Split Wound Comparison of Trichophytic Closure Techniques for Donor Site in Hair Transplantation

Androgenetic Alopecia Clinical Trial

Official title:

Split Wound Comparison of Trichophytic Closure Techniques for Donor Site in Hair Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01655602
• Other study ID #: SirirajH-005
• Secondary ID: 825/2554EC3
• Status: Recruiting
• Phase: Phase 1
• First received: July 17, 2012
• Last updated: August 1, 2012
• Start date: July 2012
• Est. completion date: May 2013

Study information

• Verified date: July 2012
• Source: Siriraj Hospital
• Contact: Rattapon Thuangtong, MD
• Phone: +662-419-4333
• Email: rattaponthuangtong[@]yahoo.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Androgenetic Alopecia

Intervention

Procedure:
• Trichophytic closure upper edge trimming
'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.
• Trichophytic closure lower edge trimming
'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.
• Trichophytic closure both edge trimming
'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.

Locations

Country	Name	City	State
Thailand	Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changing of scar on the donor site during time courses	Hair density; Width of scar; Global photographic view (taken with Cannon 60D 18.0 Megapixels 100 mm macro lens); Uninvolved dermatologist's assessment *; Self assessment*	1 week, 4 week, 12 week, 24 week	No
Secondary	Number of Participants with wound complication	Record number of patient who have wound problem example Hematoma, Wound separation, wound Infection, etc.	immediate, 1week, 4week, 12week, 24week	Yes

External Links

•   Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University