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

Primary Purpose

Androgenetic Alopecia

Status
Unknown status
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Trichophytic closure upper edge trimming
Trichophytic closure lower edge trimming
Trichophytic closure both edge trimming
Sponsored by
Siriraj Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Trichophytic closure, hair transplantation, donor site, Androgenetic alopecia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

upper edge trimming

lower edge trimming

Both edge trimming

Arm Description

Surgery: trichophytic closure The 1-millimetre trimming of upper edge of linear incision before wound closure

Surgery: trichophytic closure The 1-millimetre trimming of lower edge of linear incision before wound closure

Surgery: trichophytic closure The 0.5-millimetre trimming of both edge of linear incision before wound closure

Outcomes

Primary Outcome Measures

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*

Secondary Outcome Measures

Number of Participants with wound complication
Record number of patient who have wound problem example Hematoma, Wound separation, wound Infection, etc.

Full Information

First Posted
July 17, 2012
Last Updated
August 1, 2012
Sponsor
Siriraj Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01655602
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siriraj Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
Trichophytic closure, hair transplantation, donor site, Androgenetic alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
upper edge trimming
Arm Type
Experimental
Arm Description
Surgery: trichophytic closure The 1-millimetre trimming of upper edge of linear incision before wound closure
Arm Title
lower edge trimming
Arm Type
Experimental
Arm Description
Surgery: trichophytic closure The 1-millimetre trimming of lower edge of linear incision before wound closure
Arm Title
Both edge trimming
Arm Type
Experimental
Arm Description
Surgery: trichophytic closure The 0.5-millimetre trimming of both edge of linear incision before wound closure
Intervention Type
Procedure
Intervention Name(s)
Trichophytic closure upper edge trimming
Other Intervention Name(s)
upper Trichophytic, upper edge trimming
Intervention Description
'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.
Intervention Type
Procedure
Intervention Name(s)
Trichophytic closure lower edge trimming
Other Intervention Name(s)
lower trichophytic closure, lower edge trimming
Intervention Description
'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.
Intervention Type
Procedure
Intervention Name(s)
Trichophytic closure both edge trimming
Other Intervention Name(s)
both edge Trichophytic closure, both edge trimming
Intervention Description
'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.
Primary Outcome Measure Information:
Title
Changing of scar on the donor site during time courses
Description
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*
Time Frame
1 week, 4 week, 12 week, 24 week
Secondary Outcome Measure Information:
Title
Number of Participants with wound complication
Description
Record number of patient who have wound problem example Hematoma, Wound separation, wound Infection, etc.
Time Frame
immediate, 1week, 4week, 12week, 24week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rattapon Thuangtong, MD
Phone
+662-419-4333
Email
rattaponthuangtong@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Saroj Suvanasuthi, MD, PhD
Phone
+662-419-4333
Email
doctorhe@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rattapon Thuangtong, MD
Organizational Affiliation
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rattapon Thuangtong, MD
Phone
+662-419-4333
Email
rattaponthuangtong@yahoo.com
First Name & Middle Initial & Last Name & Degree
Kanchalit Thanomkitti, MD
Phone
+662-419-4333
Email
kanchalitt@hotmail.com

12. IPD Sharing Statement

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

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