{ "FullStudy":{ "Rank":217816, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516463", "OrgStudyIdInfo":{ "OrgStudyId":"017-101-09-031" }, "Organization":{ "OrgFullName":"Healthpoint", "OrgClass":"INDUSTRY" }, "BriefTitle":"Using Santyl or Bacitracin on Second Degree Burns", "OfficialTitle":"Comparison of Collagenase Santyl® Ointment With Antibiotic Ointment in the Outpatient Care of Minor Partial Thickness Burns" }, "StatusModule":{ "StatusVerifiedDate":"May 2012", "OverallStatus":"Withdrawn", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2013", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"December 2013", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 19, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 15, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 16, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Healthpoint", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Subjects who have minor, second degree burns may be enrolled in this study. Subjects will receive either Santyl ointment or bacitracin ointment to apply to the burn until it heals. Bandages will be used to keep the burn covered while it heals. Second degree burns generally leave a scar. Once the burn heals, lotion and an appropriate bandage will be used to try to minimize the appearance of a scar.\n\nThe study hypothesis is that burns treated with Santyl will have a better scar appearance than burns treated with bacitracin.\n\nSubjects enrolled in this study will make once a week visits to the University of Kansas Medical Center outpatient burn clinic until the burn heals. The burn will be assessed for healing at these visits. Once healed, visits to the clinic will be every 1-3 months for up to 1 year. At these visits, the appearance of the scar will be evaluated" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Burn, Partial Thickness" ] }, "KeywordList":{ "Keyword":[ "burn", "partial thickness burn", "second degree burn", "minor burn", "scar", "Santyl", "Bacitracin", "outpatient burn center", "scar appearance", "Kansas City", "University of Kansas Medical Center", "KUMC" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"0", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Collagenase Santyl", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Collagenase Santyl" ] } },{ "ArmGroupLabel":"Bacitracin", "ArmGroupType":"Sham Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Biological: Bacitracin" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Collagenase Santyl", "InterventionDescription":"Applied topically (2 mm thickness once daily)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Collagenase Santyl" ] } },{ "InterventionType":"Biological", "InterventionName":"Bacitracin", "InterventionDescription":"Applied topically (2 mm thickness) once daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Bacitracin" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Scar Appearance", "PrimaryOutcomeTimeFrame":"90 Days" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Proportion healed at two weeks", "SecondaryOutcomeTimeFrame":"2 weeks after initiation of treatment" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nProvide written informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information. For subjects not able to provide informed consent (e.g., minors), a parent or legally authorized representative must provide consent. Assent must be provided as required by the IRB.\nAge 2 - 75 yrs, either sex, any race.\nHave one or more acute burns which:\n• are thermal, chemical or electrical in etiology\n• in aggregate cover <10% TBSA\n• are each equal to or less than 72 hrs old\n• are each no more than deep partial thickness (2nd degree)\n• are not visibly infected\nAble to take in oral fluids.\nAble to comply with the requirement for daily dressing changes, or have a caretaker who is able to comply.\nWilling to make all required study visits.\n\nExclusion Criteria:\n\nContraindications or hypersensitivity to the use of the test article or their components (e.g., known hypersensitivity to bacitracin).\nEmbedded foreign bodies in the burn wound which cannot be immediately removed.\nThe burned tissue includes or is within 1 cm of the eye or genitalia.\nSevere perioral burns.\nAirway involvement or aspiration of hot liquids.\nSuspicion of physical abuse.\nBurn wound requires a skin graft.\nOutpatient management of the burn wound is not appropriate.\nParticipation in another investigational clinical study within thirty (30) days of the Screening Visit.\nCurrent or recent (< 6 months) history of severe, unstable, or uncontrolled neurological, cardiovascular, gastrointestinal, hematological, hepatic, and/or renal disease or evidence of other diseases based upon a review of medical history that, in the opinion of the Investigator, would preclude safe subject participation in the study.\nThe Medical Monitor and / or Investigator may declare any subject ineligible for a valid medical reason.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"2 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Herbert B Slade, MD", "OverallOfficialAffiliation":"Healthpoint", "OverallOfficialRole":"Study Chair" },{ "OverallOfficialName":"Dhaval Bhavsar, MD", "OverallOfficialAffiliation":"University of Kansas Medical Center", "OverallOfficialRole":"Principal Investigator" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020", "RemovedCountryList":{ "RemovedCountry":[ "United States" ] } }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000001414", "InterventionMeshTerm":"Bacitracin" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000891", "InterventionAncestorTerm":"Anti-Infective Agents, Local" },{ "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" },{ "InterventionAncestorId":"D000000900", "InterventionAncestorTerm":"Anti-Bacterial Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M3293", "InterventionBrowseLeafName":"Bacitracin", "InterventionBrowseLeafAsFound":"Bacitracin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2796", "InterventionBrowseLeafName":"Anti-Infective Agents, Local", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2803", "InterventionBrowseLeafName":"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000002056", "ConditionMeshTerm":"Burns" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000014947", "ConditionAncestorTerm":"Wounds and Injuries" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3908", "ConditionBrowseLeafName":"Burns", "ConditionBrowseLeafAsFound":"Burn", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4743", "ConditionBrowseLeafName":"Cicatrix", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M16268", "ConditionBrowseLeafName":"Wounds and Injuries", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC26", "ConditionBrowseBranchName":"Wounds and Injuries" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }