Brief Title
Split Wound Comparison of Trichophytic Closure Techniques for Donor Site in Hair Transplantation
Official Title
Split Wound Comparison of Trichophytic Closure Techniques for Donor Site in Hair Transplantation
Brief Summary
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.
Detailed Description
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. The 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. This 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. - The 1-millimetre trimming of upper edge of linear incision before wound closure - The 1-millimetre trimming of lower edge of linear incision before wound closure - 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Changing of scar on the donor site during time courses
Secondary Outcome
Number of Participants with wound complication
Condition
Androgenetic Alopecia
Intervention
Trichophytic closure upper edge trimming
Study Arms / Comparison Groups
upper edge trimming
Description: Surgery: trichophytic closure The 1-millimetre trimming of upper edge of linear incision before wound closure
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
10
Start Date
July 2012
Completion Date
May 2013
Primary Completion Date
March 2013
Eligibility Criteria
Inclusion Criteria: - Male - Age of 25 or more - Diagnosis of androgenetic alopecia - Do not response to conventional treatment and undergo hair transplantation surgery Exclusion Criteria: - Have skin lesion at donor site - Psychological disturbance including trichotillomania - Anti-HIV positive
Gender
Male
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Rattapon Thuangtong, MD, +662-419-4333, [email protected]
Location Countries
Thailand
Location Countries
Thailand
Administrative Informations
NCT ID
NCT01655602
Organization ID
SirirajH-005
Secondary IDs
825/2554EC3
Responsible Party
Principal Investigator
Study Sponsor
Siriraj Hospital
Study Sponsor
Rattapon Thuangtong, MD, Principal Investigator, Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Verification Date
July 2012