Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-30 @ 4:05 PM
Study NCT ID:
NCT00873704
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2009-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supplemental Oxygen in Vascular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 274}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-11', 'studyFirstSubmitDate': '2009-03-31', 'studyFirstSubmitQcDate': '2009-03-31', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgical wound infection', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Surgical Wound Infection', 'Vascular Surgery']}, 'referencesModule': {'references': [{'pmid': '41159585', 'type': 'DERIVED', 'citation': 'Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2.'}, {'pmid': '21476113', 'type': 'DERIVED', 'citation': 'Turtiainen J, Saimanen EI, Partio TJ, Makinen KT, Reinikainen MT, Virkkunen JJ, Vuorio KS, Hakala T. Supplemental postoperative oxygen in the prevention of surgical wound infection after lower limb vascular surgery: a randomized controlled trial. World J Surg. 2011 Jun;35(6):1387-95. doi: 10.1007/s00268-011-1090-y.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to test the hypothesis that supplemental postoperative oxygen reduces the risk of surgical wound infection in patients following lower limb vascular surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* lower limb vascular surgery\n\nExclusion Criteria:\n\n* COPD\n* sPO2 less than 90%'}, 'identificationModule': {'nctId': 'NCT00873704', 'briefTitle': 'Supplemental Oxygen in Vascular Surgery', 'organization': {'class': 'OTHER', 'fullName': 'North Karelia Central Hospital'}, 'officialTitle': 'Supplemental Postoperative Oxygen and the Risk of Surgical Wound Infection in a Vascular Surgery Population: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NKCH-Surg-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'recieves supplemental oxygen postoperatively', 'interventionNames': ['Other: supplemental postoperative oxygen']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'treated as usual without supplemental oxygen'}], 'interventions': [{'name': 'supplemental postoperative oxygen', 'type': 'OTHER', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80210', 'city': 'Joensuu', 'country': 'Finland', 'facility': 'North Karelia Central Hospital', 'geoPoint': {'lat': 62.60118, 'lon': 29.76316}}, {'zip': '40620', 'city': 'Jyväskylä', 'country': 'Finland', 'facility': 'Central Finland Central Hospital', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}, {'zip': '53130', 'city': 'Lappeenranta', 'country': 'Finland', 'facility': 'South Karelia Central Hospital', 'geoPoint': {'lat': 61.05871, 'lon': 28.18871}}, {'zip': '50100', 'city': 'Mikkeli', 'country': 'Finland', 'facility': 'Central Hospital of Mikkeli', 'geoPoint': {'lat': 61.68857, 'lon': 27.27227}}, {'zip': '96101', 'city': 'Rovaniemi', 'country': 'Finland', 'facility': 'Lapland Central Hospital', 'geoPoint': {'lat': 66.49897, 'lon': 25.68867}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Karelia Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sanna Kouhia', 'investigatorAffiliation': 'North Karelia Central Hospital'}}}}