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NCT Number: NCT07489274

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

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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Key information

Conditions

Necrotizing Soft Tissue Infection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Antwerpen, Antwerp, Edegem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperbaric oxygen treatment

Drug

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 (Investigator Choice)

Other

Standard of care (e.g. intensive care, surgery, antibiotics)

Primary outcomes

  1. Mortality

    Time frame: 30-day post-randomization

    30-day all-cause mortality post-randomization

Secondary outcomes

  1. Mortality

    Time frame: 90-day post-randomization

    90-day all-cause mortality post-randomization

  2. Amputations

    Time frame: 7 days post-randomization

    Amputation (y/n) within 7 days post-randomization

Other outcomes

  1. Quality of life questionaire

    Time frame: 90 days post-randomization

    Quality of life at Day 90 evaluated with the 5Q-5D-5L and WHO-DAS questionaire

  2. Days alive and out of hospital

    Time frame: 90 days post-randomization

    Days alive and out of hospital in the 90-day period

  3. Ventilator-free days

    Time frame: 7 days post-randomization

    Ventilator-free days within 7 days post-randomization

  4. Renal-replacement therapy

    Time frame: 7 days post-randomization

    Need for renal-replacement therapy (y/n) within 7 days

  5. Safety - serious adverse events

    Time frame: 24 hours after last treatment

    Number of patients with one or more serious adverse events up to 24 hours after last treatment

Sponsors and collaborators

Lead sponsor

Ole Hyldegaard

Other

Collaborators

  • AZ Sint-Lucas Brugge
  • Haukeland University Hospital
  • Karolinska University Hospital
  • Københavns Universitet
  • Oslo University Hospital
  • Rigshospitalet, Denmark
  • Turku University Hospital
  • University Hospital, Antwerp
  • Ziekenhuis Oost-Limburg

Registry information

Official study title

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

Acronym: HOT-NSTI

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Mar 24, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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