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

June 22, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DAIR
Other: DAIR
DAIR: Debridement, antibiotic retention and implant removal
Implant removal/replacement
Other: Implant removal/replacement
implant removal/replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture healing rates
Time Frame: 1 year
Infection-free fracture healing rates
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate
Time Frame: 1 year
Infection recurrence rate
1 year
Union time
Time Frame: 1 year
Time to union
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Health Sciences University

Investigators

  • Principal Investigator: Melih Unal, University of Health Sciences, Antalya Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2026

Primary Completion (Estimated)

June 23, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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