Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
- Conditions
- Open Midline Laparotomy
- Interventions
- Device: Phasix™ Mesh
- Registration Number
- NCT03911700
- Lead Sponsor
- C. R. Bard
- Brief 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.
- Detailed Description
Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 477
- Must be ≥ 18 years of age
- Elective, open midline laparotomy ≥ 5 cm
- Willing and able to provide written informed consent
- Hernia risk equal to moderate or greater
- Previous hernia repair
- Emergent surgery
- Creation of skin flaps is preplanned
- Preplanned 2nd surgery
- Active skin pathology
- Life expectancy less than 36 months
- Pregnant or planning to become pregnant
- Receiving a medication/medical condition that may adversely affect wound healing
- ASA Class > IV
- Enrolled in another clinical trial
- Site personnel directly involved with this trial
- Any condition that would preclude the use of the device or the subject form completing the follow-up requirements
- Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
- Two separate incisions are created
- Prior onlay mesh
- Surgeon is unable to fully close the fascia
- The surgery requires more than a single piece of mesh
- Contraindication to placement of mesh
- CDC Class IV/Active Infection
- Breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phasix™ Mesh Phasix™ Mesh Prophylactic onlay placement of mesh.
- Primary Outcome Measures
Name Time Method Rate of Incisional Hernia 36-Months The primary endpoint of the trial is the occurrence of incisional hernia in each treatment group (Phasix™ Mesh or Control Group)
- Secondary Outcome Measures
Name Time Method Rate of Device-related Adverse Events (AEs) 60-Months Rate of Device-related Adverse Events (AEs)
Length of surgical procedure in minutes Study Day 0 Length of surgical procedure in minutes
Quality of Life: Optum Short Form Survey 12 Item Version 2 (SF-12v2®) 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.
Quality of Life: EuroQoL-5 Dimensions-3 Level (EQ-5D-3L©) 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".
Rate of Incisional Hernia 60-Months Rate of incisional hernia at each follow up time point
Length of time for wound closure in minutes Study Day 0 Length of time for wound closure in minutes
Length of hospital stay in days Through hospital stay, typically 3 days Length of hospital stay in days
Trial Locations
- Locations (41)
Centre Hospitalier Universitaire de Lille
🇫🇷Lille, France
Asklepios Klinik Barmbek
🇩🇪Hamburg, Germany
Dignity Health
🇺🇸Phoenix, Arizona, United States
Keck Medical Center of USC
🇺🇸Los Angeles, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
St. Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Emory University
🇺🇸Atlanta, Georgia, United States
OSF Saint Francis Medical Center
🇺🇸Peoria, Illinois, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Kentucky Research Foundation
🇺🇸Lexington, Kentucky, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Minneapolis VA Health Care System
🇺🇸Minneapolis, Minnesota, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Cox Health
🇺🇸Springfield, Missouri, United States
Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Nebraska Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
New York Presbyterian Hospital-Columbia University Medical Center
🇺🇸New York, New York, United States
Atrium Health
🇺🇸Charlotte, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Baptist Clinical Research Institute
🇺🇸Memphis, Tennessee, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
CAMC Health Education and Research Institute, Inc.
🇺🇸Charleston, West Virginia, United States
Krankenhaus der Barmherzigen Brüder Graz
🇦🇹Graz, Austria
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
CHU de Dijon Bourgogne
🇫🇷Dijon, France
Hôpital Paris St Joseph
🇫🇷Paris, France
Hôpital Lyon Sud
🇫🇷Pierre-Benite, France
CHU Reims
🇫🇷Reims, France
Hopitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology
🇩🇪Berlin, Germany
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Surgery
🇩🇪Berlin, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Bundeswehrzentralkrankenhaus Koblenz
🇩🇪Koblenz, Germany