Fracture Related InfectionNCT06193330
External Fixator or Antibiotic-coated Plate in Severe Open Long Bone Fractures
A study testing antibiotic-coated plate and external fixator in people with Fracture Related Infection, run by Oluwasegun Aremu at 2 sites in Nigeria.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture Related Infection
- What is being tested?
- antibiotic-coated plate and external fixator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 2 sitesNigeria
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria2 sites
Univeristy College Hospital, Ibadan, Nigeria
Ibadan, Oyo State, +234
Oluwasegun Aremu, +2347069414622, segunaremu2k3@yahoo.com
Olugboyega Oyewole, +2348023657211, dokitagboe@gmail.com
Federal Medical Centre, Owo
Owo, Ondo State, +234
About this study
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
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
- Conditions
- Fracture Related Infection
- Being tested
- antibiotic-coated plate, external fixator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic-coated plateProcedure or surgery
A plate for fixing long bone fractures is coated with antibiotics cement prepared in theatre
external fixatorProcedure or surgery
external fixators are applied to participants with severe long bone fractures
| Study group | Role | What they receive |
|---|---|---|
| antibiotic-coated plate | Experimental | participants will receive antibiotic-coated plate for treatment of their type III open long bone fractures Receives: Procedure: antibiotic-coated plate |
| External Fixator | Active comparator | participants will receive external fixator for treatment of their type III open long bone fractures Receives: Procedure: external fixator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (3)
number of participants who have fracture union after one year
participants will be assessed clinically and radiologically at 3months, 6months, and one year
Measured: one year
number of participants who require re-operation after 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
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion14 Feb 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Fracture Related InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oluwasegun Aremu
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Responsible party
- Sponsor-investigator, Oluwasegun Aremu, University College Hospital, Ibadan
- Investigators
- Oluwasegun Aremu, Principal investigator, University College Hospital, Ibadan, Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193330
- Sponsor's protocol ID
- interventional
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
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.
PubMed 29555119Blease R, Kanlic E. Management of open fractures. Bosn J Basic Med Sci. 2005 Nov;5(4):14-21. doi: 10.17305/bjbms.2005.3224.
PubMed 16351592Odatuwa-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.
PubMed 31692766Ikem IC, Oginni LM, Bamgboye EA. Open fractures of the lower limb in Nigeria. Int Orthop. 2001;25(6):386-8. doi: 10.1007/s002640100277.
PubMed 11820448Conway 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.
PubMed 25658083Ifesanya 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.
PubMed 23271839Ifesanya 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.
PubMed 24665159Metsemakers 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.
PubMed 28867644Aremu 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.
PubMed 38824836
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06193330
- Acronym / sponsor ID
- interventional
- Conditions
- Fracture Related Infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Oluwasegun AremuUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 14 Feb 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antibiotic-coated plate | Experimental | Procedure: antibiotic-coated plateparticipants will receive antibiotic-coated plate for treatment of their type III open long bone fractures |
| External Fixator | Active comparator | Procedure: external fixatorparticipants will receive external fixator for treatment of their type III open long bone fractures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Patients with traumatic brain injury,
- spinal cord injury,
- severe burns,
- refusal to consent,
- history of allergies to ceftriaxone or sulbactam,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antibiotic-coated plateA plate for fixing long bone fractures is coated with antibiotics cement prepared in theatre | Procedure or surgery | antibiotic-coated plate |
| external fixatorexternal fixators are applied to participants with severe long bone fractures | Procedure or surgery | External Fixator |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Background: PubMed 29555119Diwan 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.
- Background: PubMed 16351592Blease R, Kanlic E. Management of open fractures. Bosn J Basic Med Sci. 2005 Nov;5(4):14-21. doi: 10.17305/bjbms.2005.3224.
- Background: PubMed 31692766Odatuwa-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.
- Background: PubMed 11820448Ikem IC, Oginni LM, Bamgboye EA. Open fractures of the lower limb in Nigeria. Int Orthop. 2001;25(6):386-8. doi: 10.1007/s002640100277.
- Background: PubMed 25658083Conway 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.
- Background: PubMed 23271839Ifesanya 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.
- Background: PubMed 24665159Ifesanya 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.
- Background: PubMed 28867644Metsemakers 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.
- Derived from this study: PubMed 38824836Aremu 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oluwasegun Aremu principal investigator
University College Hospital, Ibadan, Nigeria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antibiotic-coated plate and external fixator in people with Fracture Related Infection, run by Oluwasegun Aremu at 2 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oluwasegun Aremu (+2347069414622, segunaremu2k3@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with fracture-related infection after 1 year (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06193330, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.