Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT00876005
Status:
COMPLETED
Last Update Posted:
2016-10-13
First Post:
2009-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Supplemental Oxygen and the Risk of Surgical Site Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2009-04-03', 'studyFirstSubmitQcDate': '2009-04-03', 'lastUpdatePostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical site infection', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Wound infection'], 'conditions': ['Surgical Site Infection']}, 'referencesModule': {'references': [{'pmid': '23743467', 'type': 'DERIVED', 'citation': 'Duggal N, Poddatorri V, Noroozkhani S, Siddik-Ahmad RI, Caughey AB. Perioperative oxygen supplementation and surgical site infection after cesarean delivery: a randomized trial. Obstet Gynecol. 2013 Jul;122(1):79-84. doi: 10.1097/AOG.0b013e318297ec6c.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to see whether increasing the oxygen concentration during and after a cesarean section decreases the infection rate.', 'detailedDescription': 'This is a double-blinded prospective randomized,controlled trial to evaluate whether using a higher concentration of oxygen during and after surgery helps to decrease the wound infection rate in patients undergoing cesarean sections.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mentally competent patients undergoing cesarean section under spinal or epidural anesthesia\n\nExclusion Criteria:\n\n* fever/chorioamnionitis; GBS positive on antibiotics; immunocompromised / HIV patients; on antibiotics for any reason; general anesthesia; age less than 18 years custody patients stat cesarean section'}, 'identificationModule': {'nctId': 'NCT00876005', 'acronym': 'PORSSI', 'briefTitle': 'Supplemental Oxygen and the Risk of Surgical Site Infection', 'organization': {'class': 'OTHER', 'fullName': 'Santa Clara Valley Health & Hospital System'}, 'officialTitle': 'Perioperative Supplemental Oxygen and the Risk of Surgical Site Infection', 'orgStudyIdInfo': {'id': '5/11/07-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '80% oxygen during cesarean section', 'interventionNames': ['Other: Oxygen by mask']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '30% oxygen during cesarean section', 'interventionNames': ['Other: Oxygen by mask']}], 'interventions': [{'name': 'Oxygen by mask', 'type': 'OTHER', 'otherNames': ['Face mask delivery of supplemental oxygen at 80%'], 'description': 'Postoperatively, an aerosol face mask is used to deliver oxygen at 80%', 'armGroupLabels': ['1']}, {'name': 'Oxygen by mask', 'type': 'OTHER', 'otherNames': ['face mask delivery of supplemental oxygen at 30%'], 'description': 'Postoperatively, an aerosol face mask is used to deliver oxygen at 30%', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95128', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Santa clara Valley Medical Center', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}], 'overallOfficials': [{'name': 'Neena Duggal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Santa Clara Valley Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santa Clara Valley Health & Hospital System', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Neena Duggal, MD', 'oldOrganization': 'Santa Clara Valley Medical Center'}}}}