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

NCT06193330 | Not Yet Recruiting

• 1 other identifier: interventional
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 2

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

Conditions

Fracture Related Infection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• number of participants who have fracture union after one year

  one year

• number of participants who require re-operation after one year

  one year

• change in 12-item Short Form Survey (SF-12) score at baseline and at one year follow-up

  one year

Other Outcomes (2)

• sub-group analysis of infection rate between smokers and non-smokers

  one year

• sub-group analysis of infection rate between participants with and without co-morbidities

  one year

Study Arms (2)

antibiotic-coated plate

EXPERIMENTAL

participants will receive antibiotic-coated plate for treatment of their type III open long bone fractures

Procedure: antibiotic-coated plate

External Fixator

ACTIVE COMPARATOR

participants will receive external fixator for treatment of their type III open long bone fractures

Procedure: external fixator

Interventions

antibiotic-coated plate PROCEDURE

A plate for fixing long bone fractures is coated with antibiotics cement prepared in theatre

antibiotic-coated plate

external fixator PROCEDURE

external fixators are applied to participants with severe long bone fractures

External Fixator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with traumatic brain injury,
• spinal cord injury,
• severe burns,
• long bone fractures,
• refusal to consent,
• history of allergies to ceftriaxone or sulbactam,
• fractures associated with vascular injury
• and non-compliance with follow-up.

Sponsors & Collaborators

• Oluwasegun Aremu: lead
• Orthopaedic Trauma Association: collaborator

Study Sites (2)

Federal Medical Centre, Owo

Owo, Ondo State, +234, Nigeria

Location

Univeristy College Hospital, Ibadan, Nigeria

Ibadan, Oyo State, +234, Nigeria

Location

Related Publications (9)

• 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 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.

  PMID: 16351592 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.

  PMID: 31692766 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.

  PMID: 11820448 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.

  PMID: 25658083 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.

  PMID: 23271839 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.

  PMID: 24665159 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.

  PMID: 28867644 BACKGROUND

• 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.

  PMID: 38824836 DERIVED

MeSH Terms

Interventions

External Fixators

Intervention Hierarchy (Ancestors)

Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Oluwasegun Aremu

  University College Hospital, Ibadan, Nigeria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oluwasegun Aremu

CONTACT

+2347069414622; segunaremu2k3@yahoo.com

Olugboyega Oyewole

CONTACT

+2348023657211; dokitagboe@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: January 1, 2024
• Primary Completion: February 14, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

NG (2)