The objective of this nonrandomized, trial study is to investigate the outcome of suction blistering epidermal graft by means of a motor- driven dental lab finishing carbide bur for preparation of the recipient site in depigmented lesions. In this study, 14 patients with 45 stable depigmented lesions who met the inclusion criteria were recruited and subjected to this procedure. Firstly anterolateral of leg was anesthetized as a donor site, we used three- way connected double syringes or funnel cylinder technique for harvesting of epidermal grafts. Later depigmented epidermis was removed by a motor- driven dermabrader, using a cylindrical, round end, titanium nitride- coated carbide bur and finally harvested epidermis placed over the abraded recipient site. Patients were monitored before and after treatment by photography. Patients were followed-up for improvement that was the rate of repigmentation and probable complications such as: scar formation, color mismatch and peri graft halo.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138802251906N1
Registration date:2011-11-19, 1390/08/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-19, 1390/08/28
Registrant information
Name
Ali Ebrahimi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1823 3862
Email address
aebrahimi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2006-10-10, 1385/07/18
Expected recruitment end date
2011-06-10, 1390/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Outcome of suction blistering epidermal graft by means of a new fraise for preparation of recipient site in depigmented lesions
Public title
Epidermal graft in stable vitiligo
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: depigmented lesions unresponsive to medications and phototherapy; all patients had stable disease for more than 1 year and there was not any history of a positive Kobner phenomenon.
Exclusion criteria: unstable or active vitiligo; positve Kobner phenomenon; age under 12 years old and pregnancy.
Age
From 16 years old to 29 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah university of medical science ethics committee
Street address
Shahid Beheshti blv.
City
kermanshah
Postal code
6714673156
Approval date
2006-05-03, 1385/02/13
Ethics committee reference number
6344/420/7/پ
Health conditions studied
1
Description of health condition studied
Vitiligo and other depigmented lesions
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Repigmentation rate
Timepoint
Every week in the first month and once a month for the following 6-8 months.
Method of measurement
The repigmentation rate of lesions was classified as excellent (more than 75% repigmentation), good (50-75% repigmentation), moderate (25-50% repigmentation) and poor (less than 25% repigmentation).
Secondary outcomes
1
Description
Perigraft halo
Timepoint
All patients were visited every week in the first month and once a month for the following 6-8 months.
Method of measurement
clinical observation
2
Description
Scar and Keloid
Timepoint
All patients were visited every week in the first month and once a month for the following 6-8 months.
Method of measurement
clinical observation
3
Description
Kobner phenomen
Timepoint
All patients were visited every week in the first month and once a month for the following 6-8 months.
Method of measurement
clinical observation
4
Description
Color mismatch
Timepoint
All patients were visited every week in the first month and once a month for the following 6-8 months.
Method of measurement
clinical observation
5
Description
Infection
Timepoint
All patients were visited every week in the first month and once a month for the following 6-8 months.
Method of measurement
clinical observation and Labratory assesment
Intervention groups
1
Description
suction blistering epidermal graft by means of a new dental lab finishing carbide bur for preparation of the recipient site in depigmented lesions.
There was not control group.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajdaie dermatology clinic
Full name of responsible person
Ali Ebrahimi
Street address
Hajdaie clinic Golestan Blvd
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr farid Najafi
Street address
Shahid Beheshti Blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ali Ebrahimi
Position
Assistant professor (dermatologist)
Other areas of specialty/work
Street address
Hajdaie clinic, Golestan Blvd
City
Kermanshah
Postal code
67146-53113
Phone
+98 83 1835 9054
Fax
Email
aebrahimi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Dermatology,School of medicine,University of medical science
Full name of responsible person
Dr Hossein Kavoussi
Position
Assistant Professor
Other areas of specialty/work
Street address
Golestan sq.
City
Kermanshah
Postal code
6714637519
Phone
+98 83 1837 5424
Fax
+98 83 2427 4623
Email
hkawosi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Dermatology,School of medicine,University of medical science
Full name of responsible person
Hossein Kavoussi
Position
Assistant Professor
Other areas of specialty/work
Street address
Hajdaie clinic, Golestan Blvd
City
Kermanshah
Postal code
6714637519
Phone
+98 83 1837 5424
Fax
+98 83 1427 4623
Email
hkawosi@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)