Hyperbaric Oxygen Treatment for Necrotizing Fasciitis and Necrotizing Soft Tissue Infections

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Corewell Health West
Study ID
NCT07170020
Status
Not Yet Recruiting

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Conditions

  • Necrotizing Fascitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Nov 14, 2025
Status verified
Sep 2025
Primary completion
Nov 14, 2026
Completion
Nov 14, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Mortality improvement [ Time Frame: 6 months post procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Corewell HealthGrand RapidsMichigan49503
Kendra Selby
[email protected]
2694912506
Drue Orwig (PRINCIPAL_INVESTIGATOR)
John McGlynn (SUB_INVESTIGATOR)
Elizabeth Steensma (SUB_INVESTIGATOR)

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By research site
Corewell Health· Grand Rapids, MI

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