{ "FullStudy":{ "Rank":217975, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514383", "OrgStudyIdInfo":{ "OrgStudyId":"R11-009" }, "Organization":{ "OrgFullName":"Medline Industries", "OrgClass":"INDUSTRY" }, "BriefTitle":"Octylseal Surgical Adhesive in General Surgery", "OfficialTitle":"Evaluation of Octylseal as a Topical Surgical Skin Incision Adhesive in General Surgery: A Case Series" }, "StatusModule":{ "StatusVerifiedDate":"May 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"August 28, 2017", "ResultsFirstSubmitQCDate":"May 6, 2019", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"May 7, 2019", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"May 6, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 7, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Medline Industries", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate how surgical adhesive is used.", "DetailedDescription":"In this Case Series Study, clinician experience and subject outcomes will be recorded in the use of a topical skin adhesive (Octylseal) on the closure of skin incisions from General surgical procedures." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Wounds" ] }, "KeywordList":{ "Keyword":[ "wounds" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"34", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Surgical Adhesive", "ArmGroupType":"Experimental", "ArmGroupDescription":"The surgical adhesive (cyanoacrylate) will be used once to close the topical skin surgical incision created during surgical procedures.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Cyanoacrylate (Octylseal )" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Cyanoacrylate (Octylseal )", "InterventionDescription":"surgical adhesive", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Surgical Adhesive" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "cyanoacrylate" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Wound Length Closure", "PrimaryOutcomeDescription":"Primary incision wound length treatment in adult and pediatric general surgery", "PrimaryOutcomeTimeFrame":"During Surgery" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Number of Participants With a Score of \"0\" (No Hurt) on the Pain Rating Scale", "SecondaryOutcomeDescription":"Pain was assessed using the Wong-Baker FACES™ Pain Rating Scale, with 0 =No Hurt to 10=Hurts Worst", "SecondaryOutcomeTimeFrame":"At Surgery" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nCandidate for use of a topical surgical skin adhesive\n\nExclusion Criteria:\n\nSubjects with know sensitivity to topical surgical tissue adhesive products or degrading products (cyanoacrylates or formaldehyde)\nSubjects with a history of keloid formation, hypotension, insulin dependent diabetes mellitus, blood/clotting disorders, peripheral vascular diseases or hypertrophy history\nSubjects who present with a contraindications for product usage as per labeling\nA wound with evidence of active infection or gangrene or wounds of decubitus etiology\nMucosal surfaces or across mucocutaneous junctions or skin that might be exposed to bodily fluids or with dense natural hair\nSubjects with known hypersensitivity to cyanoacrylate or formaldehyde", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"8 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Ed Drower, MS", "OverallOfficialAffiliation":"Medline Industries", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Jersey City Medical Center", "LocationCity":"Jersey City", "LocationState":"New Jersey", "LocationZip":"07302", "LocationCountry":"United States" },{ "LocationFacility":"Wyckoff Hospital", "LocationCity":"New York", "LocationState":"New York", "LocationZip":"11237", "LocationCountry":"United States" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Surgical Adhesive", "FlowGroupDescription":"Cyanoacrylate (Octylseal ): surgical adhesive" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"34" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"34" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Octylseal" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"34" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Adult", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"47.5", "BaselineMeasurementSpread":"17.5" } ] } } ] } },{ "BaselineClassTitle":"Pediatric", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11.3", "BaselineMeasurementSpread":"2.8" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineMeasureCalculatePct":"No", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"17" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"17" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"34" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Wound Length Closure", "OutcomeMeasureDescription":"Primary incision wound length treatment in adult and pediatric general surgery", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"milimeters", "OutcomeMeasureTimeFrame":"During Surgery", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Wound Length Closure of Paticipants Treated With Octylseal" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"34" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Adult", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"28.97", "OutcomeMeasurementSpread":"24.68" } ] } } ] } },{ "OutcomeClassTitle":"Pediatric", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"21.00", "OutcomeMeasurementSpread":"10.98" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With a Score of \"0\" (No Hurt) on the Pain Rating Scale", "OutcomeMeasureDescription":"Pain was assessed using the Wong-Baker FACES™ Pain Rating Scale, with 0 =No Hurt to 10=Hurts Worst", "OutcomeMeasurePopulationDescription":"All 34 participants", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"At Surgery", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"No Pain Reported", "OutcomeGroupDescription":"Wong-Baker FACES™ Pain Rating Scale Pain Rating Scale from 0-10, with 0 =No Hurt to 10=Hurts Worst" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"34" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"34" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"14 days", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Octylseal", "EventGroupDeathsNumAffected":"0", "EventGroupDeathsNumAtRisk":"34", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"34", "EventGroupOtherNumAffected":"1", "EventGroupOtherNumAtRisk":"34" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Infection", "OtherEventOrganSystem":"Infections and infestations", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventNotes":"Of 74 incisions/lacerations treated in 34 patients, there was one (1) documented report of a possible incisional infection (1.4%). The complication was deemed not related to octylseal™.", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"34" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Ed Drower, Clinical Project Director", "PointOfContactOrganization":"Medline Industries, Inc", "PointOfContactEMail":"edrower@medline.com", "PointOfContactPhone":"847-643-3874" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M16268", "ConditionBrowseLeafName":"Wounds and Injuries", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M1112", "ConditionBrowseLeafName":"Surgical Wound", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC26", "ConditionBrowseBranchName":"Wounds and Injuries" } ] } } } } } }