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 Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Phasix™ Mesh |
Prophylactic onlay placement of mesh. |
|
|
No Intervention Primary Suture Closure |
Standard Fascial closure. |
|
Recruiting Locations
University of Kentucky Research Foundation
Lexington 4297983, Kentucky 6254925 40508
Lexington 4297983, Kentucky 6254925 40508
Dignity Health
Phoenix 5308655, Arizona 5551752 85013
Phoenix 5308655, Arizona 5551752 85013
University of California San Francisco
San Francisco 5391959, California 5332921 94143
San Francisco 5391959, California 5332921 94143
Tulane University School of Medicine
New Orleans 4335045, Louisiana 4331987 70112
New Orleans 4335045, Louisiana 4331987 70112
University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455
Minneapolis 5037649, Minnesota 5037779 55455
Rutgers Cancer Institute of New Jersey
New Brunswick 5101717, New Jersey 5101760 08901
New Brunswick 5101717, New Jersey 5101760 08901
New Hanover Regional Medical Center
Wilmington 4499379, North Carolina 4482348 28401
Wilmington 4499379, North Carolina 4482348 28401
The Ohio State University
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43210
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Vanderbilt University
Nashville 4644585, Tennessee 4662168 37232
Nashville 4644585, Tennessee 4662168 37232
More Details
- NCT ID
- NCT03911700
- Status
- Recruiting
- Sponsor
- C. R. Bard
Detailed Description
Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.