Adding hyperbaric oxygen therapy to standard care for necrotizing soft-tissue infection
Adjunctive Hyperbaric Oxygen Treatment for Patients With Necrotizing Soft-Tissue Infection (HOT-NSTI Trial)
This trial will test if giving hyperbaric oxygen therapy in addition to surgery, antibiotics, and intensive care helps adults with confirmed necrotizing soft-tissue infection survive the first 30 days.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1480 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Antwerp, Edegem) |
| Trial ID | NCT07489274 on ClinicalTrials.gov |
What this trial studies
Necrotizing soft-tissue infection is a rare, rapidly progressing bacterial infection with high short-term mortality despite prompt surgery, antibiotics, and intensive care. HOT-NSTI compares adjunctive hyperbaric oxygen treatment plus the investigator's choice of standard care versus standard care alone in adults with surgically confirmed NSTI. The trial's primary outcome is 30-day all-cause mortality, with patients enrolled at specialist centers that provide hyperbaric oxygen facilities. The sponsor and collaborators include academic and regional hospitals in Belgium and Denmark and the lead site is University Hospital Antwerpen.
Who should consider this trial
Good fit: Adults aged 18 or older with surgically confirmed necrotizing soft-tissue infection who can receive hyperbaric oxygen and who are not pregnant, not referred to palliative care, and provide consent are ideal candidates.
Not a fit: Patients with contraindications to hyperbaric oxygen (for example an undrained pneumothorax), confirmed pregnancy, those already in palliative care, or those who decline participation are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, adding hyperbaric oxygen could reduce early deaths and improve recovery for patients with necrotizing soft-tissue infection.
How similar studies have performed: Observational and non-randomized reports have suggested potential benefit from hyperbaric oxygen in NSTI, but randomized trial evidence has been lacking until now.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Antwerp, Edegem
- University Hospital Antwerpen — Antwerp, Edegem, Belgium (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.