Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-30 @ 10:10 AM
Study NCT ID:
NCT06549569
Status:
COMPLETED
Last Update Posted:
2024-08-12
First Post:
2024-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Burn Coverage of Burn by Tilapia Fish Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tilapia Fish Skin Coverage in Acute Thermal Burn', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tilapia Fish Skin in Burn Coverage']}, 'descriptionModule': {'briefSummary': 'The goal of this experimental study is to compare TFS and regular dressings as coverage for acute thermal burns. The main question it aims to answer is:\n\nIs TFS effective in treating thermal burns? burn induction was done on rabbits to obtain second-degree thermal burn, followed by coverage with TFS', 'detailedDescription': 'Nile Tilapia Fish Skin (NTFS) has been suggested as an option for biological material for the management of burns. Nile Tilapia Fish Skin also presented a large composition of type I collagen, morphology similar to human skin and high resistance and tensile extension at the break. We chose Baladi rabbits for their relatively ease of handling, accommodation and resistance to surgical aggressions and infectious processes, with low mortality. However, the choice of male rabbits is due to variations in hormonal cycles in females that could intervene in the process of tissue repair.\n\nThis experimental model was established to evaluate healing process and outcome results after application of Tilapia Fish Skin on acute contact thermal that was done in order to obtain injuries with the same size and depth.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'animal rabbits', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- healthy male one year old rabbit\n\nExclusion Criteria:\n\n* female unhealthy rabbits'}, 'identificationModule': {'nctId': 'NCT06549569', 'acronym': 'TFS', 'briefTitle': 'Burn Coverage of Burn by Tilapia Fish Skin', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University'}, 'officialTitle': 'Tilapia Fish Skin Coverage in Acute Thermal Burn; Experimental and Histopathological Study', 'orgStudyIdInfo': {'id': '696/11/22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TFS', 'description': 'thermal burn coverage with Tilapia fish skin', 'interventionNames': ['Procedure: TFS']}, {'label': 'regular dressing', 'description': 'thermal burn coverage with regular dressing', 'interventionNames': ['Procedure: TFS']}], 'interventions': [{'name': 'TFS', 'type': 'PROCEDURE', 'description': 'burn coverage with TFS', 'armGroupLabels': ['TFS', 'regular dressing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aswān', 'country': 'Egypt', 'facility': 'Amira Anter', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident', 'investigatorFullName': 'Amira Anter', 'investigatorAffiliation': 'Aswan University'}}}}