The investigators will perform two concomitant RCTs, depending on the presence of infected osteosynthesis material at enrolment: \- SALATIO 1. Infected implant not removed (or new material inserted): Randomization 6 vs. 12 weeks (+/- 5 days) of total antibiotic therapy counted since the first debridement for infection. Early switch to oral targeted therapy. \- SALATIO 2. Infected implant without residual material (definitive removal or within the interval of a two-stage exchange): Randomization 3 vs. 6 weeks (+/- 5 days) of total antibiotic therapy counted since the first debridement for infection. Early switch to oral targeted therapy.
The optimal duration of postoperative, systemic antibiotic therapy for implant-related orthopedic infections, with or without implant removal, is unknown. Retrospective studies suggest that a maximum duration of 6 weeks is not inferior to longer administrations; even if the infected implants are kept in place or during a one-stage exchange. Prospective-randomized trials (RCT) suggest that even shorter durations, such 3 or 4 weeks, are possible, when the implant is removed. Likewise, in prospective studies, 6 or 8 weeks of systemic antibiotics are not inferior to the current 12 weeks during DAIR (debridement, antibiotic and implant retention), or during the one-stage exchange; except for one single RCT suggesting a better outcome for 12 weeks in the substrata of arthroplasty infections undergoing the DAIR procedure. However, these RCTs concern selected branches of orthopedic surgery; especially prosthetic joint infections. The investigators intend to expand these evaluations to all fields of orthopedic and hand surgery. The only exceptions would be spine surgery, for which a multicenter, separate RCT is already under way (SASI-trials). The second exception would be the treatment of implant-free diabetic foot infections, for which two RCTs are underway.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
495
The investigators will perform two concomitant RCTs, depending on the presence of infected osteosynthesis material at enrolment: \- SALATIO 1. Infected implant not removed (or new material inserted): Randomization 6 vs. 12 weeks (+/- 5 days) of total antibiotic therapy counted since the first debridement for infection. Early switch to oral targeted therapy. \- SALATIO 2. Infected implant without residual material (definitive removal or within the interval of a two-stage exchange): Randomization 3 vs. 6 weeks (+/- 5 days) of total antibiotic therapy counted since the first debridement for infection. Early switch to oral targeted therapy.
Balgrist University Hospital
Zurich, Switzerland
Clinical remission related to the duration of total, postdebridement, antibiotic use
Clinical assessment during routine surgical controls. Definition of clinical failure accoding to to sandard criteria in the literature (surgical revision, pain, local inflammation, discharge, several deep intraoperative bacterial tissue samples)
Time frame: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery
Microbiological recurrence in relation to the total, postdebridement, antibiotic use
Recurrence of infection, with the same pathogens, after completing the antibiotic treatment for the index infection
Time frame: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery
Description of all clinical failures of any sort
Need for hospitalisation or revision surgery for any non-infectious failures related to the operation wound (hematoma, seroma, internal (closed) fractures, dislocation of implants)
Time frame: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery
Adverse events in each study arm, and in relation to the antibiotics used
All adverse events during the therapy and follow-up time , with an emphasis on antibiotic-related adverse events (according to medical judgement). Numbers and descriptions.
Time frame: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery
Length of hospital stay in acute care surgery (without rehabilitation)
The duration of the hospital stay for every episode in both randomizing arm
Time frame: 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery
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