Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:35 AM
Study NCT ID:
NCT06488612
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Use of Minced Skin Grafts for Promoting Donor Site Wound Healing After Split-Thickness Skin Grafting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-06', 'releaseDate': '2025-07-14'}], 'estimatedResultsFirstSubmitDate': '2025-07-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-07-03', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scar quality', 'timeFrame': 'Follow up at 1 month, 3 months, 6 months', 'description': "using POSAS scale.\n\n• Patient Observer Scar Assesment Scale (POSAS) is a validated scale that measures scar quality by evaluating visual, tactile, and sensory characteristics of the scar from two different perspectives: the patient perspective and the surgeons' perspective."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Split- thickness Skin grafting'], 'conditions': ['Traumatic Skin Loss, 2nd and 3rd Degree Burn, Post Tumour Excision - Raw Areas Undergoes Split- Thickness Skin Grafts']}, 'descriptionModule': {'briefSummary': 'Split-thickness skin grafting (STSG) is one of the most commonly performed procedures to achieve wound closure. Most studies are concerned on improving the appearance of scars and shortening the healing time of the recipient sites. However, the management of the donor site usually takes a second consideration.\n\nThere is a lack of consensus on the recommended method of donor site management. Donor site morbidity of STSG is usually minimal, but that may not always be the case. Morbidity may include pigmentary abnormalities, prolonged pain and itching, delayed healing, or unfavorable scarring. So, an effort must be taken to find the optimal solution for donor site healing and minimize morbidity.\n\nSmall portions of the skin graft left at the end of the procedure or the graft pieces obtained after trimming the edges are usually discarded. There have been some studies demonstrating the benefit of the minced residual skin graft on the donor site, possibly resulting in earlier epithelialization and improving the appearance', 'detailedDescription': 'The aim of this study is to compare the duration of wound healing, scar quality and cosmetic results of donor sites after split-thickness skin grafting with and without the use of residual graft pieces as minced skin grafts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing split-thickness skin grafting, between 12 - 60 years of age.\n\nExclusion Criteria:\n\n* Patients under the age of 12 years or above 60 years.\n* Patients with a known tendency for hypertrophic scarring/keloids\n* Pregnancy\n* Co-morbid factors such as uncontrolled diabetes, ischemic heart disease, renal failure or Collagen vascular disease.'}, 'identificationModule': {'nctId': 'NCT06488612', 'briefTitle': 'Evaluation of the Use of Minced Skin Grafts for Promoting Donor Site Wound Healing After Split-Thickness Skin Grafting', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Evaluation of the Use of Minced Skin Grafts for Promoting Donor Site Wound Healing After Split-Thickness Skin Grafting: A Prospective Half-side Comparative Study', 'orgStudyIdInfo': {'id': 'Soh-Med-24-02-09MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cases', 'description': 'A Prospective Half-side Comparative Study, Minced skin grafts will be used on a half of donor site of the same patient', 'interventionNames': ['Procedure: Minced skin grafts for donor site']}], 'interventions': [{'name': 'Minced skin grafts for donor site', 'type': 'PROCEDURE', 'description': "After harvesting of STSG using watson's knife and coverage of the recipient site, the excess graft edges will be trimmed and together with any unused graft pieces will be collected in saline filled plate to prevent graft dissecation. Graft pieces will be placed over a rigid surface such as dorsum of a stainless steal jar or pot. Mincing of these small grafts will be done manually using large blade (no. 25) and sharp scissors. The resulting pasty graft mass composed of a large number of minced skin graft particles and a small amount of saline solution will be spread onto one half of the donor site using small dressing forceps.\n\nMinced skin grafts will not be used on the other half (control side). The entire donor site will be covered with non-adherent absorbable dressing in the form of Vaseline gauze and sterilized cotton-filled dressing followed by elastic compression bandage.", 'armGroupLabels': ['Cases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02093', 'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Abd El-Mawla Mohamed, Resident plastic surgeon', 'role': 'CONTACT', 'email': 'mohamed_abdelmageed@med.sohag.edu.eg', 'phone': '+0201221953861'}, {'name': 'Gamal Yousef Elsayed, Professor of plastic surgery', 'role': 'CONTACT', 'phone': '+20 115 6996929'}], 'facility': 'Plastic surgery department, Faculty of medicine, Sohag university', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Mohamed Abd Elmawla Mohamed, Resident plastic surgeon', 'role': 'CONTACT', 'email': 'mohamed_abdelmageed@med.sohag.edu.eg', 'phone': '+0201221953861'}, {'name': 'Gamal Yousef Elsayed, Professor of plastic surgery', 'role': 'CONTACT', 'phone': '+20 115 6996929'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'December 2023 to December 2024', 'ipdSharing': 'YES', 'description': 'Final results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Mohamed Abdelmawla Mohamed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-07-14', 'type': 'RELEASE'}, {'date': '2025-08-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mohamed Abdelmawla Mohamed, principal investigator, Sohag University'}}}}