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

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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