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

Oluwasegun Aremu

Status: Not yet enrolling

Conditions: Fracture Related Infection

Treatments: Procedure: external fixator; Procedure: antibiotic-coated plate

Study type: Interventional

Funder types: Other

Identifiers

NCT06193330

interventional

Details and patient eligibility

About

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

Enrollment: 178 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

antibiotic-coated plate

Experimental group

Description:

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

Treatment:

Procedure: antibiotic-coated plate

External Fixator

Active Comparator group

Description:

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

Treatment:

Procedure: external fixator