Hyperbaric Oxygen Treatment for Necrotizing Fasciitis and Necrotizing Soft Tissue Infections

NCT07170020 | Not Yet Recruiting DMC

• 1 other identifier: 2025-0980
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Determine if hyperbaric oxygen improve morbidity and mortality compared to standard of care using a prospective model.
2. 2.Determine if faster diagnosis to debridement times negate the need for hyperbaric oxygen treatments in necrotizing infections.

Conditions

Necrotizing Fascitis

Keywords

necrotizing; fascitis; hyperbaric

Outcome Measures

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.

  6 months post procedure

Secondary Outcomes (1)

• Morbitity

  6 months post procedure

Study Arms (2)

Will the hyperbaric oxygen improve morbidity and mortality compared to standard of care

EXPERIMENTAL

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.

Procedure: Hyperbaric Oxygen Therapy

determine if faster diagnosis to debridement times negate the need for hyperbaric oxygen treatments

EXPERIMENTAL

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.

Procedure: Hyperbaric Oxygen Therapy

Interventions

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.

Will the hyperbaric oxygen improve morbidity and mortality compared to standard of care; determine if faster diagnosis to debridement times negate the need for hyperbaric oxygen treatments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Corewell Health West: lead

Study Sites (1)

Corewell Health

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Fasciitis, Necrotizing; Fasciitis

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Central Study Contacts

Kendra Selby

CONTACT

616-486-0281; kendra.selby@helendevoschildrens.org

Drue Orwig

CONTACT

616-391-5272; Drue.Orwig@corewellhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Chief, Hyperbaric/Wound Care

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 12, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): November 14, 2026
• Study Completion (Estimated): November 14, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

US (1)