About this trial
The goal of this clinical trial is to learn if hyperbaric oxygen is beneficial in treating necrotizing infections and decreasing rates of morbidity and mortality. This study therefore has two aims:
1. Determine if hyperbaric oxygen improve morbidity and mortality compared to standard of care using a prospective model. 2. Determine if faster diagnosis to debridement times negate the need for hyperbaric oxygen treatments in necrotizing infections.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 18 years old
Patients with documented necrotizing fasciitis or necrotizing soft tissue infection as assessed during initial bedside evaluation, in conjunction with available laboratory values, imaging showing gas in soft tissues consitent with necrotizing infection, or surgical debridement of necrosis of fascia, muscle, and variable levels of soft tissue involvement
Patient or advocate is able to sign consent
Disqualifiers
Pediatric patients
Pregnant patients
Patients deemed unlikely to survive or unable to go to surgical debridement
Trial design
Parallel
Treatments tested in this trial
Hyperbaric Oxygen Therapy
Procedure/SurgeryHyperbaric oxygen has been shown in several case studies and retrospective studies to possibly improve mortality and morbidity in this patient population. One limitation of prior studies is many of them are retrospective. This study will be prospective.
Treatment groups
Trial outcomes
Primary outcomes
Mortality improvement
To evaluate if the addition of hyperbaric oxygen improves mortality in patients with necrotizing fasciitis and necrotizing soft tissue infections.
Secondary outcomes
Morbitity
To evaluate the morbidity of patients treated with standard of care including hyperbaric oxygen treatments as compared to historical controls.
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: