Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-02-18 @ 1:07 AM
Study NCT ID:
NCT03312803
Status:
COMPLETED
Last Update Posted:
2022-04-20
First Post:
2017-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mini-autogenous Skin Grafts With Skin Homografts Versus Autogenous Skin Graft for Covering Post Burn Wounds in Children
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-18', 'studyFirstSubmitDate': '2017-09-13', 'studyFirstSubmitQcDate': '2017-10-16', 'lastUpdatePostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The major outcome is to specify if the regular single piece autogenous skin graft is better than the new technique that uses small pieces mini autogenous skin grafts for treatment of post burn wounds in children. or vice versa?', 'timeFrame': '2 years', 'description': 'the spread of the small pieced autogenous skin grafts that are covered with homogenous skin graft over post burn wounds in children may give better results than the regular single pieced autogenous skin graft'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burns']}, 'descriptionModule': {'briefSummary': 'A prospective study comparing the use of mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children.', 'detailedDescription': 'A prospective study comparing the use of mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children so that the patient can continue on his/her normal life early with less deformities'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* This study will include children (3-12) years old with (10-30) % body surface area burns, admitted to Assuit university hospital burn unit.\n* The raw areas in both upper and lower limbs will be the site of the study.\n\nExclusion Criteria:\n\n* Patients younger than 3 years old.\n* Patients with burns more than 30% of total body surface area.\n* Patients with medical or mental diseases.'}, 'identificationModule': {'nctId': 'NCT03312803', 'briefTitle': 'Mini-autogenous Skin Grafts With Skin Homografts Versus Autogenous Skin Graft for Covering Post Burn Wounds in Children', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Mini-autogenous Skin Grafts With Skin Homografts Versus Autogenous Skin Graft for Covering Post Burn Wounds in Children', 'orgStudyIdInfo': {'id': 'Assiut'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mini autogenous skin grafts', 'description': 'we take the autogenous skin graft from the same patient then cut it into small pieces then we spread it over the burn wound on one limb then cover these small pieces with homogenous skin graft taken from another person.', 'interventionNames': ['Procedure: Mini autogenous skin graft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Autogenous skin graft', 'description': 'we take the regular autogenous one piece skin graft from the same patient and cover the burn wound on the other limb then we make a comparison between both limbs', 'interventionNames': ['Procedure: Mini autogenous skin graft']}], 'interventions': [{'name': 'Mini autogenous skin graft', 'type': 'PROCEDURE', 'description': 'mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children.', 'armGroupLabels': ['Autogenous skin graft', 'Mini autogenous skin grafts']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University Faculty of medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Mohamed St Salah El Din, Resident', 'role': 'STUDY_CHAIR', 'affiliation': 'Doctor Mostafa El Sonbaty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Plan to do the study then share this study to be useful for all Plastic surgeons all around the world'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Mohamed Salah El Din Mohamed Hassan', 'investigatorAffiliation': 'Assiut University'}}}}