Comprehensive Analysis of Effectiveness and Complications of Lateral Matricectomy With Phenol 90%, TCA 100% & RF in Patients With Ingrown Toenail
Design
Three Parallel Group Randomized Clinical Trail With Blinded Outcome Assessment, Randomization Will be Conducted Using a Table of Random Numbers. Number of Patients Will be 12 and These Patients Will Be Followed For Six Months.
Settings and conduct
The Patients With Ingrown Toenail Who Are Volunteer to Participate in the Research Will Be Surgically Operated on in the Dermatology Clinic of Rasool Akram Hospital of Tehran. Each of the Patients Will Randomly Receive One of the Lateral Matricectomy Treatment Methods With Phenol 90%, TCA 100% or Radio Frequency. Since This Study Is a Single-Blind, Patients Will Be Unaware of the Details of the Method Used For Their Treatment.
Participants/Inclusion and exclusion criteria
Patients With Grades 2 and 3 Ingrown Toenail
Intervention groups
lateral Matricectomy With Phenol 90%, TCA 100% & RF
Main outcome variables
Treatment Modality; Post Surgery Infection; Post Surgery Drainage; Recurrence; Cosmetic Effect; Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220228054152N1
Registration date:2023-01-03, 1401/10/13
Registration timing:retrospective
Last update:2023-01-03, 1401/10/13
Update count:0
Registration date
2023-01-03, 1401/10/13
Registrant information
Name
Zahra Keshavarz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3731 1221
Email address
s.zahrakeshavarz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comprehensive Analysis of Effectiveness and Complications of Lateral Matricectomy With Phenol 90%, TCA 100% & RF in Patients With Ingrown Toenail
Public title
Comprehensive Analysis of Effectiveness and Complications of Lateral Matricectomy in Patients With Ingrown Toenail
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients With Ingrown Toenail
Exclusion criteria:
Patients With Diabetes Melitus, Venous Insufficiency, Platelet or Coagulation Disorders
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
A Simple Random Sampling Method Will Be Used. Treatment Candidates Will Be Placed In One of the Three Treatment Groups (i.e., Phenol 90%, TCA 100% and Radio Frequency) Using the Table of Random Numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
Since the Entire Treatment Process Will Be Carried Out By the Researcher (With the Supervision of the Thesis Committee), and the Healthcare Providers Have No Intervention, Only the Patients With Ingrown Toenail Will Be Blind. In This Regard, After Receiving the Patient's Consent, One of the Three Studied Treatment Methods Will Be Used to Treat the Patient. To Avoid Research Bias, Explanations about the Name and Details of the Treatment Method Will Not Provided to the Patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Shahid Hammat Highway, Hammat Gharb, Between the Intersection of Sheikh Fazlullah Nouri and Shahid Chamran, Iran University of Medical Sciences and Health Services
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-08-01, 1400/05/10
Ethics committee reference number
IR.IUMS.FMD.REC.1400.310
Health conditions studied
1
Description of health condition studied
Ingrown Toenail
ICD-10 code
L60.0
ICD-10 code description
Ingrowing nail
Primary outcomes
1
Description
Cure Rate of Ingrown Toenail
Timepoint
2, 14, 30, 60, 180 days after surgery
Method of measurement
Questionnaire and Photography
Secondary outcomes
empty
Intervention groups
1
Description
In This Research, Three Intervention Groups (i.e., Different Treatment Modals) Will Be Compared. All Groups Are Randomly Selected. The First Intervention Group will be Surgically Operated by Lateral Matricectomy Using Phenol 90% . The Second Intervention Group Will Be Treated With Lateral Matricectomy and TCA 100% . For the Treatment of The Third Intervention Group, The Lateral Matricectomy and Radiofrequency Will Be Used.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram hospital
Full name of responsible person
Zahra Keshavarz
Street address
Rasool Akram hospital, Maziar Mansuri Aven., Satar Khan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 937 493 5066
Email
s.zahrakeshavarz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Mousavizadeh
Street address
Rasool Akram hospital, Maziar Mansuri Ave., Satar khan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8670 4837
Email
mousavizadeh.k@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Zahra Keshavarz
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Rasool Akram hospital, Maziar Mansuri Ave., Satar khan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 937 493 5066
Email
s.zahrakeshavarz@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Keshavarz
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Rasool Akram hospital, Maziar Mansuri Ave., Satar khan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 937 493 5066
Email
s.zahrakeshavarz@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Keshavarz
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Rasool Akram hospital, Maziar Mansuri Ave., Satar khan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 937 493 5066
Email
s.zahrakeshavarz@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
Part of the data, such as the consequences of using each of the materials in surgery, the study protocol, statistical analysis, the informed consent form, the study report and the codes used for analysis are shared.
When the data will become available and for how long
The access period starts 6 months after results publication
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
If an official application is sent and permission is obtained, data usage is possible.
From where data/document is obtainable
All the Documents and Data of This Research Are Available to The Thesis Supervisor. Applicants Can Access These Documents By Referring to The Dermatology Clinic of Rasoul Akram Hospital in Tehran. In Addition, Applicants Can Submit Their Requests to zahrakeshavarz@gmail.com.
What processes are involved for a request to access data/document
The data will be sent no later than two weeks after receiving the application and verifying the identity of the applicant.