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
8 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 and severe bacterial infection that progresses rapidly within soft tissues, with a high mortality rate that has not improved in recent decades. Researchers are studying the effect of adding hyperbaric oxygen (HBO2) treatment to the standard care, which includes surgery, intensive care, and broad-spectrum antibiotics, to see if it can reduce death rates within 30 days of treatment. Participants will be randomly assigned to receive either the standard care alone or standard care plus HBO2 treatment. HBO2 sessions involve breathing 100% oxygen at high pressure for 60 to 90 minutes, starting as soon as possible and within 12 hours after randomization. At least three HBO2 sessions will be given within 48 hours, with up to five sessions allowed within 96 hours if the patient remains unstable. During the study, researchers will monitor survival rates at 30 and 90 days, and track amputations within 7 days after treatment. Participants will receive intensive medical care including surgery and antibiotics, and the study will assess how the addition of HBO2 influences outcomes. The trial will continue until June 2033, and participants will be carefully observed throughout the treatment and follow-up periods.
CONDITIONS
Brief 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 aged 18 years or older
- Surgically confirmed necrotizing soft-tissue infection based on tissue characteristics observed during surgery
You will not qualify if you...
- Contraindications for hyperbaric oxygen treatment according to local protocol (e.g., undrained pneumothorax)
- Confirmed pregnancy
- Receiving palliative care
- Previously participated in this HOT-NSTI trial
- Known objection by the patient to participate
- Allergy to the study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to 4 days
Participants receive standard of care with or without adjunctive hyperbaric oxygen treatment consisting of multiple sessions within 96 hours from randomization.
At least 3 hyperbaric oxygen sessions within 48 hours and up to 5 sessions within 96 hours
Duration - Up to 90 days post-randomization
Participants are monitored for outcomes including mortality and amputations following treatment.
Visits up to 90 days post-randomization
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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