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Table 3 Outcome parameters and assessments of both randomized trials

From: Study protocol: short against long antibiotic therapy for infected orthopedic sites — the randomized-controlled SALATIO trials

Outcome(s)

Primary objectives:

• Clinical remission related to the duration of total, post-debridement, antibiotic use

• Microbiological recurrence in relation to the total, post-debridement, antibiotic use

Secondary objectives:

- Description of all clinical failures of any sort

- Adverse events in each study arm, and in relation to the antibiotics used

- Length of hospital stay in acute care surgery (without rehabilitation)

  1. Assessment of primary outcomes: Remission and microbiological recurrences of treated orthopedic infection at 12 months — Judged by local wound healing (healed vs delayed wound healing according to Reference [4]). Remission is defined as the absence of clinical, anamnestic, radiologic, or laboratory signs of former infection.
  2. Assessment of other outcomes of interest: Secondary objectives are adverse events and length of hospital stay. We will note them during the study
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Trials

ISSN: 1745-6215