RecruitingPhase 4

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

Belgium1,480 participantsStarted 2026-04-04

Plain-language summary

Necrotizing soft-tissue infection (NSTI) is a rare, severe, fast-progressing bacterial infection within the soft tissue compartment. The NSTI mortality rate remain high and largely unaltered in the last decades. The standard of care in NSTI is multidisciplinary and includes surgery, intensive care, and broad-spectrum antibiotics. Hyperbaric oxygen (HBO2) treatment is an adjunctive treatment potentially improving survival, but is not standard of care in many centres, presumably as no evidence of its benefit from randomized clinical trial exists. The primary objective of this trial, HOT-NSTI, is to investigate the effect of adjunctive HBO2 treatment on 30-day all-cause mortality in patients with NSTI.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults (age ≥18 years) * Surgical confirmed NSTI (defined by perioperative tissue characteristics observed by the surgeon. The diagnosis is based on sign as necrotic or deliquescent soft tissue with widespread undermining of the surrounding tissue) Exclusion Criteria: * Contraindications for HBO2 treatment according to local protocol (e.g., undrained pneumothorax) * Confirmed pregnancy * Referred to palliative care * Previously randomized into the HOT-NSTI trial * Known objection by the patient to participate in the trial * Allergy against study drug

What they're measuring

Mortality

Timeframe: 30-day post-randomization

Trial details

NCT IDNCT07489274

SponsorOle Hyldegaard

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2033-04-30

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