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| Name | Class |
|---|---|
| Orthopaedic Trauma Association | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| antibiotic-coated plate | Experimental | participants will receive antibiotic-coated plate for treatment of their type III open long bone fractures |
|
| External Fixator | Active Comparator | participants will receive external fixator for treatment of their type III open long bone fractures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antibiotic-coated plate | Procedure | A plate for fixing long bone fractures is coated with antibiotics cement prepared in theatre |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of participants with fracture-related infection after 1 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 | one year |
| Measure | Description | Time Frame |
|---|---|---|
| number of participants who have fracture union after one year | participants will be assessed clinically and radiologically at 3months, 6months, and one year | one year |
| number of participants who require re-operation after one year |
| Measure | Description | Time Frame |
|---|---|---|
| sub-group analysis of infection rate between smokers and non-smokers | The participants will be grouped into smokers and non-smokers and the infection rate between the two groups will be compared | one year |
| sub-group analysis of infection rate between participants with and without co-morbidities |
Inclusion Criteria:
Exclusion Criteria:
Patients with traumatic brain injury,
spinal cord injury,
severe burns,
refusal to consent,
history of allergies to ceftriaxone or sulbactam,
fractures associated with vascular injury
and non-compliance with follow-up.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oluwasegun Aremu | Contact | +2347069414622 | segunaremu2k3@yahoo.com | |
| Olugboyega Oyewole | Contact | +2348023657211 | dokitagboe@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Oluwasegun Aremu | University College Hospital, Ibadan, Nigeria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Medical Centre, Owo | Owo | Ondo State | +234 | Nigeria | ||
| Univeristy College Hospital, Ibadan, Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29555119 | Background | 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. | |
| 16351592 | Background | 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. |
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All IPD that underlie results in a publication
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| ID | Term |
|---|---|
| D016267 | External Fixators |
| ID | Term |
|---|---|
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| external fixator | Procedure | external fixators are applied to participants with severe long bone fractures |
|
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
| one year |
| change in 12-item Short Form Survey (SF-12) score at baseline and at one year follow-up | 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 | 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 |
| one year |
| Ibadan |
| Oyo State |
| +234 |
| Nigeria |
|
| 31692766 | Background | 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. |
| 11820448 | Background | 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. |
| 25658083 | Background | 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. |
| 23271839 | Background | 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. |
| 24665159 | Background | 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. |
| 28867644 | Background | 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. |
| 38824836 | Derived | 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. |
| D053831 | Surgical Fixation Devices |