Evaluating Hyperbaric Oxygen as an Added Treatment for Adults With Necrotizing Soft Tissue Infection to Improve Survival

What this Trial Is About

Necrotizing soft-tissue infection NSTI is a rare and severe bacterial infection that progresses rapidly within soft tissues, with a high mortality rate that has not improved in recent decades. Researchers are studying the effect of adding hyperbaric oxygen HBO2 treatment to the standard care, which includes surgery, intensive care, and broad-spectrum antibiotics, to see if it can reduce death rates within 30 days of treatment. Participants will be randomly assigned to receive either the standard care alone or standard care plus HBO2 treatment. HBO2 sessions involve breathing 100% oxygen at high pressure for 60 to 90 minutes, starting as soon as possible and within 12 hours after randomization. At least three HBO2 sessions will be given within 48 hours, with up to five sessions allowed within 96 hours if the patient remains unstable. During the study, researchers will monitor survival rates at 30 and 90 days, and track amputations within 7 days after treatment. Participants will receive intensive medical care including surgery and antibiotics, and the study will assess how the addition of HBO2 influences outcomes. The trial will continue until June 2033, and participants will be carefully observed throughout the treatment and follow-up periods.

Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).