Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07669714
Acronym
DAIR
Enrollment
94
Registered
2026-06-25
Start date
2026-04-16
Completion date
2026-07-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Debridement, Fracture Related Infection, Implant Removal/Replacement, Implant Retention, Orthopedic Surgery

Keywords

orthopedic surgery, fracture-related infection, debridement, implant retention, implant removal/replacement

Brief summary

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.

Detailed 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.

Interventions

OTHERDAIR

DAIR: Debridement, antibiotic retention and implant removal

OTHERImplant removal/replacement

implant removal/replacement

Sponsors

Antalya Health Sciences University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Fracture healing rates1 yearInfection-free fracture healing rates

Secondary

MeasureTime frameDescription
Recurrence rate1 yearInfection recurrence rate
Union time1 yearTime to union

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORMelih Unal

University of Health Sciences, Antalya Training and Research Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026