Hyperbaric Oxygen Therapy for Flesh-Eating Disease

Overseen By Kendra Selby

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spectrum Health Hospitals

Disqualifiers: Pediatric, Pregnant, Unlikely to survive, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether hyperbaric oxygen therapy can help treat necrotizing infections, severe conditions where flesh-eating bacteria destroy body tissue. Researchers aim to determine if this oxygen treatment can improve survival rates and reduce complications compared to standard treatments. They are also assessing whether faster diagnosis and treatment eliminate the need for this therapy. Suitable participants include adults diagnosed with necrotizing fasciitis or similar infections.

As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could lead to faster and more effective treatments for severe infections.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that hyperbaric oxygen therapy is safe for treating necrotizing infections?

Research has shown that hyperbaric oxygen therapy (HBOT) is usually well-tolerated by patients. Some studies suggest that HBOT might extend the lives of those with severe soft tissue infections. However, it does not appear to reduce the need for amputations or lower the risk of in-hospital mortality.

Most individuals tolerate the treatment well, though side effects can occur. These may include ear pain or slight changes in vision, but serious issues are rare. While studies generally report positive outcomes, it is advisable to consult the trial team for more information about potential side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for flesh-eating disease, or necrotizing fasciitis, involve antibiotics and surgical removal of dead tissue. However, hyperbaric oxygen therapy is garnering interest because it delivers pure oxygen in a pressurized chamber, boosting oxygen levels in the blood, which helps fight infection and promotes healing. Researchers are excited about this approach because it may improve patient outcomes by reducing mortality and complications, and potentially shortening hospital stays. Unlike the conventional treatments, which primarily focus on cutting out infected tissue, this therapy could enhance recovery by improving tissue oxygenation and aiding the body's natural healing processes.

What evidence suggests that hyperbaric oxygen therapy is effective for necrotizing infections?

Studies have shown that hyperbaric oxygen therapy (HBOT) can help people with flesh-eating diseases, like necrotizing fasciitis, live longer and preserve their limbs. Research indicates that HBOT not only improves survival rates but also reduces the need for amputations. A review of several studies found that patients receiving HBOT had better outcomes, with lower death rates and fewer complications. Another study noted that while HBOT might lead to longer hospital stays, it significantly reduces the risk of death and major surgeries. This trial will evaluate whether adding HBOT to standard care improves mortality in patients with necrotizing fasciitis and necrotizing soft tissue infections. Another arm will assess if faster diagnosis to debridement times negate the need for HBOT treatments. These findings suggest that HBOT could be a valuable addition to the usual treatment for these serious infections. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with severe skin and muscle infections known as necrotizing fasciitis or soft tissue infections. Participants must meet certain health standards to be included, but specific inclusion criteria are not listed.

Inclusion Criteria

Patient or advocate is able to sign consent

I am 18 years old or older.

I have been diagnosed with a severe skin infection that required surgery.

Exclusion Criteria

Pregnant patients

I am a child or teenager.

I am not expected to survive or cannot undergo surgery to remove damaged tissue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hyperbaric oxygen treatment in conjunction with standard care to improve mortality and morbidity in necrotizing soft tissue infections

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Hyperbaric Oxygen Therapy

Trial Overview The study is testing if hyperbaric oxygen therapy can improve survival and recovery in patients with flesh-eating disease compared to standard treatments alone. It also examines if quick surgery might make this therapy unnecessary.

How Is the Trial Designed?

Group I: determine if faster diagnosis to debridement times negate the need for hyperbaric oxygen treatments Experimental Treatment 1 Intervention

Secondary objectives will be to evaluate the morbidity of patients treated with standard of care including hyperbaric oxygen treatments as compared to historical controls. Morbidity metrics include: decreased need for OR debridement, improved quality of life (QOL) scores, reduced mortality, reduced complications, reduced hospital length of stay.

Group II: Will the hyperbaric oxygen improve morbidity and mortality compared to standard of care Experimental Treatment 1 Intervention

We hypothesize the addition of hyperbaric oxygen in conjunction with standard care will improve patient mortality in necrotizing soft tissue infections. This study will evaluate if the addition ofhyperbaric oxygen improves mortality in patients with necrotizing fasciitis and necrotizing soft tissue infections.

Who Is Running the Clinical Trial?

Spectrum Health Hospitals

Lead Sponsor

Trials

66

Recruited

553,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10040118/

The effect of hyperbaric oxygen therapy on the clinical ... The effect of hyperbaric oxygen therapy on the clinical outcomes of necrotizing soft tissue infections: a systematic review and meta-analysis.

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/397749

Hyperbaric Oxygen Treatment and Survival From ... Hyperbaric oxygen therapy was associated with improved survival and limb salvage and should be considered in the setting of NSTI.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07170020

Hyperbaric Oxygen Treatment for Necrotizing Fasciitis and ... This study will evaluate if the addition ofhyperbaric oxygen improves mortality in patients with necrotizing fasciitis and necrotizing soft ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0300738

Contemporary national outcomes of hyperbaric oxygen ... HBOT was associated with decreased mortality, amputations, and non-home discharges in NSTI with the tradeoff of increase to costs and length of stay.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40094581/

Hyperbaric Oxygen Therapy for Necrotizing Soft Tissue ... This retrospective cohort examines the impact of HBOT on clinical outcomes from NSTI at a single center where evaluation for HBOT is standard of care. Methods: ...

6. link.springer.com link.springer.com/article/10.1007/s40121-025-01184-5

Use of Hyperbaric Oxygen in Patients with Necrotizing Soft ... Several observational studies have suggested an association between hyperbaric oxygen (HBO2) treatment and improved survival in patients with ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480412002065

Hyperbaric oxygen therapy in necrotizing soft tissue ... Hyperbaric oxygen therapy does not appear to decrease in-hospital mortality or amputation rate after in patients with NSTI.

8. wjes.biomedcentral.com wjes.biomedcentral.com/articles/10.1186/s13017-022-00448-6

Outcome of necrotizing fasciitis and Fournier's gangrene with ... These results point to a benefit from HBOT for treatment of NSTI in critically ill patients. Background. Necrotizing soft tissue infections ( ...