Hyperbaric Oxygen Treatment for Necrotizing Fasciitis and Necrotizing Soft Tissue Infections

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorewell Health West

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Hyperbaric Oxygen Therapy

    Procedure/Surgery

    Hyperbaric 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

160 Participants
are divided into 2 treatment groups
Group A: Will the hyperbaric oxygen improve morbidity and mortality compared to standard of careExperimental treatment 1 intervention
Group B: determine if faster diagnosis to debridement times negate the need for hyperbaric oxygen treatmentsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mortality improvement

To evaluate if the addition of hyperbaric oxygen improves mortality in patients with necrotizing fasciitis and necrotizing soft tissue infections.

Time frame
6 months post procedure

Secondary outcomes

1

Morbitity

To evaluate the morbidity of patients treated with standard of care including hyperbaric oxygen treatments as compared to historical controls.

Time frame
6 months post procedure

Other outcomes

Sponsors and contacts

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