Orthopedic SurgeryDAIRNCT07669714
Comparison of Debridement, Antibiotic, Implant Retention and Implant Exchange in Early-stage Fracture-related Infections
An observational study of Orthopedic Surgery and Fracture Related Infection, run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Surgery, Fracture Related Infection, Debridement
- What is being tested?
- DAIR and Implant removal/replacement
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2026to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- poor reduction after internal fixation
- inappropriate or inadequate internal fixation
- radiological images less than 1 year old
- findings starting late (after 6 weeks)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Antalya Training and Research Hospital
Antalya
About this study
Official title: 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.
Read the 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.
- Conditions
- Orthopedic Surgery, Fracture Related Infection, Debridement, Implant Retention, Implant Removal/Replacement
- Being tested
- DAIR, Implant removal/replacement
- Keywords
- orthopedic surgery, fracture-related infection, debridement, implant retention, implant removal/replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAIROther
DAIR: Debridement, antibiotic retention and implant removal
Implant removal/replacementOther
implant removal/replacement
| Study group | Role | What they receive |
|---|---|---|
| DAIR | Not described Receives: Other: DAIR | |
| Implant removal/replacement | Not described Receives: Other: Implant removal/replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture healing rates
Infection-free fracture healing rates
Measured: 1 year
Secondary outcomes (2)
Recurrence rate
Infection recurrence rate
Measured: 1 year
Union time
Time to union
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start16 Apr 2026
- Primary completion23 Jun 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthopedic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melih Unal, Principal investigator, University of Health Sciences, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669714
- Sponsor's protocol ID
- 6/20
- Acronym
- DAIR
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cury GCT, Guidoni PB, Ikeda LH, Ferreira CCUAC, Goncalves MAM, Leonhardt MC, Lima ALM, Dos Santos Silva J, Kojima KE. Outcomes of DAIR for early fracture related infection: Clinical remission, recurrence, and bone healing in a retrospective cohort. Injury. 2025 Nov;56(11):112749. doi: 10.1016/j.injury.2025.112749. Epub 2025 Sep 5.
PubMed 40945224
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF DEBRIDEMENT, ANTIBIOTIC, IMPLANT RETENTION (DAIR) AND IMPLANT EXCHANGE IN EARLY-STAGE FRACTURE-RELATED INFECTIONS: A RETROSPECTİVE COHORT STUDY
- ClinicalTrials.gov ID
- NCT07669714
- Acronym / sponsor ID
- DAIR / 6/20
- Conditions
- Orthopedic Surgery, Fracture Related Infection, Debridement, Implant Retention, Implant Removal/Replacement
- Keywords
- orthopedic surgery, fracture-related infection, debridement, implant retention, implant removal/replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Antalya Health Sciences UniversityUniversity, hospital or other
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 23 Jun 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DAIR | – | Other: DAIR |
| Implant removal/replacement | – | Other: Implant removal/replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DAIRDAIR: Debridement, antibiotic retention and implant removal | Other | DAIR |
| Implant removal/replacementimplant removal/replacement | Other | Implant removal/replacement |
Primary outcome
Fracture healing rates
Time frame: 1 year
Infection-free fracture healing rates
2 secondary outcomes
Recurrence rate
Time frame: 1 year
Union time
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 40945224Cury GCT, Guidoni PB, Ikeda LH, Ferreira CCUAC, Goncalves MAM, Leonhardt MC, Lima ALM, Dos Santos Silva J, Kojima KE. Outcomes of DAIR for early fracture related infection: Clinical remission, recurrence, and bone healing in a retrospective cohort. Injury. 2025 Nov;56(11):112749. doi: 10.1016/j.injury.2025.112749. Epub 2025 Sep 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melih Unal principal investigator
University of Health Sciences, Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Surgery and Fracture Related Infection, run by Antalya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fracture healing rates (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07669714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.