Actively Recruiting
Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).
Led by Ole Hyldegaard · Updated on 2026-04-30
1480
Participants Needed
1
Research Sites
377 weeks
Total Duration
On this page
Sponsors
O
Ole Hyldegaard
Lead Sponsor
K
Københavns Universitet
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (age 6518 years)
- Surgically confirmed necrotizing soft-tissue infection based on tissue characteristics seen by the surgeon
You will not qualify if you...
- Contraindications for hyperbaric oxygen treatment according to local guidelines (e.g., undrained pneumothorax)
- Confirmed pregnancy
- Receiving palliative care
- Previously enrolled in the HOT-NSTI trial
- Patient has objected to participate in the trial
- Allergy to the study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Antwerpen
Antwerp, Edegem, Belgium, 2650
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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