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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Siriraj Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Rattapon Thuangtong, Siriraj Hospital
ClinicalTrials.gov Identifier:
NCT01655602
First received: July 17, 2012
Last updated: August 1, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Androgenetic Alopecia
Procedure: Trichophytic closure upper edge trimming
Procedure: Trichophytic closure lower edge trimming
Procedure: Trichophytic closure both edge trimming
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Split Wound Comparison of Trichophytic Closure Techniques for Donor Site in Hair Transplantation

Resource links provided by NLM:


Further study details as provided by Siriraj Hospital:

Primary Outcome Measures:
  • Changing of scar on the donor site during time courses [ Time Frame: 1 week, 4 week, 12 week, 24 week ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: immediate, 1week, 4week, 12week, 24week ] [ Designated as safety issue: Yes ]
    Record number of patient who have wound problem example Hematoma, Wound separation, wound Infection, etc.


Estimated Enrollment: 10
Study Start Date: July 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655602

Contacts
Contact: Rattapon Thuangtong, MD +662-419-4333 rattaponthuangtong@yahoo.com
Contact: Saroj Suvanasuthi, MD, PhD +662-419-4333 doctorhe@gmail.com

Locations
Thailand
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Rattapon Thuangtong, MD    +662-419-4333    rattaponthuangtong@yahoo.com   
Contact: Kanchalit Thanomkitti, MD    +662-419-4333    kanchalitt@hotmail.com   
Sponsors and Collaborators
Siriraj Hospital
Investigators
Principal Investigator: Rattapon Thuangtong, MD Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
  More Information

Additional Information:
No publications provided

Responsible Party: Rattapon Thuangtong, Assistant Professor, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT01655602     History of Changes
Other Study ID Numbers: SirirajH-005, 825/2554EC3
Study First Received: July 17, 2012
Last Updated: August 1, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Siriraj Hospital:
Trichophytic closure
hair transplantation
donor site
Androgenetic alopecia

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 31, 2014