Comparison of two methods of using suture and diode laser tissue soldering on closing incisions created after alar resection surgery
Design
A clinical trial with a control group with a parallel-group design, double-blind; randomized; Phase 2-3, on 23 patients. Block randomization method will be used for randomization.
Settings and conduct
This controlled clinical trial study is conducted in 2023 at the Basth Hospital in Hamedan. Incisions created after nasal resection surgery are compared to two laser and suture procedure.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18 years and more; The first experience with nose surgery; Requires surgical resection of the nasal bridge.
Exclusion criteria: Trauma patients, Congenital defects
Intervention groups
Intervention group: On one side of the nose, the incision site is sutured with a diode laser (808 nm, 0.5 W in 5 seconds), and on the other side, the incision site is sutured with Supa 6 zero nylon thread.
Main outcome variables
The quality of the cut closure, Infection, and Dehiscence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N28
Registration date:2023-06-17, 1402/03/27
Registration timing:prospective
Last update:2023-06-17, 1402/03/27
Update count:0
Registration date
2023-06-17, 1402/03/27
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of using suture and diode laser tissue soldering on closing incisions created after alar resection surgery.
Public title
Using suture and diode laser tissue soldering on closing incisions created after alar resection surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Eighteen years and older.
The first experience of nose surgery
Requires surgical resection of nasal bridge
Exclusion criteria:
Trauma patients
Congenital defects
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
23
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will randomly assign the cases to intervention and control groups. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are removed. The four paper sheets will be then placed back into the container, and this action will be repeated until the sample size is reached.
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
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-05-20, 1402/02/30
Ethics committee reference number
IR.UMSHA.REC.1402.183
Health conditions studied
1
Description of health condition studied
alar resection surgery
ICD-10 code
Z41.1
ICD-10 code description
Encounter for cosmetic surgery
Primary outcomes
1
Description
The quality of the cut closure
Timepoint
A week, a month and 6 months later
Method of measurement
Examination of the incision site with Stony Brook Scar Evaluation Scale
2
Description
Infection
Timepoint
Examination of the incision site
Method of measurement
Examination of the incision site
3
Description
Dehiscence
Timepoint
Examination of the incision site
Method of measurement
Examination of the incision site
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:On one side of the nose, the cutting site is treated with a diodes laser (808 nm, 0.5W in 5 seconds).
Category
Treatment - Devices
2
Description
Control group: On one side of the nose, the incision is sutured with Supa 6 zero nylon thread.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Mohammad Reza Jamalpour
Street address
Hamedan-Fatemi Blvd.
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3265 0030
Email
jamalpour1972@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohei
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh street
City
Hamdan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Rezvani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Hamedan-Fatemi Blvd
City
Hamdan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0064
Email
erfanrezvanisy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Jamlpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hamedan-Fatemi Blvd.
City
Hamadn
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1059
Email
jamalpour1972@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Rezvani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Hamedan-Fatemi Blvd.
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0064
Email
erfanrezvanisy@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