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DuraMesh Laparotomy Study

NCT03966768 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-09-13

No results posted yet for this study

Summary

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.

Conditions

  • Laparotomy
  • Suture; Complications, Mechanical
  • Hernia Incisional

Interventions

DEVICE

Duramesh suturable mesh for laparotomy closure

Patients undergoing laparotomy will be closed with Duramesh suturable mesh

DEVICE

Conventional suture for laparotomy closure

Patients undergoing laparotomy will be closed with conventional polydiaxonone suture

Sponsors & Collaborators

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • Walter Reed National Military Medical Center

    collaborator FED

  • University of Maryland

    collaborator OTHER

  • Mesh Suture Inc.

    lead INDUSTRY

Principal Investigators

  • Jason M Souza, MD · Walter Reed Army Institute of Research (WRAIR)

  • Thomas Scalea, MD · U Maryland Shock Trauma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-15
Primary Completion
2024-12-31
Completion
2025-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03966768 on ClinicalTrials.gov