Adding hyperbaric oxygen therapy to standard care for necrotizing soft-tissue infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Necrotizing soft-tissue infection is a rare, rapidly progressing bacterial infection with high short-term mortality despite prompt surgery, antibiotics, and intensive care. HOT-NSTI compares adjunctive hyperbaric oxygen treatment plus the investigator's choice of standard care versus standard care alone in adults with surgically confirmed NSTI. The trial's primary outcome is 30-day all-cause mortality, with patients enrolled at specialist centers that provide hyperbaric oxygen facilities. The sponsor and collaborators include academic and regional hospitals in Belgium and Denmark and the lead site is University Hospital Antwerpen.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital Antwerpen
  Antwerp, Edegem, Belgium Recruiting
• Haukeland University Hospital
  Bergen, Norway Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.