Clinical trial NCT03911700: Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
Official title: Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Open Midline Laparotomy
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2019-04-11
Enrollment: 477
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 36 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

Primary outcomes:
measure: Rate of Incisional Hernia
timeFrame: 36-Months
Secondary outcomes:
measure: Rate of Incisional Hernia
timeFrame: 60-Months
measure: Rate of Device-related Adverse Events (AEs)
timeFrame: 60-Months
measure: Length of surgical procedure in minutes
timeFrame: Study Day 0
measure: Length of time for wound closure in minutes
timeFrame: Study Day 0
measure: Length of hospital stay in days
timeFrame: Through hospital stay, typically 3 days
measure: Quality of Life: Optum Short Form Survey 12 Item Version 2 (SF-12v2®)
timeFrame: 60-Months
measure: Quality of Life: EuroQoL-5 Dimensions-3 Level (EQ-5D-3L©)
timeFrame: 60-months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Dignity Health
state: Arizona
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Hartford
country: United States
facility: St. Francis Hospital and Medical Center
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Research Foundation
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Springfield
country: United States
facility: Cox Health
state: Missouri
city: Omaha
country: United States
facility: Nebraska Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital-Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: Baptist Clinical Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Charleston
country: United States
facility: CAMC Health Education and Research Institute, Inc.
state: West Virginia
city: Graz
country: Austria
facility: Krankenhaus der Barmherzigen Brüder Graz
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Dijon
country: France
facility: CHU de Dijon Bourgogne
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Paris
country: France
facility: Hôpital Paris St Joseph
city: Pierre-Benite
country: France
facility: Hôpital Lyon Sud
city: Reims
country: France
facility: CHU Reims
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Surgery
city: Hamburg
country: Germany
facility: Asklepios Klinik Barmbek
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Koblenz
country: Germany
facility: Bundeswehrzentralkrankenhaus Koblenz
Study officials:
affiliation: New Hanover Regional Medical Center
name: William Hope, MD
role: PRINCIPAL_INVESTIGATOR
References: