RECRUITING

Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-12-12
Study Completion:2031-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03911700

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Must be ≥ 18 years of age
  2. 2. Elective, open midline laparotomy ≥ 5 cm
  3. 3. Willing and able to provide written informed consent
  4. 4. Hernia risk equal to moderate or greater
  1. 1. Previous hernia repair
  2. 2. Emergent surgery
  3. 3. Creation of skin flaps is preplanned
  4. 4. Preplanned 2nd surgery
  5. 5. Active skin pathology
  6. 6. Life expectancy less than 36 months
  7. 7. Pregnant or planning to become pregnant
  8. 8. Receiving a medication/medical condition that may adversely affect wound healing
  9. 9. ASA Class \> IV
  10. 10. Enrolled in another clinical trial
  11. 11. Site personnel directly involved with this trial
  12. 12. Any condition that would preclude the use of the device or the subject form completing the follow-up requirements
  13. 13. Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
  14. 14. Two separate incisions are created
  15. 15. Prior onlay mesh
  16. 16. Surgeon is unable to fully close the fascia
  17. 17. The surgery requires more than a single piece of mesh
  18. 18. Contraindication to placement of mesh
  19. 19. CDC Class IV/Active Infection
  20. 20. Breastfeeding

Contacts and Locations

Study Contact

Amanda Resendes, MBA
CONTACT
401-209-7141
amanda.resendes@bd.com
Jaime Ritter, MPH
CONTACT
404-327-1221
jaime.ritter@bd.com

Principal Investigator

William Hope, MD
PRINCIPAL_INVESTIGATOR
New Hanover Regional Medical Center

Study Locations (Sites)

Dignity Health
Phoenix, Arizona, 85013
United States
Keck Medical Center of USC
Los Angeles, California, 90033
United States
University of California San Francisco
San Francisco, California, 94143
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
St. Francis Hospital and Medical Center
Hartford, Connecticut, 06105
United States
Emory University
Atlanta, Georgia, 30322
United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
United States
Indiana University
Indianapolis, Indiana, 46202
United States
University of Kentucky Research Foundation
Lexington, Kentucky, 40508
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417
United States
St. Luke's Hospital
Kansas City, Missouri, 64111
United States
Cox Health
Springfield, Missouri, 65807
United States
Nebraska Medical Center
Omaha, Nebraska, 68106
United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, 10032
United States
Atrium Health
Charlotte, North Carolina, 28203
United States
Duke University
Durham, North Carolina, 27708
United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
United States
The Ohio State University
Columbus, Ohio, 43210
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Baptist Clinical Research Institute
Memphis, Tennessee, 38163
United States
Vanderbilt University
Nashville, Tennessee, 37232
United States
CAMC Health Education and Research Institute, Inc.
Charleston, West Virginia, 25304
United States

Collaborators and Investigators

Sponsor: C. R. Bard

  • William Hope, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2019-12-12
Study Completion Date2031-12

Study Record Updates

Study Start Date2019-12-12
Study Completion Date2031-12

Terms related to this study

Additional Relevant MeSH Terms

  • Open Midline Laparotomy