Anders Kjellberg

Background: Necrotizing soft tissue infections (NSTI) is a debilitating and potentially life-threateningcondition that needs urgent multidisciplinary management including broad spectrum antibiotics, surgery, andintensive care support. Hyperbaric oxygen therapy (HBOT) is used as an adjuvant treatment since 50+years but evidence is limited to small cohorts and retrospective data. Current evidence suggests a strongcorrelation between HBOT and decreased mortality [RR = 0.5, 95% CI (0.4, 0.7), p0.05], but there is stillclinical equipoise regarding the causal effect. Aim: We aim to plan and conduct an international multicenter randomized trial including 1400 patients incollaboration with 15+ centers in Europe, Canada, Australia, and New Zealand. Hypothesis: We hypothesize that the use of adjuvant HBOT in NSTI will increase the effect of antibiotics,reduce multi-organ failure and as a result reduce mortality. Objective: The primary objective is to evaluate if HBOT can reduce 30-day mortality in NSTI. Secondary objectives include evaluation if HBOT can reduce multi-organ failure, ICU-mortality, 90-daymortality and amputations. Other objectives include evaluation of safety, exploration of mechanisms, long term outcome, quality of life and health economic aspects. Trial design: International multicenter, parallel-arms, single-blinded, RCT conducted in compliance withInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use(ICH)-Good Clinical Practice (ICH-GCP). Primary endpoint is 30 day mortality.