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.

NCT Number	NCT07489274
Lead Sponsor	Ole Hyldegaard Collaborators: Københavns Universitet, AZ Sint-Lucas Brugge, Ziekenhuis Oost-Limburg, University Hospital, Antwerp, Rigshospitalet, Denmark, Oslo University Hospital, Haukeland University Hospital, Turku University Hospital, Karolinska University Hospital
Conditions	Necrotizing Soft Tissue Infection
Enrollment	1,480 participants
Start Date	2026-04-04
Primary Completion	2033-04-30 (estimated)
Study Completion	2033-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-30