{ "FullStudy":{ "Rank":218155, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512017", "OrgStudyIdInfo":{ "OrgStudyId":"ZHAOKE-VL2010" }, "Organization":{ "OrgFullName":"Lee's Pharmaceutical Limited", "OrgClass":"INDUSTRY" }, "BriefTitle":"Clinical Study on Veloderm for the Treatment of Split-thickness Skin Graft Donor Sites", "OfficialTitle":"A Clinical Study to Evaluate the Safety and Efficacy on Veloderm (a Crystalline Cellulose Simple Occlusive Dressing) for the Split-thickness Skin Graft Donor Sites in Burn and Plastic Surgery" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 2008" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 2010", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2010", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"September 14, 2010", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 24, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 25, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Lee's Pharmaceutical Limited", "LeadSponsorClass":"INDUSTRY" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Ruijin Hospital", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Guangzhou First People's Hospital", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"This study is a multi-center, randomized, open and paralleled positive control study for evaluating the safety and efficacy of Veloderm in treatment of split-thickness skin graft donor sites. The result implies that Veloerm can do it better than Vaseline gauze in accelerating and promoting wound healing of skin graft donor sites. The present study have indicated that high permeability of Veloderm dressing to oxygen and water vapor.", "DetailedDescription":"The rational oxygen permeability of Veloderm dressing also provides a good environment for wound healing. Therefore, it can be as a temporary skin substitute in the case of missing epidermis to play a role, in order to provide an ideal environment for wound epithelialization. As regards safety, 1 adverse reaction occured in test group. It shows effusion under the dressing mild inflammatory infiltration on the wound edge. After the dressing was changed and the effusion was drained, the patient was relieved. As Veloderm dressing itself has no direct anti-inflammatory effects, clinical application as appropriate can plus other anti-infective drugs in accordance with patient conditions. In conclusion, Veloderm is a safe and effective dressing to accelerate the healing of donor sites in burn and plastic surgery. Veloderm can be used as a temporary skin substitute in case of damage of skin or loss of superficial epidermal (such as burns, wounds, abrasions, ulcers, sores and auto-graft donor areas)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Split-thickness Skin Graft Donor Sites" ] }, "KeywordList":{ "Keyword":[ "skin lesions or defects" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Supportive Care", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"96", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Veloderm", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Crystalline cellulose simple occlusive dressing" ] } },{ "ArmGroupLabel":"Vaseline", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Vaseline" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"Crystalline cellulose simple occlusive dressing", "InterventionDescription":"A natural biological film of vegetable origin. It is classified as skin semi occlusive dressing, as a temporary skin substitute in case of skin lesions or loss.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Veloderm" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Veloderm" ] } },{ "InterventionType":"Device", "InterventionName":"Vaseline", "InterventionDescription":"External use", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Vaseline" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Response Criteria", "PrimaryOutcomeDescription":"To observate the efficacy measurements, vital signs, laboratory examinations and adverse events", "PrimaryOutcomeTimeFrame":"3 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Evaluation criteria", "SecondaryOutcomeDescription":"To evaluate the time to complete epithilization, effectiveness, presence of exudates, presence of prei-lesional erythema, pain intensity and laboratory examination", "SecondaryOutcomeTimeFrame":"6 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAged 18-65 years\nMale or female patients\nSkin lesions or losses by burns, plastic surgery, sores, abrasions, donor graft areas and after debridement of chronic wounds\nThe area of skin loss or burn surface is less than 50% of total area of body surface\nSubject undergoing first skin harvest 0.25-0.35mm and donor site having a surface area>100cm2\nSubject who is willing to participate in the trial and to sign the informed consent form.\n\nExclusion Criteria:\n\nArea of skin loss or burn surface is larger than 50% of total area of body surface\nElectrical burns or chemical burns\nBurns complicated by combined injury\nTest wound needs drugs that may affect wound healing\nSubject who has a known hypersensitivity to hemycellulose\nContraindication to the use of semi occlusive dressing\nPregnant or lactating subject\nAny severe disease which in the Investigator's judgement might interfere with study evaluations or threaten patient's safety\nSubject who has chronic renal disease or renal inadequacy, or serum creatinine is more than twice the upper limit of normal\nSubject who has a definite liver disease, TBil or AST, ALT is more than twice the upper limit of normal\nSubject with active hemorrhoea or shock or visceral injury; Subject who has participated in this clinical study or other clinical studies within 3 months\nSubject with mental impairment limiting the ability to comply with study requirements; Subject undergone chronic treatment with immunosuppressants, antineoplastic drugs and corticosteroids for a long time\nSubject who has not signed the informed consent form.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000010577", "InterventionMeshTerm":"Petrolatum" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000004643", "InterventionAncestorTerm":"Emollients" },{ "InterventionAncestorId":"D000003879", "InterventionAncestorTerm":"Dermatologic Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M12068", "InterventionBrowseLeafName":"Petrolatum", "InterventionBrowseLeafAsFound":"Vaseline", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M6392", "InterventionBrowseLeafName":"Emollients", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M5657", "InterventionBrowseLeafName":"Dermatologic Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Derm", "InterventionBrowseBranchName":"Dermatologic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3908", "ConditionBrowseLeafName":"Burns", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC26", "ConditionBrowseBranchName":"Wounds and Injuries" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }