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UnknownNCT01655602

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

Status
Unknown
Phase
Phase 1
Study type
Interventional
Enrollment
10 (estimated)
Sponsor
Siriraj Hospital · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETrichophytic 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.
PROCEDURETrichophytic 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.
PROCEDURETrichophytic 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.

Timeline

Start date
2012-07-01
Primary completion
2013-03-01
Completion
2013-05-01
First posted
2012-08-02
Last updated
2012-08-02

Locations

1 site across 1 country: Thailand

Source: ClinicalTrials.gov record NCT01655602. Inclusion in this directory is not an endorsement.