Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT03702751
Status:
COMPLETED
Last Update Posted:
2022-01-03
First Post:
2018-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Steristrips Adhesive Tape Versus Subcuticular Suture for Episiotomy Repair in Primigravid Obese Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D053832', 'term': 'Surgical Tape'}], 'ancestors': [{'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-13', 'studyFirstSubmitDate': '2018-10-06', 'studyFirstSubmitQcDate': '2018-10-09', 'lastUpdatePostDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of pain 6h postoperatively', 'timeFrame': '6 hours after the procedure', 'description': 'the patient will report her pain by placing a line perpendicular to the VAS line at the point that represents their pain intensity.VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain.'}, {'measure': 'Severity of pain 12 hours postpartum', 'timeFrame': '12 hours after the procedure', 'description': 'the patient will report her pain by placing a line perpendicular to the VAS line at the point that represents their pain intensity. VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain.'}], 'secondaryOutcomes': [{'measure': 'wound healing', 'timeFrame': '7-10 days after delivery', 'description': 'During the second visit 7-10 days after delivery; wound healing will be evaluated and recorded by Redness, Edema, Ecchymosis, Drainage, Approximation (REEDA), data may be collected by home visits for those may not be able to come back for the second visit.'}, {'measure': 'Severity of pain 10 days postpartum', 'timeFrame': '10 days after procedure', 'description': 'pain experience will be evaluated by visual analog scale'}, {'measure': 'timing of procedure', 'timeFrame': 'During the procedure', 'description': 'timing of both procedures will be recorded and documented'}, {'measure': 'Severity of pain immediately after episiotomy repair', 'timeFrame': 'immediately after the procedure', 'description': 'pain experience will be evaluated immediately after the procedure by the visual analog scale(VAS). VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Episiotomy Wound']}, 'descriptionModule': {'briefSummary': 'This study will be done to question the superiority of using skin adhesive tape (® Steri-Strip) closure in wound pain and healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy in obese primiparous women..', 'detailedDescription': 'Episiotomy is the most common operating procedure that most obstetricians will perform in their lifetime. Because it is so common and considered minor surgery, teaching students or interns the principles and techniques usually is left to the most junior of residents\n\nThe optimal method for episiotomy and perineal trauma repair following childbirth remains open to debate and a great cause of concern to doctors, midwives, and the public\n\nApparently, the ideal method for perineal repair should be quick, painless, easy to perform and preferably, without an increase in pain and dyspareunia during the puerperium\n\nThis study will be commenced to question the advantage of using skin adhesive tape (® Steri-Strip) closure in wound pain and healing over the traditional running absorbable subcuticular suture technique in perineal repair after episiotomy in obese primiparous women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primigravidae 18 years or older.\n* Spontaneous not induced full term normal not instrumental vaginal delivery with mediolateral episiotomy.\n* First and 2nd-degree perineal tear.\n* BMI≥30\n\nExclusion Criteria:\n\n* • patients who had an instrumental delivery.\n\n * 3rd and fourth-degree perineal tears.\n * those with local infectious lesions in the area to be repaired.\n * preexisting medical disorders as diabetes mellitus, severe pulmonary disease and collagen disease.\n * Immunosuppressive treatment.\n * known hypersensitivity to adhesive tape or materials.\n * Maternal unwillingness to undergo randomization.'}, 'identificationModule': {'nctId': 'NCT03702751', 'briefTitle': 'Steristrips Adhesive Tape Versus Subcuticular Suture for Episiotomy Repair in Primigravid Obese Women', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Study Between Skin Adhesive Steristrips and Subcuticular Suture for Episiotomy Skin Repair in Primigravid Obese Women: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'episiotomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adhesive tape', 'description': 'will be subjected to skin repair after episiotomy with skin adhesive tape.', 'interventionNames': ['Procedure: Adhesive tape']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous subcuticular skin suturing', 'description': 'will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture.', 'interventionNames': ['Procedure: Continuous subcuticular skin suturing']}], 'interventions': [{'name': 'Adhesive tape', 'type': 'PROCEDURE', 'description': 'will be subjected to skin repair after episiotomy with skin adhesive tape.', 'armGroupLabels': ['Adhesive tape']}, {'name': 'Continuous subcuticular skin suturing', 'type': 'PROCEDURE', 'description': 'will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture.', 'armGroupLabels': ['Continuous subcuticular skin suturing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12944', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Ahmed Ashour', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'AHMED SAMY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer in obstetrics and gynecology', 'investigatorFullName': 'Ahmed Samy aly ashour', 'investigatorAffiliation': 'Cairo University'}}}}