Necrotizing soft-tissue infection (NSTI), in the tabloid media referred to as the flesh-eating bacteria, is a rare, severe, fast-progressing bacterial infection within the soft tissue compartment. The burden of disease is immense with high morbidity and mortality rates showing one-in-four patients not surviving three months after diagnosis. Likewise, survivors must often cope with impaired quality of life and physical limitations.
The mortality rates have remained high and largely unaltered in the last decades. Some observational studies have demonstrated adjunctive hyperbaric oxygen (HBO2) treatment to improve survival and potentially reduce the risk of amputations in this severe and life-threatening disease, but the treatment is not universally considered standard of care as no evidence of its benefit from randomized clinical trial exits.
In effort of evaluating the efficacy of HBO2 treatment as an adjunctive treatment on mortality for patients with NSTI, we have initiated and designed the HOT-NSTI trial that will become the first randomized clinical trial assessing this objective. We hypothesize that adjunctive HBO2 treatment will reduce the 30-day all-cause mortality in patients with NSTI as compared to standard of care.
In the HOT-NSTI trial, patients with NSTI will be randomized to receive standard-of-care or standard-of-care + adjunctive HBO2 treatment. HBO2 treatment will be given to the randomized patients in up to five sessions during the first days of their critical illness while still receiving intensive care therapy. Patients will be followed for their outcomes of interest including survival, amputations, and quality of life.
For further details on the trial including eligibility criteria, intervention protocol and outcomes, please see the approved study protocol in CTIS.