Actively Recruiting
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
Led by C. R. Bard · Updated on 2026-02-25
477
Participants Needed
44
Research Sites
624 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years of age or older
- Scheduled for elective, open midline laparotomy incision of 5 cm or larger
- Willing and able to provide written informed consent
- Have a hernia risk equal to moderate or greater
You will not qualify if you...
- Previous hernia repair
- Emergent surgery
- Planned creation of skin flaps
- Planned second surgery
- Active skin pathology
- Life expectancy less than 24 months
- Pregnant or planning to become pregnant
- Taking medications or having medical conditions that may impair wound healing
- American Society of Anesthesiologists (ASA) Class greater than IV
- Currently enrolled in another clinical trial
- Site personnel involved directly with this trial
- Any condition preventing use of the device or completion of follow-up
- Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
- Two separate incisions created during surgery
- Prior onlay mesh placement
- Surgeon unable to fully close the fascia
- Surgery requires more than one piece of mesh
- Contraindication to mesh placement
- Active infection classified as CDC Class IV
- Currently breastfeeding
AI-Screening
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Trial Site Locations
Total: 44 locations
1
Dignity Health
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Keck Medical Center of USC
Los Angeles, California, United States, 90033
Withdrawn
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
Hartford Hospital
Hartford, Connecticut, United States, 06102
Active, Not Recruiting
5
St. Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Withdrawn
6
Emory University
Atlanta, Georgia, United States, 30322
Terminated
7
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Active, Not Recruiting
8
Indiana University
Indianapolis, Indiana, United States, 46202
Active, Not Recruiting
9
University of Kentucky Research Foundation
Lexington, Kentucky, United States, 40508
Actively Recruiting
10
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Actively Recruiting
11
University of Michigan
Ann Arbor, Michigan, United States, 48109
Withdrawn
12
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States, 55417
Withdrawn
13
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
14
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
Withdrawn
15
Cox Health
Springfield, Missouri, United States, 65807
Withdrawn
16
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
17
Nebraska Medical Center
Omaha, Nebraska, United States, 68106
Withdrawn
18
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
Withdrawn
19
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
20
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, United States, 10032
Active, Not Recruiting
21
Montefiore Medical Center
The Bronx, New York, United States, 10467
Active, Not Recruiting
22
Atrium Health
Charlotte, North Carolina, United States, 28203
Active, Not Recruiting
23
Duke University
Durham, North Carolina, United States, 27708
Withdrawn
24
New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
Actively Recruiting
25
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
26
Oregon Health & Science University
Portland, Oregon, United States, 97239
Withdrawn
27
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
28
Baptist Clinical Research Institute
Memphis, Tennessee, United States, 38163
Active, Not Recruiting
29
Vanderbilt University
Nashville, Tennessee, United States, 37232
Actively Recruiting
30
CAMC Health Education and Research Institute, Inc.
Charleston, West Virginia, United States, 25304
Active, Not Recruiting
31
Krankenhaus der Barmherzigen Brüder Graz
Graz, Austria, 08020
Actively Recruiting
32
Universitair Ziekenhuis Gent
Ghent, Belgium, 09000
Actively Recruiting
33
CHU de Dijon Bourgogne
Dijon, France, 21079
Actively Recruiting
34
Centre Hospitalier Universitaire de Lille
Lille, France, 59000
Actively Recruiting
35
Centre Hospitalier Universitaire de Lille
Lille, France, 59000
Actively Recruiting
36
Hôpital Paris St Joseph
Paris, France, 75014
Actively Recruiting
37
Hôpital Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
38
CHU Reims
Reims, France, 51092
Actively Recruiting
39
Hopitaux Universitaires de Strasbourg
Strasbourg, France, 67000
Actively Recruiting
40
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology
Berlin, Germany, 13353
Withdrawn
41
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Surgery
Berlin, Germany, 13353
Withdrawn
42
Asklepios Klinik Barmbek
Hamburg, Germany, 22307
Actively Recruiting
43
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
44
Bundeswehrzentralkrankenhaus Koblenz
Koblenz, Germany, 56072
Actively Recruiting
Research Team
A
Amanda Resendes, MBA
CONTACT
J
Jaime Ritter, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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