Status:
NOT_YET_RECRUITING
Barbed Suture vs Non-Barbed Closure for Emergency Exploratory Laparotomy RCT
Lead Sponsor:
University of Southern California
Conditions:
Laparotomy
Dehiscence Wound
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
This randomized control trial aims to compare the efficacy of triclosan-coated barbed suture (TCB) versus conventional non-barbed polydioxanone (PDS) suture in the closure of the abdominal fascia afte...
Detailed Description
The proposed study is a randomized control trial that aims to compare the efficacy of triclosan-coated barbed suture versus conventional non-barbed polydioxanone (PDS) suture in the closure of the abd...
Eligibility Criteria
Inclusion
- All adult individuals aged 18 years or older who undergo emergent laparotomy via a midline approach for trauma or non-trauma emergency general surgery who undergo complete fascial closure at the time of the index laparotomy operation.
- Individuals with CDC Class I, II, III and IV type surgical wounds
Exclusion
- Individuals under 18 years of age
- Individuals with known immune deficiencies
- Individuals taking chronic immunosuppressive medications
- Individuals presenting with nosocomial infections
- Individuals presenting with pre-existing abdominal wall hernia
- Individuals requiring multiple operations for sequential fascial closure
- Individuals incarcerated at time of operation
- Individuals with known preexisting connective tissue disease
- Individuals with known preexisting ventral abdominal wall hernia
- Individuals who are pregnant time of operation
- Individuals who are deceased prior to conclusion of exploratory laparotomy
- Individuals lost to follow-up or deceased during the first 30 days after laparotomy.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06043414
Start Date
January 1 2024
End Date
January 31 2027
Last Update
November 28 2023
Active Locations (1)
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1
Los Angeles General Medical Center
Los Angeles, California, United States, 90033