Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-06-26 @ 4:05 AM
Study NCT ID:
NCT02839005
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
2016-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Absorbable Suture Versus Nonabsorbable Suture Intradermal for the Skin Transverse Section in Cesarean
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C095495', 'term': 'glycolide E-caprolactone copolymer'}, {'id': 'D009757', 'term': 'Nylons'}], 'ancestors': [{'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-07-18', 'studyFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2016-07-18', 'lastUpdatePostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Photographic documentation for evaluation', 'timeFrame': '6 Months', 'description': 'The photographic record was sent to three experts for evaluation of hypertrophy and cross marks staining points, according Trimboset al.,1993'}, {'measure': 'Photographic documentation for evaluation', 'timeFrame': '6 Months', 'description': 'The photographic record was sent to another expert for evaluation of hypertrophy and cross marks staining points, according Trimboset al.,1993, besides scar mesure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Wound Closure Thechnical', 'Wound Healing'], 'conditions': ['Cesarean Section', 'Sutures']}, 'descriptionModule': {'briefSummary': 'Context: Cesarean section is the most common surgery in women, both in developed and underdeveloped countries. However results are conflicting report in which material for intradermal suturing get better aesthetic result. Objective: To compare the aesthetic appearance of two suture materials, polyglecaprone 25 and polyamide (nylon) with intradermal sutures for skin closure in women undergoing cesarean section first. Methods: This is a clinical, prospective and randomized study which was conducted in the Department of Gynecology and Obstetrics of a tertiary Institute, Hospital das Clinicas Samuel Libânio, in PousoAlegre, Estate of Minas Gerais. Sixty women undergoing cesarean section were first included and randomized into two groups: group I (n = 30) polyamide and group II (n = 30) polyglecaprone 25. Hypertrophy, color and width of the wound were evaluated, receiving a score, according to Trimbos table, six months after surgery. Later the results were compared to non-parametric statistical tests'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent cesarean section\n* No restriction of ethnicity, education or social class\n\nExclusion Criteria:\n\n* Scarring Pfannenstiel prior\n* Diabetic patients using drugs;\n* Patients with collagen diseases\n* Patients with pre operative tests to indicate any systemic sign of infection or site, not previously treated until the time of surgery.\n* Patients who withdrew informed consent\n* Patients who did not attend the pre scheduled dates for the controls after surgery .'}, 'identificationModule': {'nctId': 'NCT02839005', 'briefTitle': 'Absorbable Suture Versus Nonabsorbable Suture Intradermal for the Skin Transverse Section in Cesarean', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Vale do Sapucai'}, 'orgStudyIdInfo': {'id': 'MRJ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'suture with polyglecaprone 25', 'interventionNames': ['Other: Continuous suture with polyglecaprone 25']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'suture with polyamide (nylon)', 'interventionNames': ['Other: Continuous suture with polyamide (nylon)']}], 'interventions': [{'name': 'Continuous suture with polyglecaprone 25', 'type': 'OTHER', 'description': 'At the end of surgical procedemento of cesarean delivery , for skin closure continuous suture was performed with polyglecaprone 25', 'armGroupLabels': ['suture with polyglecaprone 25']}, {'name': 'Continuous suture with polyamide (nylon)', 'type': 'OTHER', 'description': 'At the end of surgical procedemento of cesarean delivery , for skin closure continuous suture was performed with polyamide (nylon)', 'armGroupLabels': ['suture with polyamide (nylon)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37550-000', 'city': 'Pouso Alegre', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital das Clínicas Samuel Libânio', 'geoPoint': {'lat': -22.23, 'lon': -45.93639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Vale do Sapucai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Roberta Junqueira Lima', 'investigatorAffiliation': 'Universidade do Vale do Sapucai'}}}}