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Not yet recruiting NCT06193330

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

No phase Interventional Fracture Related Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: antibiotic-coated plate, external fixator.
Who it may be relevant to
Registry conditions: Fracture Related Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Nigeria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Procedure antibiotic-coated plate
    A plate for fixing long bone fractures is coated with antibiotics cement prepared in theatre
  • Procedure external fixator
    external fixators are applied to participants with severe long bone fractures

Primary outcome measures

  • number of participants with fracture-related infection after 1 year [Time frame: one year]
Secondary outcome measures (3)
  • number of participants who have fracture union after one year [Time frame: one year]
  • number of participants who require re-operation after one year [Time frame: one year]
  • change in 12-item Short Form Survey (SF-12) score at baseline and at one year follow-up [Time frame: one year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Nigeria · 2 centers
  • Federal Medical Centre, Owo — Owo
  • Univeristy College Hospital, Ibadan, Nigeria — Ibadan

Publications

  • 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. PMID 29555119
  • 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. PMID 16351592
  • 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. PMID 31692766
  • 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. PMID 11820448
  • 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. PMID 25658083
  • 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. PMID 23271839
  • 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. PMID 24665159
  • 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 PMID 28867644

Identifiers

NCT: NCT06193330 · interventional

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗