Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-28 @ 10:37 PM
Study NCT ID:
NCT01835405
Status:
COMPLETED
Last Update Posted:
2017-01-24
First Post:
2013-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013537', 'term': 'Sutures'}], 'ancestors': [{'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-23', 'studyFirstSubmitDate': '2013-04-12', 'studyFirstSubmitQcDate': '2013-04-18', 'lastUpdatePostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare cosmetic outcomes at follow up', 'timeFrame': '3 months post treatment', 'description': 'Cosmesis to be evaluated by a panel of masked evaluators using a modified Hollander Wound Evaluation Scale'}]}, 'conditionsModule': {'conditions': ['Surgical Incisions']}, 'descriptionModule': {'briefSummary': 'To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety of LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the topical closure of surgical wounds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female aged 18 or older on day of enrollment\n* Scheduled for surgical procedure by a delegated study surgeon\n* Fresh surgical wound with evenly distributed tension over length of incision\n* Willing and able to sign informed consent\n* Agree to return for 2 week (+/- 7 days) and 3 month (90 days +/- 7 days) post-procedure follow-up visit\n\nExclusion Criteria:\n\n* Known sensitivity to cyanoacrylates, formaldehyde or acetone products\n* Wounds in which incision edges are under high tension or not easily apposed (after deep layer suture), or over joints (unless immobilized)\n* Wounds less than 15mm in length\n* Wounds in which haemostasis is not able to be achieved, eg, drain is placed or Warfarin level \\>2.5 prior to surgery\n* Wounds in which deep closure could not be achieved\n* Surgical procedures involving mucus membranes or eyes\n* Mental incapacity, dementia, or inability to give informed consent\n* Pregnant or nursing\n* Disease related or pharmacologically immuno-compromised'}, 'identificationModule': {'nctId': 'NCT01835405', 'briefTitle': 'LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Advanced Medical Solutions Ltd.'}, 'officialTitle': 'A Prospective, Single-centre Study to Compare the Use of LiquiBand® Flex, Dermabond Advanced™ or Conventional Sutures for the Topical Closure of Surgical Wounds', 'orgStudyIdInfo': {'id': 'D-LBF001-05-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LiquiBand Flex', 'description': 'LiquiBand® Flex skin adhesive is indicated for topical application only, to hold closed easily approximated skin edges from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed trauma-induced lacerations. It may be used in conjunction with, but not in place of deep dermal sutures.', 'interventionNames': ['Device: LiquiBand Flex']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dermabond Advanced', 'description': 'Dermabond Advanced™ adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Dermabond Advanced ™ adhesive may be used in conjunction with, but not in place of, deep dermal stitches.', 'interventionNames': ['Device: Dermabond Advanced']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sutures (Prolene)', 'description': 'Prolene™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.', 'interventionNames': ['Device: Sutures (Prolene)']}], 'interventions': [{'name': 'LiquiBand Flex', 'type': 'DEVICE', 'armGroupLabels': ['LiquiBand Flex']}, {'name': 'Dermabond Advanced', 'type': 'DEVICE', 'armGroupLabels': ['Dermabond Advanced']}, {'name': 'Sutures (Prolene)', 'type': 'DEVICE', 'armGroupLabels': ['Sutures (Prolene)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01915', 'city': 'Beverly', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Oncology Care Center, Beverly Hospital', 'geoPoint': {'lat': 42.55843, 'lon': -70.88005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Advanced Medical Solutions Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}