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

NCT07489274 | Recruiting Phase 4

• 1 other identifier: 2025-521368-37-00
• Study Type: interventional
• Target: 1,480
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Soft Tissue Infection

Keywords

NSTI; Sepsis; clinical trial; Hyperbaric Oxygen Treatment; Hyperbaric Oxygen Therapy; Necrotizing soft tissue infection

Outcome Measures

Primary Outcomes (1)

• Mortality

  30-day all-cause mortality post-randomization

  30-day post-randomization

Secondary Outcomes (2)

• Mortality

  90-day post-randomization

• Amputations

  7 days post-randomization

Other Outcomes (5)

• Quality of life questionaire

  90 days post-randomization

• Days alive and out of hospital

  90 days post-randomization

• Ventilator-free days

  7 days post-randomization

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

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

Other: Standard of Care (Investigator Choice)

Standard of care + hyperbaric oxygen treatment

EXPERIMENTAL

standard of care (e.g. intensive care, surgery, antibiotics) + hyperbaric oxygen treatment

Drug: Hyperbaric oxygen treatment; Other: Standard of Care (Investigator Choice)

Interventions

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 + hyperbaric oxygen treatment

Standard of Care (Investigator Choice) OTHER

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

Standard of care; Standard of care + hyperbaric oxygen treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University Hospital Antwerpen

Antwerp, Edegem, 2650, Belgium

RECRUITING

Related Links

• Official trial website

MeSH Terms

Conditions

Sepsis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, Ph.D., DMSci

Model Details: Investigator-initiated, international, multicentre, superiority, randomized, open-label, clinical trial

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 24, 2026
• Study Start: April 4, 2026
• Primary Completion (Estimated): April 30, 2033
• Study Completion (Estimated): June 30, 2033
• Last Updated: April 30, 2026

Record last verified: 2026-03

Locations

BE (1)