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DuraMesh Laparotomy Study

Mesh Suture Inc. · 2023
ClinicalTrials.gov · Datasets · License: Public Domain · 2023
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complicationsmechanicalna
This is a multisite randomized control proof-of-concept trial to evaluate the safety of Duramesh laparotomy closure in the trauma and emergency laparotomy setting. The study will be performed at University of Maryland Shock Trauma Center and Walter Reed National Military Medical Center. One hundred (100) patients will be randomized (2:1) to Duramesh laparotomy closure versus conventional suture closure. After the patient has been confirmed to be a candidate for the trial, randomization will be performed in the operating room upon completion of the index abdominal procedure. Duramesh will be provided for patients assigned to the Duramesh treatment arm. Patients will be followed for 1 year following laparotomy closure at follow-up intervals of 1 month, 3 months, 6 months, and 12 months.
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