Antibiotic Side Effect, Infection, Surgical Site, Orthopedic Devices Associated With Misadventures
Conditions
Keywords
Orthopedic infectionsT, Duration, Antibiotic Therapy, Randomized-Controlled Trial
Brief summary
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.
Detailed 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.
Interventions
DRUGAntibiotic
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.
Sponsors
Balgrist University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission related to the duration of total, postdebridement, antibiotic use | 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery | 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) |
| Microbiological recurrence in relation to the total, postdebridement, antibiotic use | 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery | Recurrence of infection, with the same pathogens, after completing the antibiotic treatment for the index infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay in acute care surgery (without rehabilitation) | 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery | The duration of the hospital stay for every episode in both randomizing arm |
| Description of all clinical failures of any sort | 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery | Need for hospitalisation or revision surgery for any non-infectious failures related to the operation wound (hematoma, seroma, internal (closed) fractures, dislocation of implants) |
| Adverse events in each study arm, and in relation to the antibiotics used | 6 weeks postoperatively, or 1 year postoperatively in case of implant-related orthopedic surgery | 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. |
Countries
Switzerland
Outcome results
None listed