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Condition / disease
Location
Status: Recruiting

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

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.

Participants needed: 1,480
Trial details
Phase: Phase 4Age: 18+Biological sex: AllType: InterventionalSponsor: Ole HyldegaardUpdated: Apr 30, 2026Locations: 1
Eligibility criteria

Adults (age ≥18 years) [+1]

Contraindications for HBO2 treatment according to local protocol (e.g., undraine... [+5]