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Standard of Care (Investigator Choice) / Necrotizing Soft Tissue Infection / Hyperbaric oxygen treatment · Phase 4 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 4 randomized controlled trial investigating adjunctive hyperbaric oxygen treatment for necrotizing soft-tissue infection, currently recruiting participants. No results have been posted in this registry record, and the study remains in active recruitment with an estimated enrollment of 1480 participants.
Phase 4, Interventional, Randomized, Parallel, Open label, Treatment purpose. Necrotizing Soft Tissue Infection; age from 18 Years. Intervention: Standard of care + hyperbaric oxygen treatment. Compared with: Standard of care — Active Comparator. n = 1,480. 2 sites: Belgium, Norway.
This is a registered Phase 4 randomized controlled trial investigating adjunctive hyperbaric oxygen treatment for necrotizing soft-tissue infection, currently recruiting participants. No results have been posted in this registry record, and the study remains in active recruitment with an estimated enrollment of 1480 participants.
No efficacy, harm, or outcome data are presented in this record
The source did not state who this applies to in practice.
This is a recruiting Phase 4 trial registration with no results posted; it describes a planned intervention but carries no outcome data, efficacy claims, or evidence of benefit.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07489274). This is a study registration, not published results. Lead sponsor: Ole Hyldegaard. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 1480 participants (ESTIMATED). Conditions: Necrotizing Soft Tissue Infection. Interventions: DRUG: Hyperbaric oxygen treatment; OTHER: Standard of Care (Investigator Choice). Primary outcome measures: Mortality , 30-day post-randomization. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.