Status:
NOT_YET_RECRUITING
External Fixator or Antibiotic-coated Plate in Severe Open Long Bone Fractures
Lead Sponsor:
Oluwasegun Aremu
Collaborating Sponsors:
Orthopaedic Trauma Association
Conditions:
Fracture Related Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to assess whether infection rate is reduced with use of antibiotic-coated plate in severe open tibial fractures compare to use of external fixators
Eligibility Criteria
Inclusion
- Age ≥ 18yrs,
- Gustilo-Anderson IIIA and IIIB open fractures,
- involvement of any long bone fractures that can be fixed with either plate or uniplanar external fixation,
- wound can be closed primarily, with skin graft or flap, or can heal secondarily
Exclusion
- Patients with traumatic brain injury,
- spinal cord injury,
- severe burns,
- 1 long bone fractures,
- refusal to consent,
- history of allergies to ceftriaxone or sulbactam,
- fractures associated with vascular injury
- and non-compliance with follow-up.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT06193330
Start Date
January 1 2024
End Date
December 31 2026
Last Update
January 5 2024
Active Locations (2)
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1
Federal Medical Centre, Owo
Owo, Ondo State, Nigeria, +234
2
Univeristy College Hospital, Ibadan, Nigeria
Ibadan, Oyo State, Nigeria, +234