Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT00774033
Status:
TERMINATED
Last Update Posted:
2012-07-26
First Post:
2008-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epidermal Cells Delivery and Acute Burns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'whyStopped': 'Not enough patients included', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-25', 'studyFirstSubmitDate': '2008-10-15', 'studyFirstSubmitQcDate': '2008-10-15', 'lastUpdatePostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks.', 'timeFrame': 'at 1, 2 and 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Medical costs at complete epithelialisation', 'timeFrame': 'At 6, 12 and 18 months'}, {'measure': 'Post-operative pain', 'timeFrame': 'At 6 weeks'}, {'measure': 'Medical assessment of scar quality', 'timeFrame': 'at 6 weeks and 6, 12, 18 months'}, {'measure': 'Patient self assessment of scar', 'timeFrame': 'At 6, 12 and 18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Keratinocytes', 'Cell spray', 'Deep partial thickness burns', 'Full thickness burns'], 'conditions': ['Burn']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare results obtained with epidermal cell spray and classic skin grafting for epidermal replacement in acute burns', 'detailedDescription': 'Comparing the impact in terms of cicatrisation duration and costs between 2 treatments of deep 2nd and 3rd degree burns.\n\nDetermine if the costs of the innovating treatment RECELL®, a priori more expensive, are counterbalanced by a shorter cicatrisation duration and an improved evolution versus a conventional strategy.\n\nGive an information about efficiency improvement of RECELL® with additional costs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thermal burns requiring surgical debridement\n* Area involved \\< 1260cm²\n\nExclusion Criteria:\n\n* local or systemic infection\n* conditions that would interfere with wound healing (diabetes, hypertension, inflammatory diseases treated by corticoids)\n* hypersensitivity to trypsin'}, 'identificationModule': {'nctId': 'NCT00774033', 'acronym': 'ENSEM', 'briefTitle': 'Epidermal Cells Delivery and Acute Burns', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'A Randomized Trial Comparing Recell® Autologous Epidermal Cells Harvesting Kits Versus Classic Skin Grafts for the Treatment of Acute Burn in Adults and Children', 'orgStudyIdInfo': {'id': 'P070307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Treatment of acute burn in adults and children by epidermal cell spray', 'interventionNames': ['Device: autologous epidermal cells harvesting kits']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Treatment of acute burn in adults and children by classic skin grafts', 'interventionNames': ['Procedure: classic skin grafts']}], 'interventions': [{'name': 'autologous epidermal cells harvesting kits', 'type': 'DEVICE', 'otherNames': ['Recell®'], 'description': 'autologous epidermal cells harvesting kits used for the treatment of acute burn', 'armGroupLabels': ['1']}, {'name': 'classic skin grafts', 'type': 'PROCEDURE', 'description': 'classic skin grafts used for the treatment of acute burn', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Olivier GALL, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}