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

Recruiting now · Phase 4

Conditions studied: Necrotizing Soft Tissue Infection

In brief

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.

Key facts

Study ID

NCT07489274

Run by

Ole Hyldegaard

People needed

1480

Starts

2026-04-04

Expected to finish

2033-06-30

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University Hospital Antwerpen — Antwerp, Edegem, Belgium (enrolling)

Full record on ClinicalTrials.gov

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