Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT07170020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hyperbaric Oxygen Treatment for Necrotizing Fasciitis and Necrotizing Soft Tissue Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019115', 'term': 'Fasciitis, Necrotizing'}, {'id': 'D005208', 'term': 'Fasciitis'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006931', 'term': 'Hyperbaric Oxygenation'}], 'ancestors': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-11-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-09-10', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality improvement', 'timeFrame': '6 months post procedure', 'description': 'To evaluate if the addition of hyperbaric oxygen improves mortality in patients with necrotizing fasciitis and necrotizing soft tissue infections.'}], 'secondaryOutcomes': [{'measure': 'Morbitity', 'timeFrame': '6 months post procedure', 'description': 'To evaluate the morbidity of patients treated with standard of care including hyperbaric oxygen treatments as compared to historical controls.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['necrotizing', 'fascitis', 'hyperbaric'], 'conditions': ['Necrotizing Fascitis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07170020', 'briefTitle': 'Hyperbaric Oxygen Treatment for Necrotizing Fasciitis and Necrotizing Soft Tissue Infections', 'organization': {'class': 'OTHER', 'fullName': 'Corewell Health West'}, 'officialTitle': 'Hyperbaric Oxygen Treatment for Necrotizing Fasciitis and Necrotizing Soft Tissue Infections', 'orgStudyIdInfo': {'id': '2025-0980'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Will the hyperbaric oxygen improve morbidity and mortality compared to standard of care', 'description': '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.', 'interventionNames': ['Procedure: Hyperbaric Oxygen Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'determine if faster diagnosis to debridement times negate the need for hyperbaric oxygen treatments', 'description': '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.', 'interventionNames': ['Procedure: Hyperbaric Oxygen Therapy']}], 'interventions': [{'name': 'Hyperbaric Oxygen Therapy', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'contacts': [{'name': 'Kendra Selby', 'role': 'CONTACT', 'email': 'kendra.selby@helendevoschildrens.org', 'phone': '2694912506'}, {'name': 'Drue Orwig', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'John McGlynn', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elizabeth Steensma', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Corewell Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}], 'centralContacts': [{'name': 'Kendra Selby', 'role': 'CONTACT', 'email': 'kendra.selby@helendevoschildrens.org', 'phone': '616-486-0281'}, {'name': 'Drue Orwig', 'role': 'CONTACT', 'email': 'Drue.Orwig@corewellhealth.org', 'phone': '616-391-5272'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corewell Health West', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Section Chief, Hyperbaric/Wound Care', 'investigatorFullName': 'Drue Orwig', 'investigatorAffiliation': 'Corewell Health West'}}}}