Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

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.

Conditions

Open Midline Laparotomy

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Study Overview

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Study Details

Study overview

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.

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

Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

Condition
Open Midline Laparotomy
Intervention / Treatment

-

Contacts and Locations

Phoenix

Dignity Health, Phoenix, Arizona, United States, 85013

Los Angeles

Keck Medical Center of USC, Los Angeles, California, United States, 90033

San Francisco

University of California San Francisco, San Francisco, California, United States, 94143

Hartford

Hartford Hospital, Hartford, Connecticut, United States, 06102

Hartford

St. Francis Hospital and Medical Center, Hartford, Connecticut, United States, 06105

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Peoria

OSF Saint Francis Medical Center, Peoria, Illinois, United States, 61637

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

Lexington

University of Kentucky Research Foundation, Lexington, Kentucky, United States, 40508

New Orleans

Tulane University School of Medicine, New Orleans, Louisiana, United States, 70112

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

C. R. Bard,

William Hope, MD, PRINCIPAL_INVESTIGATOR, New Hanover Regional Medical Center

Study Record Dates

2031-12