investigation of the results of deep flexor tendon healing of Zone II hand using 4-strand and 6-strand with prolene sutures
Design
This study is a non-blinded clinical trial. The study population will be included all patients with a ruptured deep flexor tendon of Zone II hand referred to Taleghani Hospital of Kermanshah. 50 eligible patients will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
This study that will be conducted in Taleghani hospital of Kermanshah is a non-blinded one. Eligible patients will receive 4 and 6 strand suture tendon repair.Three months after the end of the study, the rate of remission will be compared in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with ruptured deep flexor tendons of the fingers
Exclusion criteria: Patients with bone damage and crushing; Patients with a severe finger injury
Intervention groups
The first intervention group will receive a 4-strand suture tendon repair
The second intervention group will receive a 6-strand suture tendon repair
Main outcome variables
Rate of remission
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N139
Registration date:2020-02-14, 1398/11/25
Registration timing:registered_while_recruiting
Last update:2020-02-14, 1398/11/25
Update count:0
Registration date
2020-02-14, 1398/11/25
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-14, 1398/11/25
Expected recruitment end date
2020-08-15, 1399/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the results of deep flexor tendon healing of Zone II hand using 4-strand and 6-strand with prolene sutures
Public title
Evaluation of the results of deep flexor tendon healing of Zone II hand using 4-strand and 6-strand with prolene sutures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ruptured deep flexor tendons of the fingers
Exclusion criteria:
Patients with bone damage and crushing
Patients with severe finger injury
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random number table, patients are divided into two groups of 25. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the control group.
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 Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-12-17, 1398/09/26
Ethics committee reference number
IR.KUMS.REC.1398.942
Health conditions studied
1
Description of health condition studied
Tendon repair
ICD-10 code
M66.3
ICD-10 code description
Spontaneous rupture of flexor tendons
Primary outcomes
1
Description
Rate of remission
Timepoint
3 months after the end of the study
Method of measurement
By the angle gauge
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive a 4-strand suture tendon repair
Category
Treatment - Surgery
2
Description
The second intervention group will receive a 6-strand suture tendon repair
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Yosef Poorhesam
Street address
Shahid Beheshti Boulevard, Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7984
Email
Y.poorhsam2020@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
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
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
Kermanshah University of Medical Sciences
Full name of responsible person
Yosef Poorhesam
Position
Resident of General Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Boulevard, Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7984
Email
Y.poorhsam2020@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mohammadbagher Heydari
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Plastic Surgery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Mohammadbagher_heydari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Yosef Poorhesam
Position
Resident of General Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahid Beheshti Boulevard, Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7984
Email
Y.poorhsam2020@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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail