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

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What is this study about?

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.

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.

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.

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

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.

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.

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Karolinska University Hospital	Solna	Sweden
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Turku University Hospital	Turku	Finland
Ziekenhuis Oost Limburg	Genk	Belgium
Rigshospitalet	Copenhagen	Denmark
Hlrhd Bwlovw Hm	Bergen	Norway
Ulueumunpu Ok Anwzjtz	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.09.2025
Denmark	Not yet recruiting	01.09.2025
Finland	Not yet recruiting	01.09.2025
Norway	Not yet recruiting	01.09.2025
Sweden	Not yet recruiting	01.09.2025

Trial locations

Investigated drugs:

Oxygen

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.

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.

Trial ID:

2025-521368-37-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?