RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction (NCT02228889) | Clinical Trial Compass
CompletedNot Applicable
RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction
United States46 participantsStarted 2015-01
Plain-language 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 meshes are derived from pig skin from which cells have been removed and which have been sterilized. The two meshes are made by two different companies using different processes.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 …
What they're measuring
1
Rate of Surgical Site Occurrences (SSOs) at 6 Week