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

NCT07669714 | Completed

• 1 other identifier: 6/20
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Fracture healing rates

  Infection-free fracture healing rates

  1 year

Secondary Outcomes (2)

• Recurrence rate

  1 year

• Union time

  1 year

Study Arms (2)

DAIR

Other: DAIR

Implant removal/replacement

Other: Implant removal/replacement

Interventions

DAIR OTHER

DAIR: Debridement, antibiotic retention and implant removal

DAIR

Implant removal/replacement OTHER

implant removal/replacement

Implant removal/replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Antalya Health Sciences University: lead

Study Sites (1)

University of Health Sciences, Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40945224 BACKGROUND

MeSH Terms

Interventions

Device Removal; Replantation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Transplantation

Study Officials

• Melih Unal

  University of Health Sciences, Antalya Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 25, 2026
• Study Start: April 16, 2026
• Primary Completion: June 23, 2026
• Study Completion: July 1, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)