Fracture Related Infection
Conditions
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
Interventions
PROCEDUREantibiotic-coated plate
A plate for fixing long bone fractures is coated with antibiotics cement prepared in theatre
PROCEDUREexternal fixator
external fixators are applied to participants with severe long bone fractures
Sponsors
Orthopaedic Trauma Association
Oluwasegun Aremu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| sub-group analysis of infection rate between smokers and non-smokers | one year | The participants will be grouped into smokers and non-smokers and the infection rate between the two groups will be compared |
| sub-group analysis of infection rate between participants with and without co-morbidities | 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 |
Countries
Nigeria
Contacts
Primary ContactOluwasegun Aremu
Backup ContactOlugboyega Oyewole
Outcome results
None listed