The objective of this nonrandomized, trial is comparing the treatment effects and complications of the CO2 laser partial nail matricectomy and lateral nail fold excision in 100 patients suffering from ingrowing nail. In this study, patients presented with ingrowing nail and documented by dermatologist were included in study. Patients with Tinea ungium, subungual hyperosteosis, pregnancy and anti-coagulant drugs consumption were excluded from the study.
After taking the written informed consent, demographic and clinical data were recorded in a questionnaire.
In one group of patients,after injection of lidocaine , a strip of nail matrix at involvement site was destroyed by CO2 laser. In another group, lateral nail fold under injection of anesthesia at involvement side was excised surgically.
Patients were monitored before and after the treatment by photography. Patients were followed up for outcome and probable complications at the end of the first week and first month and later every 3 months for 1 year. Finally,the treatment outcomes including cure rate and complications such as infection, persistent pain and recurrence were compared by appropriate statistical test in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604176403N6
Registration date:2017-06-06, 1396/03/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-06, 1396/03/16
Registrant information
Name
Hossein Kavoussi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1837 5424
Email address
hkawosi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research and technology of Kermanshah University of Medical Scienses
Expected recruitment start date
2012-06-23, 1391/04/03
Expected recruitment end date
2014-10-02, 1393/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of CO2 laser partial nail matricectomy and lateral nail fold excision in the treatment of ingrowing nail
Public title
Treatment of ingrowing nail by CO2 lase and lateral nail fold excision
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Clinically documented by dermatologist
Exclusion criteria: Tinea ungium, subungual hyperosteosis, pregnancy and anti-coagulant drugs consumption
Age
From 16 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Scienses
Street address
Shahid Beheshty Blvd
City
Kermanshah
Postal code
Approval date
2014-11-14, 1393/08/23
Ethics committee reference number
35231/420/7/پ
Health conditions studied
1
Description of health condition studied
Ingrowing nail
ICD-10 code
L62*
ICD-10 code description
Nail disorders in diseases classified elsewhere
Primary outcomes
1
Description
Treatment of ingrowing nail
Timepoint
The end of 1th week, 1th, 3th, 6th, 12th months
Method of measurement
clinical observation
Secondary outcomes
1
Description
Infection
Timepoint
The end 1 week, 1th, 3th, 6th and 12th months
Method of measurement
Clinical observation and labratory assesmsnt
2
Description
Persistant pain
Timepoint
The end 1 week, 1th, 3th, 6th and 12th months
Method of measurement
Clinical observation
3
Description
Recurrence
Timepoint
The end 1 week, 1th, 3th, 6th and 12th months
Method of measurement
Clinical observation
4
Description
Nail deformity
Timepoint
The end 1 week, 1th, 3th, 6th and 12th months
Method of measurement
Clinical observation
Intervention groups
1
Description
In one group partial nail matrix destructed by CO2 laser. .
Category
Treatment - Devices
2
Description
In other group lateral nail fold exiced by surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajdaie clinic
Full name of responsible person
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Kermanshah University of Medical Sciences
Full name of responsible person
Dr Behrooz Hamzeh
Street address
Department of Vice Chancellor for reaserch and technology,Shahid Beheshty Blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of 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
ِDr Hossein Kavoussi
Position
Associate Professour
Other areas of specialty/work
Street address
Hajdaie clinic, Golestan Blvd
City
Kermanshah
Postal code
Phone
+98 83 3825 6643
Fax
Email
hkawosi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Ali Ebrahimi
Position
Associate Professour
Other areas of specialty/work
Street address
Hajdaie clinic, Golestan Blvd
City
Kermanshah
Postal code
Phone
+98 83 3427 4622
Fax
Email
aebrahimh@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Kavoussi
Position
Medical Student
Other areas of specialty/work
Street address
Sayyad shirazy street, medical school
City
Kermanshah
Postal code
6714647934
Phone
+98 83 4825 6643
Fax
Email
kavoussi_1383@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)