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
NCT Number: NCT07170020
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Grand Rapids, Michigan, 49503, United States
Drue Orwig
PRINCIPAL_INVESTIGATOR
Elizabeth Steensma
SUB_INVESTIGATOR
John McGlynn
SUB_INVESTIGATOR
Kendra Selby
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Drue Orwig
CONTACT
Kendra Selby
CONTACT
Corewell Health West
Other
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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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