External Fixator or Antibiotic-coated Plate in Severe Open Long Bone Fractures

Not Applicable

Not yet recruiting

• Conditions: Fracture Related Infection
• Interventions: Procedure: external fixator; Procedure: antibiotic-coated plate

• Registration Number: NCT06193330
• Lead Sponsor: Oluwasegun Aremu

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2023-12-21
• Last Update Submitted: 2023-12-21
• Study Start: 2024-01-01
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Primary Completion: 2026-02-14
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 178

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External Fixator	external fixator	participants will receive external fixator for treatment of their type III open long bone fractures
antibiotic-coated plate	antibiotic-coated plate	participants will receive antibiotic-coated plate for treatment of their type III open long bone fractures

Primary Outcome Measures

Name	Time	Method
number of participants with fracture-related infection after 1 year	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 Outcome Measures

Name	Time	Method
number of participants who require re-operation after one year	one year	during the course of follow-up, Patients with infection or other complications like malunion or non-union who require surgical intervention to achieve union will be noted and recorded
number of participants who have fracture union after one year	one year	participants will be assessed clinically and radiologically at 3months, 6months, and one year
change in 12-item Short Form Survey (SF-12) score at baseline and at one year follow-up	one year	SF-12 score of participants will be taking at baseline and also at one year of follow-up and these two scores will be assessed to determine any differences

Trial Locations

Locations (2)

Federal Medical Centre, Owo; 🇳🇬 Owo, Ondo State, Nigeria

Univeristy College Hospital, Ibadan, Nigeria; 🇳🇬 Ibadan, Oyo, Nigeria