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Recruiting NCT07489274

Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial).

Phase IV Interventional Necrotizing Soft Tissue Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyperbaric oxygen treatment, Standard of Care (Investigator Choice).
Who it may be relevant to
Registry conditions: Necrotizing Soft Tissue Infection. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial)

Overview

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.

Interventions

  • Drug Hyperbaric oxygen treatment
    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
  • Other Standard of Care (Investigator Choice)
    Standard of care (e.g. intensive care, surgery, antibiotics)

Primary outcome measures

  • Mortality [Time frame: 30-day post-randomization]
Secondary outcome measures (2)
  • Mortality [Time frame: 90-day post-randomization]
  • Amputations [Time frame: 7 days post-randomization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • University Hospital Antwerpen — Antwerp

Identifiers

NCT: NCT07489274 · 2025-521368-37-00 · 2025-521368-37-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗