The comparison between scar of simple and horizontal matress sutures in open carpal tunnel release
Design
In this study, a randomized controlled clinical trial with parallel groups, double-blind, in phase 2 of the clinical trial, 42 patients with a definitive diagnosis of carpal tunnel syndrome, which was affiliated to the orthopedic clinic of Rasoul Akram Hospital from the beginning of October 2020 to the beginning of October 2021. Then patients will be randomly assigned to the two groups with a ratio of 1: 1 to two groups by random block method using random allocation software. Group 1 will include patients whose surgical incision is closed with a simple suture and group 2 will include patients whose surgical incision is closed with a horizontal suture.
Settings and conduct
In this study, 42 patients with a definitive diagnosis of carpal tunnel syndrome who will be referred to the Rasool Akram Hospital were randomly divided into two groups. Patients' surgery will be performed in an orthopedic operating room and each patient will have a type of haircut. Patients' wound follow-up will be performed in the 12th week after surgery, and a specialist examining the patient's wound will measure the thickness and height of the skin surface, and blinding for the type of suture will be performed for the specialist and patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Patients with a definitive diagnosis of carpal tunnel syndrome
2. Age 18 to 80 years
3. Conscious consent to participate in the study
Exclusion criteria:
1. Patients with a positive history of median nerve open surgery
2. Conscious dissatisfaction
Intervention groups
Intervention group: patient that their incisions will be closed with simple sutures control group: patient that their incisions will be closed with horizontal mattress sutures
Main outcome variables
Height of the scar
Width of the scar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200115046149N1
Registration date:2020-11-24, 1399/09/04
Registration timing:registered_while_recruiting
Last update:2020-11-24, 1399/09/04
Update count:0
Registration date
2020-11-24, 1399/09/04
Registrant information
Name
naseh sileymani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2264
Email address
dr.sileymani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the scar of open carpal tunnel release closure with simple and horizontal mattress sutures
Public title
Comparison of scar of simple and horizontal matress suture in open CTR
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with carpal tunnel syndrome who are first-time candidates for surgery
Exclusion criteria:
Previous open carpal tunnel release on the same side
History of other surgeries on hand
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
42
More than 1 sample in each individual
Number of samples in each individual:
21
Each hand could be a sample
Randomization (investigator's opinion)
Randomized
Randomization description
Random sequence generation software in addition to simple randomization capable of the sequential generation they are randomized by the block making method. Allocation of patients will be done randomly and by random block method using Random Allocation statistical software. Software inputs will include the total number of samples and the number of treatment groups (intervention and control). Then, after selecting the Generate random list option, the Equal Size option is selected from the Options section of the blocks section and the number of blocks is entered. The software output will be in Html or text files format and will include random numbers assigned to two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients will be divided in 2 groups in a randomized manner and the follow up examiners will not be informed about type of sutures
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
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-11-04, 1399/08/14
Ethics committee reference number
IR.IUMS.FMD.REC.1399. 466
Health conditions studied
1
Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
G56.00
ICD-10 code description
Carpal tunnel syndrome, unspecified upper limb
Primary outcomes
1
Description
Height of scar, width of scar
Timepoint
12 weeks after surgery
Method of measurement
Collis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: closing of the surgical incision with simple sutures
Category
Treatment - Surgery
2
Description
Intervention group: closing of the surgical incision with horizontal matress sutures
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool akram hospital
Full name of responsible person
Naseh sileymani
Street address
Hashemi rafsanjani ave. Sattarkhan blvd
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2264
Email
Dr.sileymani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
سید عباس متولیان
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2504
Email
research-m@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
Naseh Sileymani
Position
Orthopedist
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
hashemi rafsanjani ave. Sattarkhan blvd
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2264
Fax
Email
dr.sileymani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naseh Sileymani
Position
Orthopedist
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
hashemi rafsanjani ave. Sattarkhan blvd
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2264
Fax
Email
dr.sileymani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naseh Sileymani
Position
Orthopedist
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
hashemi rafsanjani ave. Sattarkhan blvd
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2264
Fax
Email
dr.sileymani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
To observe the ethical principle and to observe the confidentiality of patients' information.
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
Yes - There is a plan to make this available
Title and more details about the data/document
All data can potentially be shared after unidentified individuals, or only part of the data, such as information about the main outcome or the like, can be shared.
When the data will become available and for how long