{
  "FullStudy":{
    "Rank":217998,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514084",
          "OrgStudyIdInfo":{
            "OrgStudyId":"1108-081"
          },
          "Organization":{
            "OrgFullName":"Children's Hospitals and Clinics of Minnesota",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Cosmetic Outcomes and Patient Satisfaction After Facial Laceration Repair in the Emergency Department"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 12, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 21, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 23, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Children's Hospitals and Clinics of Minnesota",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"Facial lacerations are commonly treated in the emergency department. The nature of the injury leads to a great deal of concern about the long-term cosmetic appearance of the wounds.\n\nResearch Questions\n\nWhat is the association between wound characteristics, wound management in the ED, patient satisfaction in the ED, and patient-rated cosmetic appearance of sutured wounds?\nIs there a difference noted among ED providers with different levels of training?\nIs there an association between initial satisfaction scores and wound outcome?\nIs there an association between short term and long term wound scores?\n\nDesign This is a non-randomized, prospective, observational study of patients who present to the ED seeking treatment for facial laceration repair."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Facial Lacerations"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "laceration",
              "emergency",
              "cosmetic outcomes",
              "patient satisfaction",
              "suture"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"160",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"PEM group",
                "ArmGroupDescription":"Patients whose lacerations have been repaired by PEM trained physicians."
              },{
                "ArmGroupLabel":"GP group",
                "ArmGroupDescription":"Patients whose lacerations have been repaired by general pediatricians."
              },{
                "ArmGroupLabel":"PNP group",
                "ArmGroupDescription":"Patients whose lacerations have been repaired by PNPs."
              },{
                "ArmGroupLabel":"RN group",
                "ArmGroupDescription":"Patients whose lacerations have been repaired by suture RNs."
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Cosmetic outcome",
                "PrimaryOutcomeDescription":"Cosmetic Visual Analog Score and the Wound Evaluation Score",
                "PrimaryOutcomeTimeFrame":"6 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Satisfaction score",
                "SecondaryOutcomeDescription":"Visual analog scale; left end labeled \"Dissatisified\" and right end labeled \"Very satisfied\"",
                "SecondaryOutcomeTimeFrame":"6 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nFamilies presenting to the ED for repair of facial laceration will be approached for study inclusion if:\n\nTheir child seeking treatment is less than 18 years of age\nThe laceration was sustained less than 12 hours prior to presentation to Children's ED\nThey speak English\n\nExclusion Criteria:\n\nFamilies presenting to the ED for repair of facial laceration will be excluded from study participation if they:\n\nAre medically complex children\nHave a history of pre-existing coagulopathy or collagen vascular disease\nHave a history of immunodeficiency or diabetes mellitus\nAre suspected of non-accidental trauma\nHave wounds that could be approximated by tissue adhesives\nHave animal or human bites\nHave gross contamination\nHave puncture wounds\nHave lacerations of tendon/nerve/cartilage\nHave scalp lacerations\nDo not speak English",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MaximumAge":"17 Years",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          },
          "StudyPopulation":"Pediatric emergency department",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Children's Hospitals and Clinics of Minnesota",
                "LocationCity":"Twin Cities",
                "LocationState":"Minnesota",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"9660284",
                "ReferenceType":"background",
                "ReferenceCitation":"Quinn JV, Wells GA. An assessment of clinical wound evaluation scales. Acad Emerg Med. 1998 Jun;5(6):583-6."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000022125",
                "ConditionMeshTerm":"Lacerations"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000014947",
                "ConditionAncestorTerm":"Wounds and Injuries"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M6379",
                "ConditionBrowseLeafName":"Emergencies",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M19673",
                "ConditionBrowseLeafName":"Facies",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21369",
                "ConditionBrowseLeafName":"Lacerations",
                "ConditionBrowseLeafAsFound":"Laceration",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC26",
                "ConditionBrowseBranchName":"Wounds and Injuries"
              }
            ]
          }
        }
      }
    }
  }
}