An observational study in Orthopedic Surgery, Fracture Related Infection and Debridement, sponsored by Antalya Health Sciences University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Antalya Health Sciences University · Observational
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.
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.
Antalya Health Sciences University is the lead sponsor of 15 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study planned to include over 18 years old patients who underwent internal fixation after fracture, had a fistula and/or sinus tract, or purulent drainage with incision dehiscence, at least 2 positive deep tissue cultures or at least 3 positive soft tissue cultures, whose findings started early (6 weeks), and who underwent DAIR or implant removal/replacement due to fracture-related infection.
Exclusion Criteria:
Other: DAIR
Other: Implant removal/replacement
DAIR: Debridement, antibiotic retention and implant removal
implant removal/replacement
Fracture healing rates
Infection-free fracture healing rates
Time frame: 1 year
Recurrence rate
Infection recurrence rate
Time frame: 1 year
Union time
Time to union
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Antalya Health Sciences University