Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-03-02 @ 3:40 PM
Study NCT ID:
NCT03120806
Status:
COMPLETED
Last Update Posted:
2021-12-23
First Post:
2017-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interrupted Versus Continuous Subcuticular Skin Suturing in Elective Cesarean Section.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-12', 'studyFirstSubmitDate': '2017-04-16', 'studyFirstSubmitQcDate': '2017-04-16', 'lastUpdatePostDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'wound infection', 'timeFrame': '10 days after surgery', 'description': 'occurrence of signs of wound infection'}], 'secondaryOutcomes': [{'measure': 'scar dehiscence', 'timeFrame': '10 days after surgery', 'description': 'occurrence of scar dehiscence or incisional hernia'}, {'measure': 'wound seroma', 'timeFrame': '10 days after surgery', 'description': 'occurrence of seroma of wound'}, {'measure': 'the need for reclosure', 'timeFrame': '10 days after surgery', 'description': 'actual gapping of wound'}, {'measure': 'postoperative pain', 'timeFrame': '12 hours after surgery', 'description': 'through visual analogue score The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.'}, {'measure': 'wound hematoma', 'timeFrame': '10 days after surgery', 'description': 'occurrence of subcutanous hematoma'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section Wound']}, 'descriptionModule': {'briefSummary': 'Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group I included women who has their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group II included women who has their skin closed with subcuticular continous suture using the same suture material', 'detailedDescription': 'Non-diabetic pregnant women who undergo elective CS will be randomized into two groups: group I included women who had their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group II included women who had their skin closed with subcuticular continous suture using the same suture material.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '19 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Overall good health\n* Elective Cesarean section ASA class 1 or 2\n\nExclusion Criteria:\n\n* Allergy to synthetic suture materials\n* Diabetes whether gestational or pregestational\n* use of steroid or immunosuppresive medication within last 6 month of procedure\n* Skin sepsis or systemic fever\n* BMI \\> 35\n* History of keloid or hypertrophic scar formation or dermatologic conditions known to impair wound healing ASA class 3 or 4'}, 'identificationModule': {'nctId': 'NCT03120806', 'briefTitle': 'Interrupted Versus Continuous Subcuticular Skin Suturing in Elective Cesarean Section.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Study Between Interrupted and Continuous Subcuticular Skin Suturing in Women Undergoing Elective Cesarean Section. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '167'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'continous subcuticular', 'description': 'skin closed with continous subcuticular mattress suture using non-absorbable polypropylene', 'interventionNames': ['Procedure: continuous subcuticular skin closure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interrupted subcuticular', 'description': 'skin closed with interrupted subcuticular mattress suture using non-absorbable polypropylene', 'interventionNames': ['Procedure: Interrupted subcuticular skin closure']}], 'interventions': [{'name': 'Interrupted subcuticular skin closure', 'type': 'PROCEDURE', 'description': 'skin is closed with interrupted mattress subcuticular sutures using non-absorbable polypropylene after elective cesarean section', 'armGroupLabels': ['Interrupted subcuticular']}, {'name': 'continuous subcuticular skin closure', 'type': 'PROCEDURE', 'description': 'skin is closed with continuous subcuticular sutures using non-absorbable polypropylene after elective cesarean section', 'armGroupLabels': ['continous subcuticular']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12151', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed Maged, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasr Alainy medical school'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ahmed M Maged, MD', 'investigatorAffiliation': 'Cairo University'}}}}