Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT05296902
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2022-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Performance of Safety of SILKAM® Suture Material in Oral Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014095', 'term': 'Tooth, Impacted'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2022-03-16', 'studyFirstSubmitQcDate': '2022-03-16', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Wound Dehiscence rate', 'timeFrame': 'until day of suture removal (approximately 1 week after surgery)', 'description': 'Pathologic process consisting of a partial or complete disruption of the layers of a surgical wound.'}, {'measure': 'Complication rate', 'timeFrame': 'until day of suture removal (approximately 1 week after surgery)', 'description': 'Complications rate according to the "Classification of Askar" as Grade 1 (Localized complication(s) accompanied by no adverse effects on the success of the surgery) and Grade 2 (Localized complication(s) accompanied by adverse effects on the success of the surgery).'}], 'secondaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': 'until day of suture removal (approximately 1 week after surgery)', 'description': 'Complications rate according to the "Classification of Askar" as Grade 3 (Localized or systemic complication(s) that impairs the patient\'s daily routine but does not require hospitalization), Grade 4 (Localized or systemic complication(s) that impairs the patient\'s daily routine and requires hospitalization), Grade 5 (Localized or systemic complication(s) that inflicts irreversible damage to \\>1 anatomical structures), or Grade 6 (Localized or systemic complication(s) that lead to death.'}, {'measure': 'Pain assessment using the visual analogue scale (VAS 1-100)', 'timeFrame': 'until day of suture removal (approximately 1 week after surgery)', 'description': 'This parameter will be noted according to the Patient self assessment using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "maximal pain".'}, {'measure': 'Satisfaction of the patient using the visual analogue scale (VAS 1-100)', 'timeFrame': 'until day of suture removal (approximately 1 week after surgery)', 'description': 'This parameter will be noted according to the Patient self assessment using the Visual Analogue Scale (VAS) which state "0" at one end representing "completely satisfied" and "100" at the opposite end representing "not at all satisfied".'}, {'measure': 'Wound healing assessment using the visual analogue scale (VAS 1-100)', 'timeFrame': 'until day of suture removal (approximately 1 week after surgery)', 'description': 'This parameter will be noted by the surgeon using the Visual Analogue Scale (VAS) which state "0" at one end representing "very good wound healing" and "100" at the opposite end representing "very bad wound healing".'}, {'measure': 'Assessment of the handling of the suture material', 'timeFrame': 'intraoperatively', 'description': "Evaluation of the handling of the suture material in five categories (Knot security, Knot run down, Knot pull tensile strength, Tissue drag, Pliability) with the 5 evaluation levels each: 'excellent', 'very good', 'good', 'satisfied' and 'poor' transferred into the evaluation scores 5, 4, 3, 2 and 1."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tooth distraction', 'Removal of impacted Teeth', 'Oral Surgery', 'Dental Implant', 'Observational Study'], 'conditions': ['Tooth, Impacted', 'Teeth Impact', 'Tooth Impaction', 'Mucosal Wound']}, 'descriptionModule': {'briefSummary': 'Assessment of SILKAM® suture material in mucosal closure in oral surgery (mucosal sutures). A prospective, monocentric, single arm observational study.', 'detailedDescription': 'The aim of this Non Interventional Study is to collect systematically and proactively different clinical parameters regarding safety, effectiveness, and performance of SILKAM® suture material under the daily routine clinical practice when is intended to be used for oral surgery. All patients enrolled will be prospectively followed until suture removal, which takes place approximately one week post-operatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing mucosal closure in oral surgery (mucosal sutures).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing mucosal wound closure using SILKAM® as suture material in oral surgery (in the event that more than one incision is performed in the same patient, only one incision will be considered).\n\nExclusion Criteria:\n\n* Patients taking medication that might affect wound healing\n* Patients having a condition that might affect wound healing.\n* Patients with hypersensitivity or allergy to the suture material.\n* Participation in another (Randomized) Clinical Trial / Clinical Study.\n* Non-compliance of patient (i.e. dementia).'}, 'identificationModule': {'nctId': 'NCT05296902', 'acronym': 'SILKOS', 'briefTitle': 'Performance of Safety of SILKAM® Suture Material in Oral Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Single Center Open-Label Post Market Clinical Follow-Up (PMCF) -Study on the Performance of Safety of SILKAM® Suture Material in Oral Surgery', 'orgStudyIdInfo': {'id': 'AAG-O-H-2038'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SILKAM®', 'description': 'SILKAM® is a non-absorbable sterile suture material made from braided silk fibrils. It is available either undyed (white) or dyed black with hematein and is coated with refined paraffin wax or beeswax.', 'interventionNames': ['Device: Mucosal Closure']}], 'interventions': [{'name': 'Mucosal Closure', 'type': 'DEVICE', 'description': 'mucosal closure in oral surgery (mucosal sutures)', 'armGroupLabels': ['SILKAM®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08195', 'city': 'Sant Cugat del Vallès', 'state': 'Catalonia', 'country': 'Spain', 'facility': "Facultat D'odontologia. Universitat Internacional de Catalunya", 'geoPoint': {'lat': 41.47063, 'lon': 2.08611}}], 'overallOfficials': [{'name': 'Marc Quevedo Pou, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Facultat D'odontologia. Universitat Internacional de Catalunya"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'B.Braun Surgical SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}