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

3. juli 2026 opdateret af: Antalya Health Sciences University

COMPARISON OF DEBRIDEMENT, ANTIBIOTIC, IMPLANT RETENTION (DAIR) AND IMPLANT EXCHANGE IN EARLY-STAGE FRACTURE-RELATED INFECTIONS: A RETROSPECTİVE COHORT STUDY

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

94

Kontakter og lokationer

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Studiesteder

      • Antalya, Tyrkiet (Türkiye)
        • University of Health Sciences, Antalya Training and Research Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
DAIR
DAIR: Debridement, antibiotic retention and implant removal
Implant removal/replacement
implant removal/replacement

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fracture healing rates
Tidsramme: 1 year
Infection-free fracture healing rates
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recurrence rate
Tidsramme: 1 year
Infection recurrence rate
1 year
Union time
Tidsramme: 1 year
Time to union
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Melih Unal, University of Health Sciences, Antalya Training and Research Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. april 2026

Primær færdiggørelse (Faktiske)

23. juni 2026

Studieafslutning (Faktiske)

1. juli 2026

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

22. juni 2026

Først opslået (Faktiske)

25. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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