • Lille, France, France, 59000
      • Centre Hospitalier Universitaire de Lille
• Germany
  • Berlin, Germany, 13353
    • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology
  • Heidelberg, Germany, 69120
    • Universitatsklinikum Heidelberg
  • Koblenz, Germany, 56072
    • Bundeswehrzentralkrankenhaus Koblenz
  • Germany
    • Hamburg, Germany, Germany, 22307
      • Asklepios Klinik Barmbek
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Dignity Health
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Peoria, Illinois, United States, 61637
      • OSF Saint Francis Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Kentucky
    • Lexington, Kentucky, United States, 40508
      • University of Kentucky Research Foundation
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Cancer Institute of New Jersey
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital-Columbia University Medical Center
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health
    • Wilmington, North Carolina, United States, 28401
      • New Hanover Regional Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • Baptist Clinical Research Institute
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • CAMC Health Education and Research Institute, Inc.

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	Rate of incisional hernia at each follow up time point	60-Months
Rate of Device-related Adverse Events (AEs)	Rate of Device-related Adverse Events (AEs)	60-Months
Length of surgical procedure in minutes	Length of surgical procedure in minutes	Study Day 0
Length of time for wound closure in minutes	Length of time for wound closure in minutes	Study Day 0
Length of hospital stay in 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®)	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©)	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

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: William Hope, MD, New Hanover Regional Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2019
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 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): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 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