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RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction

Sponsored by Jeffrey Janis

About this trial

Last updated 2 years ago

Study ID

2014H0041

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 99 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 11 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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).

No

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 difficult to consent those patients for the study preoperatively

- Patients with severe systemic sepsis

- Patients with frank purulence in the wound

Locations

Location

Status

Recruiting