To evaluate the definitive treatment of onychogryphosis without damaging the matrix and preserving the nail unit.
Design
This study was conducted on patients who were diagnosed with onychogryphosis by a dermatologist and had been referred to the dermatology clinic during the period from 2013 to 2019 and were candidated for reform nail unit surgery.
Settings and conduct
This study was designed as an interventional with no control group and the operation was done at the Dermatology Clinic of Rasoul-e-Akram Hospital (outpatient operating room). After taking necessary tests and scheduling surgery time, patients were referred for surgery. After radiologic studies of involved great toe to exclude exostosis, Surgery performed on patients. The new technique was designed for onychogryphotic toe nail by combination of partial nail matrix phenolization, nail bed widening by longitudinal cuts in the nail bed,onycholysis treatment and displacing the nail matrix and nail bed to opposite direction of nail deviation.
Participants/Inclusion and exclusion criteria
Individuals with onychogryphosis who have not responded to conservative treatments are included in the study.
Patients with peripheral vascular disorders or uncontrolled diabetes were excluded from the current study.
.
Intervention groups
After radiologic studies of involved great toe to exclude exostosis, Surgery performed on patients who do not respond to conservative treatments and complain of pain and inability to nail trimming.
Main outcome variables
At 6, 12 and 18 months postoperatively, the following evaluations were performed: thickness of new nail plate and axis deviation was measured by caliper
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150529022468N4
Registration date:2018-02-20, 1396/12/01
Registration timing:registered_while_recruiting
Last update:2018-02-20, 1396/12/01
Update count:0
Registration date
2018-02-20, 1396/12/01
Registrant information
Name
Mohammadreza Ghassemi
Name of organization / entity
Iran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 2040
Email address
ghassemi.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rasool-e-akram hospital
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and outcome of new surgical and chemical techniques in treatment of onychogryphosis according to thickness and axis of the new nail
Public title
A new technique for management of onychogryphosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of onychogryphosis
No response to conservative treament
Exclusion criteria:
Peripheral blood disorder
Not controlles Diabetes mellitus
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
considering the lack of similar study and very low incidence of this disease, the study was designed as pilot study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic’s committee of Iran university of medical science
Street address
Shahid Hemmat Highway .Tehran.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-05-01, 1396/02/11
Ethics committee reference number
IR.IUMS.REC 1395.95-04-204-29968
Health conditions studied
1
Description of health condition studied
onychogryphosis
ICD-10 code
L60.2
ICD-10 code description
Onychogryphosis
Primary outcomes
1
Description
Nail deviation from longitudinal axis
Timepoint
before intervenyion, 6, 12 and 18 months following end of treatment
Method of measurement
millimetre
Secondary outcomes
1
Description
Nail plate thickness
Timepoint
Before intervention, 6, 12 and 18 months following end of treatment
Method of measurement
Millimetre
Intervention groups
1
Description
combination of partial nail matrix phenolization, nail bed widening by longitudinal cuts in the nail bed,onycholysis treatment and displacing the nail matrix and nail bed to opposite direction of nail deviation.
Vice chancellor of research, Iran university of medical sciences
Full name of responsible person
Mehrdad sheykhvatan
Street address
Hazrat-e Rasool General Hospital, Niyayesh St., Satarkhan St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 4001
Email
Ghassemi.mr@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research, Iran university of medical sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran university of medical sciences
Full name of responsible person
Mohammadreza ghassemi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Street address
Rasool-e-akram hospital
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2421
Fax
Email
Mohammadreza.ghassemi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran university of medical sciences
Full name of responsible person
Mohammadreza ghassemi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2421
Fax
Email
Mohammadreza.ghassemi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran university of medical sciences
Full name of responsible person
Mohammadreza ghassemi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2421
Fax
Email
Mohammadreza.ghassemi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
IPD collected for the last outcome measure only
When the data will become available and for how long
Starting 2 years after publication
To whom data/document is available
Only available for people working in academic institutions
Under which criteria data/document could be used
People who want to do research on the treatment of these types of patients will be able to obtain more information through a referral to the coresponder of the article