Efficacy of hyperbaric oxygen as adjuvant treatment for necrotizing soft tissue infection

Background: Necrotizing soft tissue infections (NSTI) is a debilitating and potentially lifethreatening condition that needs urgent multidisciplinary management including broad spectrum antibiotics, surgery, and intensive care support.

Hyperbaric oxygen therapy (HBOT) is used as an adjuvant treatment since 60-years but evidence is limited to small cohorts and retrospective data.

Current evidence suggests a strong correlation between HBOT and decreased mortality [RR = 0.522, 95% CI (0.403, 0.677), p < 0.05], but there is still clinical equipoise regarding the causal effect.Aim: We aim to plan and conduct an international multicenter randomized controlled trial (RCT) including 1300 patients in collaboration with 15+ centers.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, ICUmortality, 90-day mortality 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 with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use (ICH)-Good Clinical Practice (ICH-GCP).