Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT04390620
Status:
COMPLETED
Last Update Posted:
2021-12-22
First Post:
2020-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures)
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': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-21', 'studyFirstSubmitDate': '2020-05-07', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bacterial contamination of the thread', 'timeFrame': 'at suture removal 10 ± 5 days postoperative', 'description': 'optional'}, {'measure': 'Pain assessment using the visual analogue scale (VAS 1-100)', 'timeFrame': 'at follow-up up to five months postoperative', 'description': 'Optional: 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': 'at follow-up up to five months postoperative', 'description': 'Optional: 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': 'at follow-up up to five months postoperative', 'description': 'Optional: 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': 'Cosmetic outcome assessed by the physician using the visual analogue scale (VAS 1-100)', 'timeFrame': 'at follow-up up to five months postoperative', 'description': 'Optional: This parameter will be noted by the surgeon using the Visual Analogue Scale (VAS) which state "0" at one end representing "very good cosmetic outcome" and "100" at the opposite end representing "very bad cosmetic outcome".'}], 'primaryOutcomes': [{'measure': 'incidence of combined postoperative complications Grade I and Grade II', 'timeFrame': '10 ± 5 days postoperatively (suture removal)', 'description': 'combined incidence of postoperative complications Grade I \\& II on a Five Point scale defined by Askar et al. (Grade I: postoperative dentinal hypersensitivity / Oral candidiasis / Angular cheilitis / Exaggerated swelling defined as postoperative enlargement of tissues that exceeds the normal limits associated with a given surgical procedure / Delayed wound healing defined as an unusual deviation from the normal course of healing / Mild postoperative bleeding defined as the presence of small amount of blood in the oral cavity, usually mixed with saliva; Grade II: Flap dehiscence / Membrane exposure / Localized infection of the surgical site / Graft necrosis)'}], 'secondaryOutcomes': [{'measure': 'Incidence of individual postoperative complications', 'timeFrame': 'until suture removal 10 ± 5 days postoperative', 'description': 'incidence of postoperative complications of Grade I - V on a Five Point scale defined by Askar et al. (Grade I \\& II see Primary Outcome; Grade III: Fever / Skin rash / Neuropraxia/paresthesia / Trimus / Osteomyelitis / Septicemia / Sinusitis / Alveolar osteitis / Chymosis / Excessive and severe bleeding / Prolonged exaggerated swelling; Grade IV: Major complications that required immediate hospitalization such as drug induced anaphylaxis or septicemia; Grade V: Major complications that led to irreversible damage such neurotmesis and axonotmesis)'}, {'measure': 'Pain assessment using the visual analogue scale (VAS 1-100)', 'timeFrame': 'at suture removal 10 ± 5 days postoperative', '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': 'at suture removal 10 ± 5 days postoperative', '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': 'at suture removal 10 ± 5 days postoperative', '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': 'knot security', 'timeFrame': 'intraoperative', 'description': "Evaluation of Knot security with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,"}, {'measure': 'tensile strength', 'timeFrame': 'intraoperative', 'description': "Evaluation of tensile strength with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,"}, {'measure': 'knot run down', 'timeFrame': 'intraoperative', 'description': "Evaluation of knot run down with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,"}, {'measure': 'tissue drag', 'timeFrame': 'intraoperative', 'description': "Evaluation of tissue drag with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,"}, {'measure': 'pliability', 'timeFrame': 'intraoperative', 'description': "Evaluation of pliability with the 5 evaluation levels 'excellent', 'very good', 'good', 'satisfied' and 'poor' into the evaluation scores 5, 4, 3, 2 and 1,"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral surgery', 'mucosal closure', 'complication rate'], 'conditions': ['Oral Surgery', 'Tooth Extraction', 'Dental Implants']}, 'descriptionModule': {'briefSummary': 'In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients', 'detailedDescription': 'In this non-interventional study (NIS) a polyamide non-absorbable suture (Dafilon) will be evaluated for oral surgery (mucosal closure after e.g. wisdom teeth extraction, implant surgery, etc.) in adult patients.\n\nThe aim of this NIS is to collect systematically and proactively different clinical parameters regarding safety, effectiveness and performance of Dafilon 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 10 ± 5 days post-operatively (and post-operatively depending on routine clinical practice of each hospital).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients undergoing mucosal wound closure using Dafilon 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 included).\n* Written informed consent regarding the data collection for the PMCF.\n\nExclusion Criteria:\n\n* Emergency surgery.\n* Oral surgery procedures requiring bone regeneration.\n* Pregnancy.\n* Patients taking medication that might affect wound healing.\n* Patients with hypersensitivity or allergy to the suture material.'}, 'identificationModule': {'nctId': 'NCT04390620', 'acronym': 'MUCODA', 'briefTitle': 'Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'Assessment of DAFILON® Suture Material in Oral Surgery (Mucosal Sutures). A Prospective, Single Arm Observational Study in Daily Practice', 'orgStudyIdInfo': {'id': 'AAG-O-H-1912'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MUCODA', 'description': 'DAFILON - sterile, monofilament, non-absorbable surgical suture material produced from Polyamide', 'interventionNames': ['Device: Mucosal Closure']}], 'interventions': [{'name': 'Mucosal Closure', 'type': 'DEVICE', 'description': 'mucosal closure in oral surgery (mucosal sutures)', 'armGroupLabels': ['MUCODA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73728', 'city': 'Esslingen am Neckar', 'country': 'Germany', 'facility': 'Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie, Ästhetische und Plastische Chirurgie', 'geoPoint': {'lat': 48.73961, 'lon': 9.30473}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Universitat Internacional de Catalunya (UIC)', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Nils Weyer, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Praxisklinik für Mund-, Kiefer- und Gesichtschirurgie Ästhetische und Plastische Chirurgie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'B.Braun Surgical SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}