Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-06 @ 12:00 PM
Study NCT ID:
NCT03410433
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2018-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suture Materials: an Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-24', 'studyFirstSubmitDate': '2018-01-18', 'studyFirstSubmitQcDate': '2018-01-24', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accumulation of soft deposits', 'timeFrame': '7 to 14 days', 'description': 'Accumulation of soft deposits on each suture material was assessed visually as being present or absent before removing the knots.'}], 'secondaryOutcomes': [{'measure': 'Area of inflammation', 'timeFrame': '7 to 14 days', 'description': 'Clinical photographs were taken, calibrated with a ruler of 0.5 mm accuracy as is illustrated in Figure 2, before and after suture removal in both parts of the clinical study. Subsequently, the area of inflammation surrounding the sutures was measured by two separate examiners using the image-analysis program, Image J® (NIH, Bethesda, Maryland, USA).'}, {'measure': 'Microbial deposits on the sutures', 'timeFrame': '7 to 14 days', 'description': 'The composition of the microbial deposits on the suture materials was examined with qPCR.'}]}, 'conditionsModule': {'conditions': ['Suture Materials']}, 'descriptionModule': {'briefSummary': "Background: Many factors play a role when selecting an appropriate suture for optimal soft tissue healing in oral surgery. Moreover, the oral cavity has its specific challenges: it is an aqueous environment in which biofilm formation takes place on all surfaces. Therefore, oral surgery has specific demands for suture materials.\n\nAim: The primary objective of this study was to compare the bacterial load on different suture materials. The secondary objective was to determine the impact of suture material on decubitus.\n\nMaterial \\& methods: This prospective experimental study with a 'split-mouth' design enrolled 36 patients requiring oral surgery. Five different suture materials were compared regarding their microbiological load and decubitus at the suture removal. Bacterial accumulation on the same 5 suture materials was also tested in an in vitro biofilm model."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 36 patients\n* in need for periodontal surgery\n* patients in good general health\n* able to sign IC form\n\nExclusion Criteria:\n\n* patients that were deemed unlikely to comply with the study protocol, as judged by the examiner\n* patients who had a present alcohol and/or drug abuse'}, 'identificationModule': {'nctId': 'NCT03410433', 'briefTitle': 'Suture Materials: an Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Split-mouth Analysis of Different Suture Materials in Periodontal Surgery: Microbiological and Clinical Aspects', 'orgStudyIdInfo': {'id': 'S58697'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Silk 4.0', 'description': 'Silk suture', 'interventionNames': ['Device: Silk 4.0']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PG910 4.0', 'description': 'Vicryl Rapid suture', 'interventionNames': ['Device: PG 910 4.0']}, {'type': 'EXPERIMENTAL', 'label': 'PP 4.0', 'description': 'Non-absorbable polypropylene monofilament', 'interventionNames': ['Device: PP 4.0']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Silk 5.0', 'description': 'Silk suture', 'interventionNames': ['Device: Silk 5.0']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PG910 5.0', 'description': 'Vicryl suture', 'interventionNames': ['Device: PG910 5.0']}, {'type': 'EXPERIMENTAL', 'label': 'PP 5.0', 'description': 'Non-absorbable polypropylene monofilament', 'interventionNames': ['Device: PP 5.0']}, {'type': 'EXPERIMENTAL', 'label': 'APG 5.0', 'description': 'Antibacterial Vicryl suture', 'interventionNames': ['Device: APG 5.0']}, {'type': 'EXPERIMENTAL', 'label': 'ePTFE 5.0', 'description': 'expanded polytetrafluoroethylene', 'interventionNames': ['Device: ePTFE 5.0']}], 'interventions': [{'name': 'Silk 4.0', 'type': 'DEVICE', 'description': 'Silk suture 4.0', 'armGroupLabels': ['Silk 4.0']}, {'name': 'PG 910 4.0', 'type': 'DEVICE', 'description': 'PG 910 4.0', 'armGroupLabels': ['PG910 4.0']}, {'name': 'PP 4.0', 'type': 'DEVICE', 'description': 'PP 4.0', 'armGroupLabels': ['PP 4.0']}, {'name': 'Silk 5.0', 'type': 'DEVICE', 'description': 'Silk 5.0', 'armGroupLabels': ['Silk 5.0']}, {'name': 'PG910 5.0', 'type': 'DEVICE', 'description': 'PG910 5.0', 'armGroupLabels': ['PG910 5.0']}, {'name': 'PP 5.0', 'type': 'DEVICE', 'description': 'PP 5.0', 'armGroupLabels': ['PP 5.0']}, {'name': 'APG 5.0', 'type': 'DEVICE', 'description': 'APG 5.0', 'armGroupLabels': ['APG 5.0']}, {'name': 'ePTFE 5.0', 'type': 'DEVICE', 'description': 'ePTFE 5.0', 'armGroupLabels': ['ePTFE 5.0']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Marc Quirynen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'KU Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}