Authorised Therapeutic use (Phase IV) Necrotizing soft-tissue infection

Adjunctive Hyperbaric Oxygen Treatment for Patients with Necrotizing Soft-Tissue Infection (HOT-NSTI trial)

EU CTIS ID: 2025-521368-37-00

What this study is testing

In effort of evaluating the efficacy of HBO2 treatment as an adjunctive treatment for patients with NSTI, we have initiated and designed the HOT-NSTI trial that will become the first randomized clinical trial assessing this objective. The purpose of the HOT-NSTI trial is to investigate the effect of adjunctive hyperbaric oxygen treatment on 30-day all-cause mortality in patients with NSTI.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join 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 likely can't join 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

The study team makes the final eligibility decision.

Where it's taking place

  • Australia
  • Canada

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Australia; Canada. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.