Comparison of the effect of repairing patients with tip injury between two methods of restoring with Flap and restoration with Secondary intention
Design
This study is a one-blinded clinical trial. The study population will be included all patients with fingertip lesions referred to Taleghani hospital of Kermanshah. Sixty 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 one-blinded one, in which the participants will not know which intervention group they will be in. After the surgery, restoration, the length of hospitalization and beauty are evaluated by the assistant of the project and the two groups are compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with fingertip lesions; Patient consent
Exclusion: Patients who are unable to perform finger repair surgery for any reason
Intervention groups
In the first intervention group, patients with fingertip lesions will undergo flap surgery. In the second intervention group, patients with fingertip lesions will undergo secondary intention surgery.
Main outcome variables
The length of hospitalization and beauty
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N132
Registration date:2019-12-17, 1398/09/26
Registration timing:registered_while_recruiting
Last update:2019-12-17, 1398/09/26
Update count:0
Registration date
2019-12-17, 1398/09/26
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
2019-12-16, 1398/09/25
Expected recruitment end date
2020-06-18, 1399/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of repairing patients with tip injury between two methods of restoring with Flap and restoration with Secondary intention
Public title
Comparison of the effect of repairing patients with tip injury between two methods of restoring with Flap and restoration with Secondary intention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with fingertip lesions
Patient consent
Exclusion criteria:
Patients who are unable to perform finger repair surgery for any reason
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly by coin toss
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the researcher is blinded to the intervention, which is a surgical procedure and does not know which in intervention groups they are and which surgical treatment will be used to treat them.
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
2019-10-15, 1398/07/23
Ethics committee reference number
ir.kums.rec.1398.825
Health conditions studied
1
Description of health condition studied
fingertip lesions
ICD-10 code
B08.8
ICD-10 code description
Other specified viral infections characterized by skin and mucous membrane lesions
Primary outcomes
1
Description
During the period of hospitalization
Timepoint
Before and after the end of the study
Method of measurement
According to documents
2
Description
Beauty
Timepoint
Before and after the end of the study
Method of measurement
observation of doctor
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, patients with fingertip lesions will undergo flap surgery.
Category
Treatment - Surgery
2
Description
In the second intervention group, patients with fingertip lesions will undergo secondary intention surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Pedram Akhbari
Street address
Shahid Beheshti Boulevard, Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7984
Email
pedramkhbary@yahoo.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 0011
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
Pedram Akhbari
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
pedramkhbary@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Amirian
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Plastic Surgery
Street address
Shahid Beheshti Boulevard, Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7984
Email
pedramkhbary@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Pedram Akhbari
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
009838367984
Email
pedramkhbary@yahoo.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
Undecided - It is not yet known if there will be 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
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
3 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