Clinical trial NCT01655602: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Androgenetic Alopecia
Keywords: Trichophytic closure
hair transplantation
donor site
Androgenetic alopecia
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2012-08-02
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changing of scar on the donor site during time courses
timeFrame: 1 week, 4 week, 12 week, 24 week
Secondary outcomes:
measure: Number of Participants with wound complication
timeFrame: immediate, 1week, 4week, 12week, 24week
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Rattapon Thuangtong, MD
role: PRINCIPAL_INVESTIGATOR
References: