Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT01655602
Status:
UNKNOWN
Last Update Posted:
2012-08-02
First Post:
2012-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Split Wound Comparison of Trichophytic Closure Techniques for Donor Site in Hair Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-01', 'studyFirstSubmitDate': '2012-07-17', 'studyFirstSubmitQcDate': '2012-08-01', 'lastUpdatePostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changing of scar on the donor site during time courses', 'timeFrame': '1 week, 4 week, 12 week, 24 week', 'description': "* Hair density\n* Width of scar\n* Global photographic view (taken with Cannon 60D 18.0 Megapixels 100 mm macro lens)\n* Uninvolved dermatologist's assessment \\*\n* Self assessment\\*"}], 'secondaryOutcomes': [{'measure': 'Number of Participants with wound complication', 'timeFrame': 'immediate, 1week, 4week, 12week, 24week', 'description': 'Record number of patient who have wound problem example Hematoma, Wound separation, wound Infection, etc.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Trichophytic closure', 'hair transplantation', 'donor site', 'Androgenetic alopecia'], 'conditions': ['Androgenetic Alopecia']}, 'descriptionModule': {'briefSummary': 'This study aim to compare cosmetic results between 3 trichophytic closure techniques for donor site (the trimming of upper, lower and both edge of linear incision) in hair transplantation.', 'detailedDescription': "Strip harvesting technique, a conventional hair transplantation procedure, is widely used in the treatment of androgenetic alopecia for more than half a century. It provides less time-consuming, more feasible and more cost-effective comparing with follicular unit extraction (FUE) technique. However, linear scar at the donor site is also introduced.\n\nThe latest method to fine the scar at the donor site was invented and known as 'Trichophytic closure technique'. It can be done by trimming upper or lower wound edge for about 1 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique.\n\nThis research is a pilot, split-wound comparison study of trichophytic closure techniques for donor site in hair transplantation.10 males, aged ≥ 25 years, who require strip harvesting follicular unit transplantation in the treatment of androgenetic alopecia will be enrolled. Preoperative and perioperative process will be conducted as standard procedure except wound closure technique. Each incision wound of donor site will be equally divided into 3 parts (marked with tattoos as Fig.2) and each part will be randomly treated with different trichophytic closure techniques as below.\n\n* The 1-millimetre trimming of upper edge of linear incision before wound closure\n* The 1-millimetre trimming of lower edge of linear incision before wound closure\n* The 0.5-millimetre trimming of both edge of linear incision before wound closure For evaluation, we have planned to assess both cosmetic results and side effects as shown in the table. ( Table 1 - image file ) After data collecting process, we have planned to analyze the demographic data, rate of infection and other side effects in a descriptive manner. However, the evaluation for cosmetic results will be analyzed by paired t-test in the same technique at different follow up period and by one-way ANOVA between each technique at the same follow up period."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Age of 25 or more\n* Diagnosis of androgenetic alopecia\n* Do not response to conventional treatment and undergo hair transplantation surgery\n\nExclusion Criteria:\n\n* Have skin lesion at donor site\n* Psychological disturbance including trichotillomania\n* Anti-HIV positive'}, 'identificationModule': {'nctId': 'NCT01655602', 'briefTitle': 'Split Wound Comparison of Trichophytic Closure Techniques for Donor Site in Hair Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Siriraj Hospital'}, 'officialTitle': 'Split Wound Comparison of Trichophytic Closure Techniques for Donor Site in Hair Transplantation', 'orgStudyIdInfo': {'id': 'SirirajH-005'}, 'secondaryIdInfos': [{'id': '825/2554EC3', 'type': 'OTHER', 'domain': 'SIRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'upper edge trimming', 'description': 'Surgery: trichophytic closure The 1-millimetre trimming of upper edge of linear incision before wound closure', 'interventionNames': ['Procedure: Trichophytic closure upper edge trimming']}, {'type': 'EXPERIMENTAL', 'label': 'lower edge trimming', 'description': 'Surgery: trichophytic closure The 1-millimetre trimming of lower edge of linear incision before wound closure', 'interventionNames': ['Procedure: Trichophytic closure lower edge trimming']}, {'type': 'EXPERIMENTAL', 'label': 'Both edge trimming', 'description': 'Surgery: trichophytic closure The 0.5-millimetre trimming of both edge of linear incision before wound closure', 'interventionNames': ['Procedure: Trichophytic closure both edge trimming']}], 'interventions': [{'name': 'Trichophytic closure upper edge trimming', 'type': 'PROCEDURE', 'otherNames': ['upper Trichophytic', 'upper edge trimming'], 'description': "'Trichophytic closure technique' can be done by trimming upper or lower wound edge for about 1 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique.", 'armGroupLabels': ['upper edge trimming']}, {'name': 'Trichophytic closure lower edge trimming', 'type': 'PROCEDURE', 'otherNames': ['lower trichophytic closure', 'lower edge trimming'], 'description': "'Trichophytic closure technique' can be done by trimming upper or lower wound edge for about 1 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique.", 'armGroupLabels': ['lower edge trimming']}, {'name': 'Trichophytic closure both edge trimming', 'type': 'PROCEDURE', 'otherNames': ['both edge Trichophytic closure', 'both edge trimming'], 'description': "'Trichophytic closure technique' can be done by trimming upper and lower wound edge for about 0.5 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique.", 'armGroupLabels': ['Both edge trimming']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Rattapon Thuangtong, MD', 'role': 'CONTACT', 'email': 'rattaponthuangtong@yahoo.com', 'phone': '+662-419-4333'}, {'name': 'Kanchalit Thanomkitti, MD', 'role': 'CONTACT', 'email': 'kanchalitt@hotmail.com', 'phone': '+662-419-4333'}], 'facility': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Rattapon Thuangtong, MD', 'role': 'CONTACT', 'email': 'rattaponthuangtong@yahoo.com', 'phone': '+662-419-4333'}, {'name': 'Saroj Suvanasuthi, MD, PhD', 'role': 'CONTACT', 'email': 'doctorhe@gmail.com', 'phone': '+662-419-4333'}], 'overallOfficials': [{'name': 'Rattapon Thuangtong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siriraj Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rattapon Thuangtong', 'investigatorAffiliation': 'Siriraj Hospital'}}}}