Status:
COMPLETED
RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction
Lead Sponsor:
Jeffrey Janis
Conditions:
Hernia, Ventral
Intestinal Fistula
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two me...
Detailed Description
This is a prospective, randomized-controlled trial comparing two porcine acellular matrices in abdominal wall reconstruction. It is single-blind (patients are blinded to the type of mesh used while su...
Eligibility Criteria
Inclusion
- Age \> 18
- Patients presenting for elective hernia repair, with Ventral Hernia Working Group (VHWG) grade 2 or above (Patients with a hernia who need hernia repair due to hernia size, discomfort, risk of bowel incarceration, effect on physical function), and who have comorbidities or contamination making the use of synthetic mesh contraindicated)
- Patients deemed to be good surgical candidates, with no active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease (patients who can have a major surgical procedure without an exceedingly high risk of medical complications such as pulmonary edema, myocardial infarction, pulmonary embolism, renal failure, life-threatening bleeding, stroke).
- Patients presenting for resection of large abdominal wall tumors who are expected to undergo have tumor extirpative defect that would require biologic mesh for closure (patients with a large tumor of the abdominal wall who will have a large defect in their fascia after resection, who need biologic mesh for reinforcement).
Exclusion
- Known allergy to porcine products
- Active smokers (within the past 4 weeks) presenting for elective hernia repair
- Patients with active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease presenting for elective hernia repair
- Patients presenting for emergent hernia repair (in the setting of bowel strangulation, necrosis, penetrating trauma) as it will be difficult to consent those patients for the study preoperatively
- Patients with severe systemic sepsis
- Patients with frank purulence in the wound
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02228889
Start Date
January 1 2015
End Date
March 27 2025
Last Update
June 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210