Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT00766727
Status:
COMPLETED
Last Update Posted:
2020-12-14
First Post:
2008-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jzepeda@neodynebio.com', 'phone': '5104564128', 'title': 'VP, R&D/OPS', 'phoneExt': '128', 'organization': 'Neodyne'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'The incidence and severity of wound related adverse events and infections will be summarized and compared between those that occur on the GLYDe Dressing treated side and those that occur on the control side. All available data will be used. No imputation will be performed for missing data for any analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'GLYDe Dressing', 'description': 'Investigational Dressing\n\nGLYDe Dressing: Wound dressing intended to minimize scar formation', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Standard of care comparator', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLYDe Dressing (Treated)', 'description': "The interventions provided consisted of a GLYDe dressing which was randomly assigned to the left or right side of the patient's abdomen. The opposite side of the intervention received the standard of care (SoC).\n\nFor example, one patient wore a GLYDe Dressing on Left Side, and SoC Right Side while another patient wore GLYDe Dressing Right Side, and SoC Left Side."}, {'id': 'OG001', 'title': 'SoC (Control)', 'description': 'Standard of care treatment group, used as the control. The opposite side of the intervention received the standard of care (SoC). For example, one patient wore a GLYDe Dressing on Left Side, and SoC on Right Side while another patient wore GLYDe Dressing Right Side, and SoC on Left Side.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.64', 'spread': '10.86', 'groupId': 'OG000'}, {'value': '50.52', 'spread': '15.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-31.88', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '14.25', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'through 12 months', 'description': 'Professional photographs were taken 12 months postsurgery and evaluated by lay and professional panels. A 100 point Visual Analog Scale (VAS), ranging from a score of 0 for a better outcome to a score of 100 for worse outcome, will be used to assess both the Treated and Control scars at the same timepoint.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient population undergoing elective plastic surgery.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': "The interventions provided consisted of a GLYDe dressing which was randomly assigned to the left or right side of the patient's abdomen. The opposite side of the intervention received the standard of care (SoC).\n\nFor example, one patient wore a GLYDe Dressing on Left Side, and SoC Right Side while another patient wore GLYDe Dressing Right Side, and SoC Left Side."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': "The interventions provided consisted of a GLYDe dressing which was randomly assigned to the left or right side of the patient's abdomen. The opposite side of the intervention received the standard of care (SoC).\n\nFor example, one patient wore a GLYDe Dressing on Left Side, and SoC Right Side while another patient wore GLYDe Dressing Right Side, and SoC Left Side."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '53'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2008-10-03', 'resultsFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2008-10-03', 'lastUpdatePostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-11', 'studyFirstPostDateStruct': {'date': '2008-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control)', 'timeFrame': 'through 12 months', 'description': 'Professional photographs were taken 12 months postsurgery and evaluated by lay and professional panels. A 100 point Visual Analog Scale (VAS), ranging from a score of 0 for a better outcome to a score of 100 for worse outcome, will be used to assess both the Treated and Control scars at the same timepoint.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['incision', 'abdominoplasty'], 'conditions': ['Post Surgical Incisions From Abdominoplasty Procedures']}, 'referencesModule': {'references': [{'pmid': '21606834', 'type': 'DERIVED', 'citation': 'Gurtner GC, Dauskardt RH, Wong VW, Bhatt KA, Wu K, Vial IN, Padois K, Korman JM, Longaker MT. Improving cutaneous scar formation by controlling the mechanical environment: large animal and phase I studies. Ann Surg. 2011 Aug;254(2):217-25. doi: 10.1097/SLA.0b013e318220b159.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate a new dressing to be used for post-incision care for abdominoplasty patients. The hypothesis is that this dressing will minimize scar formation.', 'detailedDescription': 'This study will evaluate a new dressing in up to 30 patients who have undergone an abdominoplasty procedure. They will wear the dressing through 8 weeks post surgery and the scar will be evaluated at 3 months post surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects who have undergone an abdominoplasty 1 week prior to study participation\n\nExclusion Criteria:\n\n* subjects with a history of collagen vascular disease or scleroderma\n* subjects with known adverse reactions to steri-strips, medical tapes or adhesives'}, 'identificationModule': {'nctId': 'NCT00766727', 'acronym': 'Mona Lisa', 'briefTitle': 'Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neodyne Biosciences, Inc.'}, 'officialTitle': 'Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care', 'orgStudyIdInfo': {'id': 'CA001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLYDe Dressing', 'description': 'Investigational Dressing', 'interventionNames': ['Device: GLYDe Dressing']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Standard of care comparator'}], 'interventions': [{'name': 'GLYDe Dressing', 'type': 'DEVICE', 'description': 'Wound dressing intended to minimize scar formation', 'armGroupLabels': ['GLYDe Dressing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Josh Korman, MD', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}], 'overallOfficials': [{'name': 'Michael Longaker, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Neodyne Biosciences, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neodyne Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}