Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT04006067
Status:
UNKNOWN
Last Update Posted:
2020-03-10
First Post:
2019-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2019-06-29', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of any post cesarean wound related complication', 'timeFrame': '8 weeks', 'description': 'including wound hematoma, seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Decreasing Wound Infection']}, 'descriptionModule': {'briefSummary': 'The investigators aim to compare the effect of changing their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure versus no intervention in the incidence of postoperative wound infections in pregnant women undergoing Caesarean section. The primary outcome is the incidence of any post cesarean wound related complication, including wound seroma, skin separation of at least 1cm, wound infection, or other incisional abnormality requiring treatment within 8 weeks of surgery, while the secondary outcomes are Postoperative fever: defined as greater than 38 degrees Celsius or post cesarean endometritis: defined as a clinical diagnosis, usually involving fever, uterine fundal tenderness, or purulent lochia requiring antibiotic therapy or Combined wound complications and endometritis.', 'detailedDescription': 'The investigators conduct a prospective randomized study at Department of Obstetrics and Gynecology, AFHSR since April 2019 till October 2019, after approval of the study protocol by the Local Ethical Committee.\n\nPatients undergoing Both elective and emergency cesarean sections and Patients received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case. All patients received appropriate pre-operative antibiotics, chlorohexidine skin prep except where allergies prohibited, and hair clipping as indicated.\n\nThe patients (600) are divided into two groups, Group A (300) during CS the surgical team change their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure, while in Group B (300) no intervention'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Both elective and emergency cesarean sections.\n2. Patient received standard antibiotic prophylaxis within two hours from the procedure or during the procedure in emergency case.\n\nExclusion Criteria:\n\n1. Women with active infection during the procedure.\n2. Women did not receive the standard preoperative antibiotic prophylaxis.\n3. Women with diagnosis of chorioamnionitis.'}, 'identificationModule': {'nctId': 'NCT04006067', 'briefTitle': 'The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'The Impact of Changing Gloves During Cesarean Section on Post-operative Wound Complication. A Single Blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'khalid-shafik'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'interventionNames': ['Other: changing surgical gloves']}, {'type': 'NO_INTERVENTION', 'label': 'Group B'}], 'interventions': [{'name': 'changing surgical gloves', 'type': 'OTHER', 'description': 'All the surgical team including surgeons, surgical assists and scrub technicians replaced their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure.', 'armGroupLabels': ['Group A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Khamis Mushait', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Khalid ibrahim, MD', 'role': 'CONTACT', 'phone': '00966596984055'}, {'name': 'mohamed hussein, MD', 'role': 'CONTACT', 'phone': '00966596984055'}], 'facility': 'AFHSR', 'geoPoint': {'lat': 18.3, 'lon': 42.73333}}], 'centralContacts': [{'name': 'Khalid ibrahim, MD', 'role': 'CONTACT', 'email': 'dr.khalidkhader77@yahoo.com', 'phone': '00966596984055'}, {'name': 'ahmed morsi, MD', 'role': 'CONTACT', 'phone': '00966596984055'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'will be shared later on'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'khalid abd aziz mohamed', 'class': 'OTHER'}, 'collaborators': [{'name': 'Armed Forces Hospitals, Southern Region, Saudi Arabia', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'khalid abd aziz mohamed', 'investigatorAffiliation': 'Benha University'}}}}