[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606013":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":35,"responsibleParty":59,"collaborators":24,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":24,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":24,"enrollmentInfo":69,"targetDuration":24,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":82,"whyStopped":24,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Corewell Health West","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Procedure: Hyperbaric Oxygen Therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Hyperbaric Oxygen Therapy","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.",[9,15],null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Kendra Selby","CONTACT","616-486-0281","kendra.selby@helendevoschildrens.org",{"name":32,"role":28,"phone":33,"phoneExt":24,"email":34},"Drue Orwig","616-391-5272","Drue.Orwig@corewellhealth.org",[36],{"facility":37,"status":24,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Corewell Health","Grand Rapids","Michigan","49503","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-85.66809,42.96336,{"lat":47,"lon":46},[50,52,54,57],{"name":27,"role":28,"phone":51,"phoneExt":24,"email":30},"2694912506",{"name":32,"role":53,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"name":55,"role":56,"phone":24,"phoneExt":24,"email":24},"John McGlynn","SUB_INVESTIGATOR",{"name":58,"role":56,"phone":24,"phoneExt":24,"email":24},"Elizabeth Steensma",{"type":53,"investigatorFullName":32,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Section Chief, Hyperbaric\u002FWound Care","100606013","hyperbaric-oxygen-treatment-for-necrotizing-fasciitis-and-necrotizing-soft-tissue-infections-100606013",false,"NCT07170020","Hyperbaric Oxygen Treatment for Necrotizing Fasciitis and Necrotizing Soft Tissue Infections","Inclusion Criteria:\n\n* Age: 18 years old\n* 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\n* Patient or advocate is able to sign consent\n\nExclusion Criteria:\n\n* Pediatric patients\n* Pregnant patients\n* Patients deemed unlikely to survive or unable to go to surgical debridement","ALL","18 Years",{"count":70,"type":71},160,"ESTIMATED","INTERVENTIONAL",[74],"NA","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:\n\n1. Determine if hyperbaric oxygen improve morbidity and mortality compared to standard of care using a prospective model.\n2. Determine if faster diagnosis to debridement times negate the need for hyperbaric oxygen treatments in necrotizing infections.",[77],"Necrotizing Fascitis",[79,80,81],"necrotizing","fascitis","hyperbaric","NOT_YET_RECRUITING","2025-09-10",{"date":85,"type":86},"2025-09-12","ACTUAL",{"date":88,"type":71},"2025-11-14",{"date":90,"type":71},"2027-11-14",{"name":5,"class":6},1]