Health TrialsbyHealthPanel

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

ConditionFracture Related Infection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOluwasegun Aremu

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients with traumatic brain injury,

spinal cord injury,

severe burns,

1 long bone fractures,

Trial design

Design model

Parallel

Treatments tested in this trial

  • antibiotic-coated plate

    Procedure/Surgery

    A plate for fixing long bone fractures is coated with antibiotics cement prepared in theatre

  • external fixator

    Procedure/Surgery

    external fixators are applied to participants with severe long bone fractures

Treatment groups

178 Participants
are divided into 2 treatment groups
Group A: antibiotic-coated plateExperimental treatment 1 intervention
Group B: External FixatorActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

number of participants with fracture-related infection after 1 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

Time frame
one year

Secondary outcomes

1

number of participants who have fracture union after one year

participants will be assessed clinically and radiologically at 3months, 6months, and one year

Time frame
one year
2

number of participants who require re-operation after 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

Time frame
one year
3

change in 12-item Short Form Survey (SF-12) score at baseline and at one year follow-up

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

Time frame
one year

Other outcomes

1

sub-group analysis of infection rate between smokers and non-smokers

The participants will be grouped into smokers and non-smokers and the infection rate between the two groups will be compared

Time frame
one year
2

sub-group analysis of infection rate between participants with and without co-morbidities

The participants will be grouped into those with co-morbidities and those without and the infection rate between the two groups will be compared

Time frame
one year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oluwasegun Aremu

Lead sponsor

University College Hospital, Ibadan

Sponsor institution

Orthopaedic Trauma Association

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: