Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-01-04 @ 3:44 PM
Study NCT ID:
NCT03624192
Status:
TERMINATED
Last Update Posted:
2024-07-18
First Post:
2018-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012868', 'term': 'Skin Abnormalities'}], 'ancestors': [{'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'USClinicalTrials@avitamedical.com', 'phone': '661-367-9170', 'title': 'VP, Clinical Research', 'organization': 'AVITA Medical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '52 Weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Experimental: All Participants (Within Patient Control)', 'description': 'Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.\n\nRECELL + Telfa™ Clear and Xeroform™ dressings\n\nRECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings\n\nTelfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Graft Loss 135cm2', 'notes': 'Graft loss due to shearing of a non-study site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Complete Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'units': 'Site', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RECELL', 'description': 'Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.\n\nRECELL + Telfa™ Clear and Xeroform™ dressings\n\nRECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings\n\nTelfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings'}, {'id': 'OG001', 'title': 'Control', 'description': 'Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.\n\nRECELL + Telfa™ Clear and Xeroform™ dressings\n\nRECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings\n\nTelfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings'}], 'classes': [{'title': 'Subject 001', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Subject 003', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Subject 004', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 4 weeks', 'description': 'The primary effectiveness endpoint is time, in days, to complete closure (≥95% epithelialization by blinded assessor) of study donor sites confirmed at two consecutive visits.', 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Site', 'denomUnitsSelected': 'Site'}, {'type': 'SECONDARY', 'title': 'Donor Site Treatment Preference (Site A or Site B) Reported by Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Treatment: RECELL + Telfa™ Clear and Xeroform™ dressings. RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings\n\nControl: Telfa and Xeroform only'}], 'classes': [{'title': 'RECELL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Control', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'No Response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Subject will be asked which donor site (A or B) they prefer (if subject is less than 8 years of age parents will be asked)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Donor Site Treatment Preference (Site A or Site B) Reported by Physician', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Treatment: RECELL + Telfa™ Clear and Xeroform™ dressings. RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings\n\nControl: Telfa and Xeroform only'}], 'classes': [{'title': 'RECELL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Control', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unable to determine/no preference', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': 'Physician will be asked which donor site (A or B) they prefer', 'unitOfMeasure': 'Physician Response', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Treatment: RECELL + Telfa™ Clear and Xeroform™ dressings. RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings\n\nControl: Telfa and Xeroform only'}], 'classes': [{'title': 'RECELL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Control', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': "No difference/Can't tell", 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7', 'description': 'Comparative Itching of study donor sites during 1st week post treatment by asking which site was itchier after treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Treatment: RECELL + Telfa™ Clear and Xeroform™ dressings. RECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings\n\nControl: Telfa and Xeroform only'}], 'classes': [{'title': 'RECELL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Control', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'No Pain at Either Donor SIte', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': "No Difference/Can't Tell", 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7 or 8', 'description': 'Comparative pain of study donor sites during 1st week post treatment by asking the child which site was more painful since treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RECELL', 'description': 'Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.\n\nRECELL + Telfa™ Clear and Xeroform™ dressings\n\nRECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings\n\nTelfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings'}, {'id': 'OG001', 'title': 'Control', 'description': 'Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.\n\nRECELL + Telfa™ Clear and Xeroform™ dressings\n\nRECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings\n\nTelfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings'}], 'classes': [{'title': 'Subject 001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Subject 003', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Subject 004', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Blinded Evaluator Overall Opinion POSAS Score of study donor sites. The Overall Opinion Score uses a 10-point scale where 10 corresponds to the worst imaginable scar.', 'unitOfMeasure': 'Score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected for subject 001'}, {'type': 'SECONDARY', 'title': 'Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RECELL® Autologous Cell Harvesting Device', 'description': 'RECELL + Telfa™ Clear and Xeroform™ dressings\n\nRECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings'}, {'id': 'OG001', 'title': 'Telfa™ Clear and Xeroform™ Dressings', 'description': 'Telfa™ Clear and Xeroform™ dressings\n\nTelfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings'}], 'classes': [{'title': 'Subject 001', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Subject 003', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Subject 004', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Patient Overall Opinion POSAS Score of study donor sites(reported by subject 8 years of age or older, or by parent/guardian if subject less than 8 years of age). The Overall Opinion Score uses a 10-point scale where 10 corresponds to the worst imaginable scar.', 'unitOfMeasure': 'Score on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected from subjects 001 and 004'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Investigator's (Unblinded) Assessment of Healing at All RECELL-treated Areas by Direct Observation", 'timeFrame': 'Through Week 52', 'description': "Investigator's (unblinded) assessment of healing at all RECELL-treated areas including study donor sites by direct observation", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Subject Reported Pain Score Before and After Dressing Changes', 'timeFrame': 'Up to Week 4', 'description': "Mean subject (or parent/guardian) reported study donor site pain prior to and after dressing changes. Faces Pain Scale-Revised (FPS-R) or Numeric Rated Pain Scale will be used based on the child's age. Both scales use a 10-point scale where 10 is the worst pain imaginable or very much pain.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Subject Reported Study Donor Site Itching Score Prior to Dressing Changes', 'timeFrame': 'Up to Week 4', 'description': 'Mean subject (or parent/guardian) reported study donor site itching score prior to dressing changes using the Itch Man Scale (0-4) where 4 represents itching most terribly', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Health Care Provider's Mean Pain Score Associated With Dressing Changes at Study Donor Sites", 'timeFrame': 'Up to Week 4', 'description': 'Mean pain score associated with dressing changes at study donor sites assessed by the health care provider performing the dressing change using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The scale is scored in a range of 0-10 with 0 representing no pain.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Blinding Effectiveness by Asking the Blinded Evaluator Which Treatment They Think the Donor Sites (A and B) Received', 'timeFrame': 'Week 4 and 24', 'description': 'Blinding effectiveness by asking the Blinded Evaluator which treatment they think the donor sites (A and B) received', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RECELL', 'description': 'Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.\n\nRECELL + Telfa™ Clear and Xeroform™ dressings\n\nRECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings\n\nTelfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings'}, {'id': 'FG001', 'title': 'Control', 'description': 'very subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.\n\nRECELL + Telfa™ Clear and Xeroform™ dressings\n\nRECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings\n\nTelfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '3'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '2'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'Donor site', 'preAssignmentDetails': 'Every subject received both interventions (RECELL and CONTROL) such that each subject served as their own control.\n\nRECELL + Telfa™ Clear and Xeroform™ dressings\n\nRECELL® Autologous Cell Harvesting Device: Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings\n\nTelfa™ Clear and Xeroform™ dressings: Telfa™ Clear and Xeroform™ dressings'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental: All Participants (Within Patient Control)', 'description': 'All subjects receive both RECELL and Control. Each subject serves as their own control.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '2.08', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-30', 'size': 257008, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-09T20:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Each subject serves as their own control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Study closed in response to COVID-19 and overall program objectives.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2018-07-20', 'resultsFirstSubmitDate': '2021-07-07', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-07', 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Investigator's (Unblinded) Assessment of Healing at All RECELL-treated Areas by Direct Observation", 'timeFrame': 'Through Week 52', 'description': "Investigator's (unblinded) assessment of healing at all RECELL-treated areas including study donor sites by direct observation"}, {'measure': 'Mean Subject Reported Pain Score Before and After Dressing Changes', 'timeFrame': 'Up to Week 4', 'description': "Mean subject (or parent/guardian) reported study donor site pain prior to and after dressing changes. Faces Pain Scale-Revised (FPS-R) or Numeric Rated Pain Scale will be used based on the child's age. Both scales use a 10-point scale where 10 is the worst pain imaginable or very much pain."}, {'measure': 'Mean Subject Reported Study Donor Site Itching Score Prior to Dressing Changes', 'timeFrame': 'Up to Week 4', 'description': 'Mean subject (or parent/guardian) reported study donor site itching score prior to dressing changes using the Itch Man Scale (0-4) where 4 represents itching most terribly'}, {'measure': "Health Care Provider's Mean Pain Score Associated With Dressing Changes at Study Donor Sites", 'timeFrame': 'Up to Week 4', 'description': 'Mean pain score associated with dressing changes at study donor sites assessed by the health care provider performing the dressing change using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The scale is scored in a range of 0-10 with 0 representing no pain.'}, {'measure': 'Blinding Effectiveness by Asking the Blinded Evaluator Which Treatment They Think the Donor Sites (A and B) Received', 'timeFrame': 'Week 4 and 24', 'description': 'Blinding effectiveness by asking the Blinded Evaluator which treatment they think the donor sites (A and B) received'}], 'primaryOutcomes': [{'measure': 'Time to Complete Closure', 'timeFrame': 'up to 4 weeks', 'description': 'The primary effectiveness endpoint is time, in days, to complete closure (≥95% epithelialization by blinded assessor) of study donor sites confirmed at two consecutive visits.'}], 'secondaryOutcomes': [{'measure': 'Donor Site Treatment Preference (Site A or Site B) Reported by Subject', 'timeFrame': '4 weeks', 'description': 'Subject will be asked which donor site (A or B) they prefer (if subject is less than 8 years of age parents will be asked)'}, {'measure': 'Donor Site Treatment Preference (Site A or Site B) Reported by Physician', 'timeFrame': '4 weeks', 'description': 'Physician will be asked which donor site (A or B) they prefer'}, {'measure': 'Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment', 'timeFrame': 'Day 7', 'description': 'Comparative Itching of study donor sites during 1st week post treatment by asking which site was itchier after treatment'}, {'measure': 'Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment', 'timeFrame': 'Day 7 or 8', 'description': 'Comparative pain of study donor sites during 1st week post treatment by asking the child which site was more painful since treatment'}, {'measure': 'Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)', 'timeFrame': 'Week 24', 'description': 'Blinded Evaluator Overall Opinion POSAS Score of study donor sites. The Overall Opinion Score uses a 10-point scale where 10 corresponds to the worst imaginable scar.'}, {'measure': 'Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)', 'timeFrame': 'Week 24', 'description': 'Patient Overall Opinion POSAS Score of study donor sites(reported by subject 8 years of age or older, or by parent/guardian if subject less than 8 years of age). The Overall Opinion Score uses a 10-point scale where 10 corresponds to the worst imaginable scar.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Pediatric, Complex Skin Deformities'], 'conditions': ['Skin; Deformity']}, 'descriptionModule': {'briefSummary': 'To evaluate whether the time to complete closure is superior for RECELL-treated split-thickness donor sites, compared with Control (standardized dressings only). The mean time for donor site healing will be compared between treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients aged 1 through 16 years (inclusive) with a skin defect for which autografting is indicated.\n2. The area of total injury or planned defect (excluding donor sites) is 5% to 25% Total Body Surface Area (TBSA), inclusive.\n3. Two discrete donor sites of similar size (± 25%) can be created in a similar non-articulating location (excluding the scalp) with each donor site representing a minimum of 1% TBSA.\n4. The patient and family member/parent/guardian are able to complete all follow-up evaluations required by the study protocol.\n5. In the opinion of the Investigator, the patient and/or parent/guardian must be able to:\n\n 1. Understand the full nature and purpose of the study, including possible risks and adverse events, and\n 2. Provide informed consent/assent as appropriate for study participation.\n6. The patient and/or parent/guardian agrees to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary and comply with all compulsory study procedures.\n7. The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.\n8. The patient and/or parent/guardian can read and understand instructions and give informed, voluntary, written consent.\n9. Life expectancy greater than 52 weeks.\n\nExclusion Criteria:\n\n1. Prior autograft harvest at planned study donor sites.\n2. Patients with sepsis or hemodynamic instability.\n3. The patient has an infection under active management or other dermatologic condition at the planned donor sites or treatment areas.\n4. Patient (of reasonable age) or parent/guardian is unable to follow the protocol requirements.\n5. The patient has other concurrent conditions that in the opinion of the Investigator may compromise patient safety or study objectives.\n6. Patients with a known hypersensitivity to trypsin or compound sodium lactate for irrigation.\n7. In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).\n8. Enrollment in a concurrent study in which the study treatment may confound the endpoints of this study.'}, 'identificationModule': {'nctId': 'NCT03624192', 'briefTitle': 'RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avita Medical'}, 'officialTitle': 'A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RES (Regenerative Epidermal Suspension) Prepared With the RECELL® Device Compared to Conventional Care for Healing of Donor Sites in Infants, Children and Adolescents (Aged 1-16 Years)', 'orgStudyIdInfo': {'id': 'CTP006-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RECELL® Autologous Cell Harvesting Device', 'description': 'RECELL + Telfa™ Clear and Xeroform™ dressings', 'interventionNames': ['Device: RECELL® Autologous Cell Harvesting Device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telfa™ Clear and Xeroform™ dressings', 'description': 'Telfa™ Clear and Xeroform™ dressings', 'interventionNames': ['Other: Telfa™ Clear and Xeroform™ dressings']}], 'interventions': [{'name': 'RECELL® Autologous Cell Harvesting Device', 'type': 'DEVICE', 'otherNames': ['RES (Regenerative Epidermal Suspension)'], 'description': 'Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings', 'armGroupLabels': ['RECELL® Autologous Cell Harvesting Device']}, {'name': 'Telfa™ Clear and Xeroform™ dressings', 'type': 'OTHER', 'otherNames': ['Control'], 'description': 'Telfa™ Clear and Xeroform™ dressings', 'armGroupLabels': ['Telfa™ Clear and Xeroform™ dressings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85008', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Burn Center at Maricopa Intergrated Health Systems', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Shriners Hospital for Children, Northern California', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Shriners Hospital for Children, Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '44308', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': "Akron Children's Hospital", 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Regional Burn Center at Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avita Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biomedical Advanced Research and Development Authority', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}