Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 7:14 AM
Study NCT ID:
NCT01340534
Status:
COMPLETED
Last Update Posted:
2015-01-05
First Post:
2011-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010102', 'term': 'Oxygen Inhalation Therapy'}], 'ancestors': [{'id': 'D012138', 'term': 'Respiratory Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 370}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-01', 'studyFirstSubmitDate': '2011-04-14', 'studyFirstSubmitQcDate': '2011-04-20', 'lastUpdatePostDateStruct': {'date': '2015-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with surgical site infection (SSI).', 'timeFrame': '2 months', 'description': 'The patients will be evaluated for evidence of surgical site infection before leaving the hospital, at 15 and 30 days post surgery. The presence of fever, supurative secretion through the wound or cutaneous changes compatible witn infection will be considered a surgical site infection (SSI). This outcome will be evaluated with a qualitative variable (presence of SSI). The patients will be clasiffied in accordance as "With SSI" or "Without SSI". This will allow us to determine if the use of oxygen at 80% FIO2 can reduce the incidence of SSI.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with respiratory complications trans or post surgery.', 'timeFrame': '2 months', 'description': 'Every patient will be evaluated during surgery and before leaving the hospital for signs of a respiratory complication (persistent cough, fever, dyspnea, atelectatic rales, wheezing). The presence of any of these signs will be used to classify the patients with a qualitative variable ("With Respiratory Complications" or "Without Respiratory Complications") and allow us to determine if the use of oxygen at 80% FIO2 is associated with more respiratory complications.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Surgical wound infection', 'Oxygen', 'Cesarean'], 'conditions': ['Surgical Wound Infection']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Bleixen Admadé and Osvaldo Reyes, "Supplemental Perioperative Oxygen (80% FIO2) for the Prevention of Surgical Site Infection after Emergency Cesarean Section," ISRN Infectious Diseases, vol. 2013, Article ID 526163, 4 pages, 2013. doi:10.5402/2013/526163'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the use of supplemental oxygen at 80% FIO2 can reduce the incidence of surgical site infection after emergency cesarean section.', 'detailedDescription': 'Surgical site infection (SSI) is one of the most important complications that can develop after a cesarean section. SSI can be mild or it can develop into septic shock and death, being cesarean section the most important cause of puerperal infections. Supplemental oxygen at high doses has been advocated as a protective factor for SSI. The purpose of this study is to determine if the use of oxygen at high doses (80% FIO2)can reduce the incidence of SSI after emergency cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age \\> 37 weeks\n* Emergency cesarean section\n* Regional Anesthesia\n\nExclusion Criteria:\n\n* Elective cesarean section\n* Fever of unknown origin at admission\n* Twin pregnancy\n* Chorioamnionitis\n* Acute fetal distress that requires general anesthesia\n* Immunocompromise\n* Maternal Lung/Respiratory Disease'}, 'identificationModule': {'nctId': 'NCT01340534', 'briefTitle': 'Supplemental Perioperative Oxygen to Reduce the Incidence of Post-cesarean Wound Infection', 'organization': {'class': 'OTHER', 'fullName': 'Saint Thomas Hospital, Panama'}, 'officialTitle': 'Supplemental Perioperative Oxygen at 80% FIO2 to Reduce the Incidence of Post-cesarean Wound Infection. A Randomised, Clinical Trial', 'orgStudyIdInfo': {'id': 'MHST2011-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxygen 80% FIO2', 'description': 'Group of 181 patients that will receive supplemental oxygen 80% FIO2 during surgery (cesarean) and two hours after the procedure.', 'interventionNames': ['Device: Supplemental oxygen 80% FIO2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Use of air (no oxygen during surgery)', 'description': 'Group of 181 patients that will not receive supplemental oxygen during surgery (cesarean).', 'interventionNames': ['Procedure: Use of air (no oxygen during surgery)']}], 'interventions': [{'name': 'Supplemental oxygen 80% FIO2', 'type': 'DEVICE', 'otherNames': ['High dose oxygen'], 'description': 'Use of oxygen 80% FIO2 during surgery and 2 hours after the procedure. For this purpose an oxygen mask with reservoir will be used (to guarantee the supply of 80% oxygen during and after surgery)', 'armGroupLabels': ['Oxygen 80% FIO2']}, {'name': 'Use of air (no oxygen during surgery)', 'type': 'PROCEDURE', 'otherNames': ['No oxygen'], 'description': 'No use of oxygen during surgery or in the 2 hours after the procedure.', 'armGroupLabels': ['Use of air (no oxygen during surgery)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panama City', 'state': 'Provincia de Panamá', 'country': 'Panama', 'facility': 'Saint Thomas Maternity Hospital', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}], 'overallOfficials': [{'name': 'Bleixen Admadé, Resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Thomas Maternity Hospital'}, {'name': 'Osvaldo A Reyes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Thomas Maternity Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint Thomas Hospital, Panama', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinator of Development and Research', 'investigatorFullName': 'Osvaldo A. Reyes T.', 'investigatorAffiliation': 'Saint Thomas Hospital, Panama'}}}}