RecruitingRare disease

Evaluating Hyperbaric Oxygen Treatment in Addition to Standard Care for Patients with Necrotizing Soft-Tissue Infection

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Necrotizing Soft-Tissue Infection, a severe condition where bacteria cause tissue death under the skin. The research evaluates the effectiveness of Hyperbaric Oxygen treatment, which involves breathing pure oxygen in a special pressurized chamber, as an additional therapy alongside standard medical care.

The treatment being tested uses Medical Liquid Oxygen administered through inhalation in specialized chambers. Patients may receive up to two treatments per day for a maximum of four days. This therapy is given in addition to the usual medical care that all patients with this infection normally receive.

The main goal of this research is to determine if adding hyperbaric oxygen therapy to standard treatment helps improve survival rates in people with necrotizing soft-tissue infection. The study will monitor patients' progress and overall health outcomes to evaluate how well this additional treatment works compared to standard care alone.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial confirmation
Your participation begins after surgical confirmation of necrotizing soft-tissue infection (NSTI). This is a serious infection that damages the soft tissues beneath the skin.
A surgeon will verify the diagnosis by examining the affected tissue during surgery.
Step 2
Treatment assignment
You will be randomly assigned to receive either standard treatment alone or standard treatment plus hyperbaric oxygen therapy (HBO2).
The hyperbaric oxygen is administered as a medicinal gas through inhalation in a specialized chamber.
Step 3
Initial 7-day period
During the first 7 days, your medical team will monitor:
- Need for ventilator support
- Need for kidney support treatment
- Any surgical procedures including potential amputations
Step 4
30-day follow-up
Your health status will be monitored for the first 30 days after starting the study.
The medical team will track your overall recovery progress during this period.
Step 5
90-day assessment
At day 90, you will complete two quality of life surveys:
- The 5Q-5D-5L questionnaire
- The WHO-DAS questionnaire
The medical team will also calculate how many days you spent outside the hospital during the 90-day period.
Step 6
Safety monitoring
Throughout the study, the medical team will monitor and record any serious side effects, particularly within 24 hours after each treatment session.

Who can join the trial?

6 criteria

Must be 18 years of age or older
Must have a surgically confirmed necrotizing soft-tissue infection (NSTI), which means:
- The surgeon must observe dead (necrotic) or deteriorating soft tissue during surgery
- The infection must show signs of spreading beneath the surrounding tissue
- Both men and women can participate
- Must be able to undergo surgery for confirmation of the diagnosis
- Must be willing to receive additional oxygen therapy treatment if selected

Who cannot join the trial?

13 criteria

Age below 18 years old
Inability to receive hyperbaric oxygen therapy (treatment in a pressurized chamber with 100% oxygen) due to medical contraindications
Pregnancy or suspected pregnancy
Previous participation in this clinical trial
Current participation in other clinical trials
Presence of claustrophobia (fear of confined spaces) that would prevent treatment in the hyperbaric chamber
Inability to provide informed consent
Presence of untreated pneumothorax (collapsed lung with air in chest cavity)
Active chemotherapy treatment
Severe respiratory failure (severe breathing problems requiring intensive support)
Unstable vital signs that prevent safe transport to hyperbaric chamber
History of previous adverse reactions to hyperbaric oxygen therapy
Presence of implanted devices that are not certified for use in hyperbaric chambers

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Az St-Jan Brugge-Oostende A.V.
Verified
Brugge, Belgium
Helse Bergen HF
Verified
Bergen, Norway
Karolinska University Hospital
Verified
Solna, Sweden

Trial locations

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Investigated drugs

Hyperbaric Oxygen Therapy (HBO2) Hyperbaric oxygen therapy involves breathing pure oxygen in a pressurized chamber. During this treatment, patients are placed in a special room or chamber where the air pressure is increased to several times higher than normal atmospheric pressure. Under these conditions, the lungs can gather much more oxygen than would be possible breathing pure oxygen at normal air pressure. This treatment is used alongside standard medical care to help fight serious infections by increasing oxygen delivery to infected tissues.

Oxygen

What is already known about the treatment

Hyperbaric Oxygen (HBO2) - A medical treatment where pure oxygen is administered to patients in a pressurized chamber, allowing the oxygen to dissolve at higher concentrations in the blood. This therapy is being investigated as an adjunctive treatment for necrotizing soft-tissue infections (NSTI), where it may help combat bacterial growth and enhance tissue healing by increasing oxygen levels in damaged tissues. The treatment involves patients breathing 100% oxygen while inside a specialized chamber at pressures greater than normal atmospheric pressure, typically administered in sessions lasting about 90 minutes. HBO2 therapy is classified as a physical treatment modality and works by increasing plasma oxygen concentration, promoting the formation of new blood vessels, and enhancing the body's natural healing mechanisms.

Investigated diseases

Necrotizing soft-tissue infection – A severe bacterial infection that spreads quickly through the soft tissues of the body, including skin, fat, and muscles. The infection causes the affected tissue to die rapidly as it progresses deeper into the body. The condition typically begins with severe pain in the affected area, which may appear red, warm, and swollen. As the infection advances, the skin may turn purple or dark, and blisters filled with dark fluid may form. The infection can spread within hours, causing symptoms like fever, weakness, and severe pain that seems worse than the appearance of the affected area would suggest.