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

August 1, 2012 updated by: Rattapon Thuangtong, Siriraj Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: upper edge trimming
Surgery: trichophytic closure The 1-millimetre trimming of upper edge of linear incision before wound closure
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.
Other Names:
  • upper Trichophytic
  • upper edge trimming
EXPERIMENTAL: lower edge trimming
Surgery: trichophytic closure The 1-millimetre trimming of lower edge of linear incision before wound closure
Procedure: 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.
Other Names:
  • lower trichophytic closure
  • lower edge trimming
EXPERIMENTAL: Both edge trimming
Surgery: trichophytic closure The 0.5-millimetre trimming of both edge of linear incision before wound closure
Procedure: 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.
Other Names:
  • both edge Trichophytic closure
  • both edge trimming

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing of scar on the donor site during time courses
Time Frame: 1 week, 4 week, 12 week, 24 week
  • 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with wound complication
Time Frame: immediate, 1week, 4week, 12week, 24week
Record number of patient who have wound problem example Hematoma, Wound separation, wound Infection, etc.
immediate, 1week, 4week, 12week, 24week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ANTICIPATED)

March 1, 2013

Study Completion (ANTICIPATED)

May 1, 2013

Study Registration Dates

First Submitted

July 17, 2012

First Submitted That Met QC Criteria

August 1, 2012

First Posted (ESTIMATE)

August 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 2, 2012

Last Update Submitted That Met QC Criteria

August 1, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SirirajH-005
  • 825/2554EC3 (OTHER: SIRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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