antibiotic-coated plate
ProcedureA plate for fixing long bone fractures is coated with antibiotics cement prepared in theatre
Not Yet Recruiting
NCT Number: NCT06193330
External Fixator or Antibiotic-coated Plate in Severe Open Long Bone Fractures
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
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Federal Medical Centre, Owo, Owo, Ondo State, Nigeria
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
external fixator
Procedureexternal fixators are applied to participants with severe long bone fractures
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 have fracture union after one year
Time frame: 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
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
-
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
Other outcomes
-
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
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Olugboyega Oyewole
CONTACT
Oluwasegun Aremu
CONTACT
Sponsors and collaborators
Lead sponsor
Oluwasegun Aremu
Other
Collaborators
- Orthopaedic Trauma Association
Registry information
Official study title
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
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jan 5, 2024
- Registry last updated
- Jan 5, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Not Yet Recruiting
Hyperbaric Oxygen Therapy as Adjunctive Treatment for Fracture-Related Infection
NCT07535164
Fracture Related Infection, Hyperbaric Oxygenation
Amsterdam, North Holland, Netherlands
View Trial Details
Completed
Comparison of Debridement, Antibiotic, Implant Retention and Implant Exchange in Early-stage Fracture-related Infections
NCT07669714
Debridement, Fracture Related Infection
Antalya, Turkey (Türkiye)
View Trial Details
Recruiting
CERAMENT G Device Registry
NCT06010433
Chronic Osteomyelitis, Diabetic Foot Osteomyelitis
San Diego, California, United States
View Trial Details