Status:
WITHDRAWN
DuraMesh Laparotomy Closure Following Trauma and Emergency Surgery
Lead Sponsor:
Uniformed Services University of the Health Sciences
Conditions:
Hernia Incisional
Suture, Complication
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The proposed project aims to evaluate the safety of DuraMesh™ suture for laparotomy closure in an emergent setting, while also providing preliminary efficacy data with regard to incisional hernia prev...
Detailed Description
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. Approximately 120 patients will be ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Midline laparotomy 5 cm (2 inches) long
- Urgent or emergent surgery following trauma
- Urgent or emergent surgery for diverticulitis
- Urgent or emergent surgery for large or small bowel obstruction
- Urgent or emergent surgery for exploratory laparotomy for acute abdomen
- Urgent or emergent surgery for exploratory laparotomy for intraabdominal hemorrhage
- Exclusion criteria
- Inability to provide informed consent
- Prior Hernia repair or existing ventral hernia mesh EXCLUDING inguinal hernias
- Metastatic cancer
- Pregnancy
- Immunosuppression
Exclusion
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04312165
Start Date
May 1 2023
End Date
May 1 2025
Last Update
May 10 2023
Active Locations (2)
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1
University of Maryland Shock Trauma
Baltimore, Maryland, United States, 21201
2
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889