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

NCT ID: NCT01655602

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Androgenetic Alopecia

Keywords

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Trichophytic closure hair transplantation donor site Androgenetic alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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upper edge trimming

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

Group Type EXPERIMENTAL

Trichophytic closure upper edge trimming

Intervention Type PROCEDURE

'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.

lower edge trimming

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

Group Type EXPERIMENTAL

Trichophytic closure lower edge trimming

Intervention Type PROCEDURE

'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.

Both edge trimming

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

Group Type EXPERIMENTAL

Trichophytic closure both edge trimming

Intervention Type PROCEDURE

'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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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upper Trichophytic upper edge trimming lower trichophytic closure lower edge trimming both edge Trichophytic closure both edge trimming

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Siriraj Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rattapon Thuangtong

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rattapon Thuangtong, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Rattapon Thuangtong, MD

Role: CONTACT

Phone: +662-419-4333

Email: [email protected]

Saroj Suvanasuthi, MD, PhD

Role: CONTACT

Phone: +662-419-4333

Email: [email protected]

Facility Contacts

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Rattapon Thuangtong, MD

Role: primary

Kanchalit Thanomkitti, MD

Role: backup

Other Identifiers

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825/2554EC3

Identifier Type: OTHER

Identifier Source: secondary_id

SirirajH-005

Identifier Type: -

Identifier Source: org_study_id