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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAntalya Health Sciences University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Under 18 years old patients

prosthetic joint infection

only conservative treatment applied

pathological fracture due to primary bone tumor

Trial 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.

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

  • DAIR

    Other intervention

    DAIR: Debridement, antibiotic retention and implant removal

  • Implant removal/replacement

    Other intervention

    implant removal/replacement

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: DAIR1 intervention
Group B: Implant removal/replacement1 intervention

Trial outcomes

Primary outcomes

1

Fracture healing rates

Infection-free fracture healing rates

Time frame
1 year

Secondary outcomes

1

Recurrence rate

Infection recurrence rate

Time frame
1 year
2

Union time

Time to union

Time frame
1 year

Other outcomes

Sponsors and contacts

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