Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Age ≥ 18 years on admission
- Orthopedic bone and implant infections including musculoskeletal grafts
- Intraoperative debridement with any surgical technique
- 12 months of scheduled follow-up from hospitalization
- Bacterial orthopedic infections of any nature
- First or second episode of infection
Exclusion Criteria:
- Mycobacterial, fungal, nocardial, and Actinomyces infections
- Purely soft tissue infections
- Non-resected cancer in the infection site
- Purely intrasynovial infections (native joint septic arthritis)
- More than three debridements performed for infection
- Absence of at least one surgical intraoperative debridement
- Spine infections (investigated in another trial)10
- Diabetic foot infections (investigated in another trial)7
- Documented endocarditis according to the Duke criteria
- At least 2 prior infection episodes at the actual infection site