Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-04-15 @ 3:41 PM
Study NCT ID:
NCT01739959
Status:
COMPLETED
Last Update Posted:
2012-12-04
First Post:
2012-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study of Raised Serum Lactate as a Marker of Necrotizing Fasciitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019115', 'term': 'Fasciitis, Necrotizing'}, {'id': 'D018934', 'term': 'Fournier Gangrene'}, {'id': 'D002481', 'term': 'Cellulitis'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-28', 'studyFirstSubmitDate': '2012-11-26', 'studyFirstSubmitQcDate': '2012-11-28', 'lastUpdatePostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum lactate level', 'timeFrame': 'At referral to the Plastic Surgery Team', 'description': 'Serum lactate level at initial referral to the plastic surgery team, as measured by arterial blood gas analysis (calibrated point-of-care testing). Levels compared between the group with confirmed histological necrosis at initial surgical debridement, versus those with no evidence of necrosis (a composite of those who did not undergo surgery as they were judged not to have necrotizing fasciitis, and those who did undergo surgery, but whose histology did not show tissue necrosis).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Necrotizing fasciitis', "Fournier's gangrene", 'Cellulitis', 'Serum Lactate'], 'conditions': ['Fasciitis, Necrotizing']}, 'descriptionModule': {'briefSummary': 'The investigators examined the hypothesis that serum lactate is raised in early necrotizing fasciitis to a much greater extent than in other differential diagnoses, such as severe cellulitis, and therefore provides a diagnostic indicator.', 'detailedDescription': "A prospective comparison of serum lactate levels at referral to the Plastic Surgery team to the 'gold standard' test of histology at initial surgical debridement, looking at 53 consecutive patients referred with suspected necrotizing fasciitis to a single surgeon at one institution between 2000 and 2010."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients referred to a single surgeon at one institution over 10 years (September 2000 - September 2010) with a suspected diagnosis of necrotizing fasciitis. Patients were followed for the duration of their hospital stay.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referral to one consultant (Mr A Armstrong) at one institution (Wexham Park Hospital) with a suspected diagnosis of necrotizing fasciitis between September 2000 and September 2010\n\nExclusion Criteria:\n\n* Nil'}, 'identificationModule': {'nctId': 'NCT01739959', 'briefTitle': 'Exploratory Study of Raised Serum Lactate as a Marker of Necrotizing Fasciitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Health Service, United Kingdom'}, 'officialTitle': 'Raised Serum Lactate as a Marker of Necrotizing Fasciitis; a Consecutive Prospective Review.', 'orgStudyIdInfo': {'id': 'WPH/NF/2000-2010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Necrotizing fasciitis proven', 'description': 'Histological evidence of necrotizing fasciitis at initial surgical debridement'}, {'label': 'Not necrotizing fasciitis', 'description': 'A composite of those with no histological tissue necrosis at initial surgical debridement, and those clinically judged not to be a necrotizing infection who therefore did not undergo surgery.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SL2 4HL', 'city': 'Slough', 'state': 'London', 'country': 'United Kingdom', 'facility': 'Wexham Park Hospital', 'geoPoint': {'lat': 51.50949, 'lon': -0.59541}}], 'overallOfficials': [{'name': 'George Murphy, MRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wexham Park Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Health Service, United Kingdom', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'George Murphy', 'investigatorAffiliation': 'National Health Service, United Kingdom'}}}}