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Comparison of Debridement, Antibiotic, Implant Retention and Implant Exchange in Early-stage Fracture-related Infections

Comparison of Debridement, Antibiotic, Implant Retention and Implant Exchange in Early-stage Fracture-related Infections

Recruiting
18 years and older
All
Phase N/A

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Overview

This study aims to compare the clinical outcomes of debridement, antibiotics, and implant retention (DAIR) and implant removal/replacement methods used in the treatment of fracture-related infections, and to determine the infection-free fracture healing rates and the factors affecting treatment success.

Description

Fracture-related infection remains one of the most challenging musculoskeletal complications in orthopedic trauma surgery. Its diagnosis is a multi-stage process based on various diagnostic criteria. The international consensus definition of fracture-related infection was standardized in 2018, and this definition has been reinforced with updates in subsequent years. The recently validated consensus definition of fracture-related infection offers clinicians the opportunity to standardize clinical reports and improve the quality of published literature. The consensus definition definitively indicates the presence of infection \[confirmatory criteria; (1) fistula/sinus tract/incision site dehiscence, (2) purulent drainage during surgery, (3) growth of the same pathogen in ≥2 separate deep tissue/implant cultures\] or possibly indicates the presence of infection \[suggestive criteria; The diagnostic criteria are based on (1) local pain, redness, increased heat, (2) wound exudation, (3) fever, (4) elevated CRP and ESR, (5) implant loosening, osteolysis, non-union. The presence of suggestive criteria should raise suspicion of infection, and further investigation should be conducted. The presence of at least one confirmatory sign is associated with high diagnostic performance and is pathognomonic for the presence of fracture-related infection. This definition also guides the treatment of fracture-related infections. Fracture-related infections are a significant complication causing high morbidity in orthopedic trauma surgery. This study aims to compare the clinical outcomes of DAIR and implant removal/replacement methods used in the treatment of fracture-related infections, and to determine the infection-free fracture healing rates and the factors affecting treatment success.

Eligibility

Inclusion Criteria:

  • internal fixation after fracture
  • presence of fistula and/or sinus tract or purulent drainage with dehiscence at the incision site
  • at least 2 positive deep tissue cultures or at least 3 positive soft tissue cultures
  • early onset of symptoms (6 weeks)
  • DAIR or implant removal/replacement due to fracture-related infection

Exclusion Criteria:

  • Under 18 years old patients
  • prosthetic joint infection
  • only conservative treatment applied
  • pathological fracture due to primary bone tumor
  • simultaneous infection foci in the same extremity
  • fracture-related infection not confirmed by international consensus criteria
  • poor reduction after internal fixation
  • inappropriate or inadequate internal fixation
  • radiological images less than 1 year old
  • findings starting late (after 6 weeks)

Study details
    Orthopedic Surgery
    Fracture Related Infection
    Debridement
    Implant Retention
    Implant Removal/Replacement

NCT07669714

Antalya Health Sciences University

27 June 2026

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