A Phase 4 interventional study of Hyperbaric oxygen treatment and Standard of Care (Investigator Choice) in Necrotizing Soft Tissue Infection, sponsored by Ole Hyldegaard. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Ole Hyldegaard · Phase 4, Interventional, and Treatment
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.
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This study's planned enrollment of 1,480 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
standard of care (e.g. intensive care, surgery, antibiotics)
Other: Standard of Care (Investigator Choice)
standard of care (e.g. intensive care, surgery, antibiotics) + hyperbaric oxygen treatment
Drug: Hyperbaric oxygen treatment · Other: Standard of Care (Investigator Choice)
Patients will be randomized to either standard of care or standard of care + adjunctive sessions of HBO2 treatment consisting of 60-90 minutes (according to local protocols) 2.8ATA (284 kPa (≈18 m' seawater equivalent)) 100% oxygen breathing. The first session will be performed as soon as possible after randomization at the trial site, and at least within 12 hours from randomization. A minimum of three sessions will be performed within 48 hours after randomization. If the patient is considered clinical unstable after the initial three sessions (e.g. ongoing progression of the necrotising process or requiring intravenous blood pressure support in a dosage considered not related to sedation agents) additional sessions must be administered at a rate of one per approximately 24 hours, up to a maximum of five treatments. All sessions must be completed within a total timeframe of 96 hours from randomization.
Standard of care (e.g. intensive care, surgery, antibiotics)
Mortality
30-day all-cause mortality post-randomization
Time frame: 30-day post-randomization
Mortality
90-day all-cause mortality post-randomization
Time frame: 90-day post-randomization
Amputations
Amputation (y/n) within 7 days post-randomization
Time frame: 7 days post-randomization
Quality of life questionaire
Quality of life at Day 90 evaluated with the 5Q-5D-5L and WHO-DAS questionaire
Time frame: 90 days post-randomization
Days alive and out of hospital
Days alive and out of hospital in the 90-day period
Time frame: 90 days post-randomization
Ventilator-free days
Ventilator-free days within 7 days post-randomization
Time frame: 7 days post-randomization
Renal-replacement therapy
Need for renal-replacement therapy (y/n) within 7 days
Time frame: 7 days post-randomization
Safety - serious adverse events
Number of patients with one or more serious adverse events up to 24 hours after last treatment
Time frame: 24 hours after last treatment
Plan to share: Undecided
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Ole Hyldegaard