Clinical trial NCT06193330: External Fixator or Antibiotic-coated Plate in Severe Open Long Bone Fractures
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fracture Related Infection
Lead sponsor: University College Hospital, Ibadan
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
First posted: 2024-01-05
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: number of participants with fracture-related infection after 1 year
timeFrame: one year
Secondary outcomes:
measure: number of participants who have fracture union after one year
timeFrame: one year
measure: number of participants who require re-operation after one year
timeFrame: one year
measure: change in 12-item Short Form Survey (SF-12) score at baseline and at one year follow-up
timeFrame: one year
Other outcomes:
measure: sub-group analysis of infection rate between smokers and non-smokers
timeFrame: one year
measure: sub-group analysis of infection rate between participants with and without co-morbidities
timeFrame: one year
Locations:
city: Owo
country: Nigeria
facility: Federal Medical Centre, Owo
state: Ondo State
city: Ibadan
country: Nigeria
facility: Univeristy College Hospital, Ibadan, Nigeria
state: Oyo
Study officials:
affiliation: University College Hospital, Ibadan, Nigeria
name: Oluwasegun Aremu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diwan A, Eberlin KR, Smith RM. The principles and practice of open fracture care, 2018. Chin J Traumatol. 2018 Aug;21(4):187-192. doi: 10.1016/j.cjtee.2018.01.002. Epub 2018 Feb 21.
citation: Blease R, Kanlic E. Management of open fractures. Bosn J Basic Med Sci. 2005 Nov;5(4):14-21. doi: 10.17305/bjbms.2005.3224.
citation: Odatuwa-Omagbemi DO. Open fractures: epidemiological pattern, initial management and challenges in a sub-urban teaching hospital in Nigeria. Pan Afr Med J. 2019 Jul 19;33:234. doi: 10.11604/pamj.2019.33.234.18141. eCollection 2019.
citation: Ikem IC, Oginni LM, Bamgboye EA. Open fractures of the lower limb in Nigeria. Int Orthop. 2001;25(6):386-8. doi: 10.1007/s002640100277.
citation: Conway JD, Hlad LM, Bark SE. Antibiotic cement-coated plates for management of infected fractures. Am J Orthop (Belle Mead NJ). 2015 Feb;44(2):E49-53.
citation: Ifesanya AO, Alonge TO. Operative stabilization of open long bone fractures: A tropical tertiary hospital experience. Niger Med J. 2012 Jan;53(1):16-20. doi: 10.4103/0300-1652.99825.
citation: Ifesanya AO, Ogundele OJ, Ifesanya JU. Orthopaedic surgical treatment delays at a tertiary hospital in sub Saharan Africa: Communication gaps and implications for clinical outcomes. Niger Med J. 2013 Nov;54(6):420-5. doi: 10.4103/0300-1652.126301.
citation: Metsemakers WJ, Morgenstern M, McNally MA, Moriarty TF, McFadyen I, Scarborough M, Athanasou NA, Ochsner PE, Kuehl R, Raschke M, Borens O, Xie Z, Velkes S, Hungerer S, Kates SL, Zalavras C, Giannoudis PV, Richards RG, Verhofstad MHJ. Fracture-related infection: A consensus on definition from an international expert group. Injury. 2018 Mar;49(3):505-510. doi: 10.1016/j.injury.2017.08.040. Epub 2017 Aug 24.