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

December 21, 2023 updated by: Oluwasegun Aremu

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Nigeria
    • Ondo State
      • Owo, Ondo State, Nigeria, +234
        • Federal Medical Centre, Owo
    • Oyo
      • Ibadan, Oyo, Nigeria, +234
        • Univeristy College Hospital, Ibadan, Nigeria
        • Contact:
        • Contact:
        • Principal Investigator:
          • Oluwasegun Aremu
        • Sub-Investigator:
          • Olugboyega Oyewole
        • Sub-Investigator:
          • Olayinka Olawoye
        • Sub-Investigator:
          • Olusegun Ogunlage
        • Sub-Investigator:
          • Adeleke Ifesanya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: antibiotic-coated plate
participants will receive antibiotic-coated plate for treatment of their type III open long bone fractures
Procedure: antibiotic-coated plate
A plate for fixing long bone fractures is coated with antibiotics cement prepared in theatre
Active Comparator: External Fixator
participants will receive external fixator for treatment of their type III open long bone fractures
Procedure: external fixator
external fixators are applied to participants with severe long bone fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of participants who have fracture union after one year
Time Frame: one year
participants will be assessed clinically and radiologically at 3months, 6months, and one year
one year
number of participants who require re-operation after one year
Time Frame: 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
one year
change in 12-item Short Form Survey (SF-12) score at baseline and at one year follow-up
Time Frame: 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
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
sub-group analysis of infection rate between smokers and non-smokers
Time Frame: one year
The participants will be grouped into smokers and non-smokers and the infection rate between the two groups will be compared
one year
sub-group analysis of infection rate between participants with and without co-morbidities
Time Frame: one year
The participants will be grouped into those with co-morbidities and those without and the infection rate between the two groups will be compared
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oluwasegun Aremu

Collaborators

Orthopaedic Trauma Association

Investigators

  • Principal Investigator: Oluwasegun Aremu, University College Hospital, Ibadan, Nigeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

February 14, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

December 21, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Interventional (Oncolys BioPharma Inc)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD that underlie results in a publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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