Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-24 @ 8:26 AM
Study NCT ID:
NCT03162367
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2017-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Burn
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2017-05-18', 'studyFirstSubmitQcDate': '2017-05-19', 'lastUpdatePostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in re-epithelization rate with autologous epidermal cell suspension graft from Baseline', 'timeFrame': 'up to 20 days', 'description': 'Measurement the percentage of re-epithelization ( 0-30%=poor; 30-60%=moderate; 60-90%=good; \\>90%=complete)'}, {'measure': 'Change in re-epithelization rate with silver sulfadiazine ointment from Baseline', 'timeFrame': 'up to 20 days', 'description': 'Measure percentage of re-epithelization ( 0-30%=poor; 30-60%=moderate; 60-90%=good; \\>90%=complete)'}], 'secondaryOutcomes': [{'measure': 'Scar formation', 'timeFrame': 'After 2 month', 'description': 'Observe patient and take photo'}, {'measure': 'Post inflammatory hyperpigmentation', 'timeFrame': 'After 2 month', 'description': 'Observe patient and take photo'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Burn', 'Epidermal cell suspension'], 'conditions': ['Burn']}, 'referencesModule': {'references': [{'pmid': '24616577', 'type': 'RESULT', 'citation': 'You HJ, Han SK. Cell therapy for wound healing. J Korean Med Sci. 2014 Mar;29(3):311-9. doi: 10.3346/jkms.2014.29.3.311. Epub 2014 Feb 27.'}, {'pmid': '26706649', 'type': 'RESULT', 'citation': 'Zhao H, Chen Y, Zhang C, Fu X. Autologous epidermal cell suspension: A promising treatment for chronic wounds. J Tissue Viability. 2016 Feb;25(1):50-6. doi: 10.1016/j.jtv.2015.11.003. Epub 2015 Dec 8.'}, {'pmid': '25426401', 'type': 'RESULT', 'citation': 'Mcheik JN, Barrault C, Levard G, Morel F, Bernard FX, Lecron JC. Epidermal healing in burns: autologous keratinocyte transplantation as a standard procedure: update and perspective. Plast Reconstr Surg Glob Open. 2014 Oct 7;2(9):e218. doi: 10.1097/GOX.0000000000000176. eCollection 2014 Sep.'}, {'pmid': '26419871', 'type': 'RESULT', 'citation': 'Gardien KL, Marck RE, Bloemen MC, Waaijman T, Gibbs S, Ulrich MM, Middelkoop E; Dutch Outback Study Group1. Outcome of Burns Treated With Autologous Cultured Proliferating Epidermal Cells: A Prospective Randomized Multicenter Intrapatient Comparative Trial. Cell Transplant. 2016;25(3):437-48. doi: 10.3727/096368915X689569. Epub 2015 Sep 28.'}]}, 'descriptionModule': {'briefSummary': 'Different medical treatments are available for treatment of skin burns such as skin grafts and silver sulfadiazine ointment. These treatments are used for second degree burn as routine technique in burns units. Cell therapy is a new approach for treatment of skin disease.In this study we use autologous epidermal cell suspension to achieve better cosmetic and functional results in treatment of second degree burn.', 'detailedDescription': 'In this study 20 patients in Burn Department of Sina Hospital Tabriz, with at least 2 areas of second degree burn randomly choose. First skin samples are taken from normal skin by 4mm punch and send to the laboratory for preparation of epidermal cell suspension and this suspension is transferred to the one area of second degree burn in each patient and the other area in the same patient dresses by silver sulfadiazine ointment. The dressing changes are followed up for 12h for first assessment of therapy until 10th day after intervention. In the days of 5, 10, 15 and 20 the percentage of re-epithelization for each treatment will be measured. After 2 months, patients are visited and any complications check for scar formation, pain, post inflammatory hyper-pigmentation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy patient with second degree burn admitted in burn unit\n\nExclusion Criteria:\n\n* Pregnancy-lactation\n* Immunosuppression like receiving chemotherapy or radiotherapy\n* Patient unsatisfied to going on study'}, 'identificationModule': {'nctId': 'NCT03162367', 'briefTitle': 'Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Burn', 'organization': {'class': 'OTHER_GOV', 'fullName': 'SCARM Institute, Tabriz, Iran'}, 'officialTitle': 'Comparison Study OF Efficacy Of Autologous Epidermal Cell Suspension And Silver Sulfadiazine Ointment In Second Degree Burn', 'orgStudyIdInfo': {'id': 'SCARM-Skin-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autologous epidermal cell suspension group', 'interventionNames': ['Biological: Autologous epidermal cell suspension']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Silver sulfadiazine ointment group', 'interventionNames': ['Drug: Silver sulfadiazine ointment']}], 'interventions': [{'name': 'Autologous epidermal cell suspension', 'type': 'BIOLOGICAL', 'description': 'First skin samples taken from normal skin by 4mm punch will be send to laboratory for preparation of epidermal cell suspension and this suspension transfer to one area of second degree burn', 'armGroupLabels': ['Autologous epidermal cell suspension group']}, {'name': 'Silver sulfadiazine ointment', 'type': 'DRUG', 'description': 'the area with second degree burn dresses by silver sulfadiazine ointment and dressing change each 12 hour till 10 day', 'armGroupLabels': ['Silver sulfadiazine ointment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tabriz', 'country': 'Iran', 'facility': 'Sina hospital', 'geoPoint': {'lat': 38.08, 'lon': 46.2919}}], 'overallOfficials': [{'name': 'Mohamad Reza Ranjkesh, MD, Dermatologist', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SCARM institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SCARM Institute, Tabriz, Iran', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}