Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-02-23 @ 3:06 AM
Study NCT ID:
NCT02762357
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2016-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PMCF-study Using Novosyn® Quick Suture Material for Perineal Repair After Episiotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2016-05-03', 'studyFirstSubmitQcDate': '2016-05-03', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of wound dehiscence', 'timeFrame': '3 months postpartum', 'description': 'A dehiscence of the skin which needs surgical treatment with re-closure.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Re-suturing', 'timeFrame': '3 months postpartum', 'description': 'Re-suturing due to wound dehiscence'}, {'measure': 'Incidence of suture removal', 'timeFrame': '3 months postpartum', 'description': 'Suture removal due to wound problems (infection, gaping wound, residual material requiring removal)'}, {'measure': 'Short-term perineal pain (VAS)', 'timeFrame': '24h to 48h, 10 days postpartum'}, {'measure': 'Long term perineal pain (VAS)', 'timeFrame': '3 months postpartum'}, {'measure': 'Pain in daily living (VAS)', 'timeFrame': '24h and 10 days postpartum', 'description': 'Pain in repose, during walking, during sitting, when urinating, and when defecating'}, {'measure': 'Dyspareunia', 'timeFrame': '3 months post-operatively', 'description': 'Questionnaire'}, {'measure': 'Sexual intercourse', 'timeFrame': '3 months post-operatively', 'description': 'Questionnaire'}, {'measure': 'Patient satisfaction with the repair (VAS)', 'timeFrame': 'until 3 months postpartum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Novosyn Quick', 'Episiotomy'], 'conditions': ['Episiotomy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for episiotomy. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature. Study population consists of women with a spontaneous vaginal delivery who required perineal repair due to an episiotomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primiparous women who require perineal repair due to an episiotomy after spontaneous vaginal delivery.\n* Singleton birth between 37 and 42 weeks gestation\n* Written informed consent\n\nExclusion Criteria:\n\n* Age\\< 18 years\n* Previous perineal surgery\n* Instrumental vaginal deliveries\n* Multiparous (at least 1 previous perineal delivery)\n* Episiotomy involving the anal sphincter or the rectum\n* Medical consumption that might adversely affect healing\n* Women with active infection at the time of delivery'}, 'identificationModule': {'nctId': 'NCT02762357', 'acronym': 'EPINOQ', 'briefTitle': 'PMCF-study Using Novosyn® Quick Suture Material for Perineal Repair After Episiotomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Post-Marketing Clinical Follow-up (PMCF) Study to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material for Episiotomy . A Monocenter, Prospective, Observational Study.', 'orgStudyIdInfo': {'id': 'AAG-O-H-1504'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Novosyn® Quick', 'description': 'episiotomy closure using suture material', 'interventionNames': ['Device: Novosyn® Quick']}], 'interventions': [{'name': 'Novosyn® Quick', 'type': 'DEVICE', 'description': 'Episiotomy closure', 'armGroupLabels': ['Novosyn® Quick']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08402', 'city': 'Granollers', 'country': 'Spain', 'facility': 'Hospital General de Granollers', 'geoPoint': {'lat': 41.60797, 'lon': 2.28773}}, {'zip': '08190', 'city': 'Sant Cugat Del Vallés', 'country': 'Spain', 'facility': 'IDC Hospital General de Catalunya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'B.Braun Surgical SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}