Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

Purpose

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.

Condition

  • Open Midline Laparotomy

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phasix™ Mesh 		Prophylactic onlay placement of mesh.
  • Device: Phasix™ Mesh
    Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).
No Intervention
Primary Suture Closure 		Standard Fascial closure.

Recruiting Locations

Tulane University School of Medicine
New Orleans, Louisiana 70112
Contact:
Delainna Bartholomew
504-988-6902
dbartho@tulane.edu

More Details

Status
Recruiting
Sponsor
C. R. Bard

Study Contact

Amanda Resendes, MBA
401-209-7141
amanda.resendes@bd.com

Detailed Description

Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.