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NCT Number: NCT07170020

Hyperbaric Oxygen Treatment for Necrotizing Fasciitis and Necrotizing Soft Tissue Infections

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corewell Health

Grand Rapids, Michigan, 49503, United States

Location contact

Drue Orwig

PRINCIPAL_INVESTIGATOR

Elizabeth Steensma

SUB_INVESTIGATOR

John McGlynn

SUB_INVESTIGATOR

Kendra Selby

CONTACT

[email protected]

2694912506

About this study

Necrotizing fasciitis and necrotizing soft tissue infections are a complicated group of infections dominated largely by polymicrobial infections that rapidly spread through the skin and soft tissues. Secondary effects include vascular occlusion, ischemia, tissue necrosis, along with sepsis and multi-organ involvement. The incidence of necrotizing infections is about 6500 cases annually in the US2. There have been no major advances in disease management over the past twenty years and the mortality still ranges in the 10-43 % range2. Today early aggressive debridement and IV antibiotics remain the cornerstone of treatment. Hyperbaric oxygen has been shown in several case studies and retrospective studies to possibly improve mortality and morbidity in this patient population.1-4 One limitation of prior studies is many of them are retrospective. Additionally, not all centers are able to take patients quickly back for surgical debridement which could increase rates of morbidity and mortality. Corewell Health West Butterworth Hospital has 24/7 in-hospital acute care surgery services. This allows very short diagnosis to OR debridement wait times in necrotizing infections. This study therefore has two aims: first is to determine if hyperbaric oxygen improve morbidity and mortality compared to standard of care using a prospective model. Secondly, to determine if faster diagnosis to debridement times negate the need for hyperbaric oxygen treatments in necrotizing infections.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Pediatric patients
  • Pregnant patients
  • Patients deemed unlikely to survive or unable to go to surgical debridement

Treatment and study plan

Hyperbaric Oxygen Therapy

Procedure

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.

Primary outcomes

  1. Mortality improvement

    Time frame: 6 months post procedure

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

Secondary outcomes

  1. Morbitity

    Time frame: 6 months post procedure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Drue Orwig

CONTACT

[email protected]

616-391-5272

Kendra Selby

CONTACT

[email protected]

616-486-0281

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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