External Fixator or Antibiotic-coated Plate in Severe Open Long Bone Fractures
NCT ID: NCT06193330
Last Updated: 2024-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
178 participants
INTERVENTIONAL
2024-01-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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antibiotic-coated plate
participants will receive antibiotic-coated plate for treatment of their type III open long bone fractures
antibiotic-coated plate
A plate for fixing long bone fractures is coated with antibiotics cement prepared in theatre
External Fixator
participants will receive external fixator for treatment of their type III open long bone fractures
external fixator
external fixators are applied to participants with severe long bone fractures
Interventions
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antibiotic-coated plate
A plate for fixing long bone fractures is coated with antibiotics cement prepared in theatre
external fixator
external fixators are applied to participants with severe long bone fractures
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Orthopaedic Trauma Association
OTHER
Oluwasegun Aremu
OTHER
Responsible Party
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Oluwasegun Aremu
DR
Principal Investigators
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Oluwasegun Aremu
Role: PRINCIPAL_INVESTIGATOR
University College Hospital, Ibadan, Nigeria
Locations
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Federal Medical Centre, Owo
Owo, Ondo State, Nigeria
Univeristy College Hospital, Ibadan, Nigeria
Ibadan, Oyo State, Nigeria
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Aremu O, Oyewole O, Ifesanya A, Olawoye O, Ogunlade O. Use of antibiotic-cement coated plate in the treatment of Gustilo-Anderson type III long bone fractures in low- and middle-income countries vs external fixation: A multicentre randomized control trial study protocol. Injury. 2024 Aug;55(8):111637. doi: 10.1016/j.injury.2024.111637. Epub 2024 May 28.
Other Identifiers
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interventional
Identifier Type: -
Identifier Source: org_study_id
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