NCT06193330
Not yet recruiting
Not Applicable
Use of Antibiotics-cement Coated Plate in the Treatment of Gustilo-Anderson Type III Long Bone Fractures in Low- and Middle-income Countries vs External Fixation: A Multi-centre Randomized Control Trial
Oluwasegun Aremu2 sites in 1 country178 target enrollmentStarted: January 1, 2024Last updated:
ConditionsFracture Related Infection
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Oluwasegun Aremu
- Enrollment
- 178
- Locations
- 2
- Primary Endpoint
- number of participants with fracture-related infection after 1 year
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
number of participants with fracture-related infection after 1 year
Time Frame: one year
participants will be followed-up for one year and occurrence of infection at any point during this time period will be noted and recorded once
Secondary Outcomes
- number of participants who require re-operation after one year(one year)
- number of participants who have fracture union after one year(one year)
- change in 12-item Short Form Survey (SF-12) score at baseline and at one year follow-up(one year)
Investigators
Oluwasegun Aremu
DR
University College Hospital, Ibadan
Study Sites (2)
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