Comparison of the effect of vicryl thread with nylon thread with a diameter of 0.6 on the scar of the nasal columella after rhinoplasty surgery.
Design
This study was designed as a prospective, randomized, double-blind, parallel-group clinical trial. A total of 56 patients were enrolled and randomly allocated to two equal groups of 28 participants each. The control group underwent columellar incision closure using a permanent non-absorbable suture (6-0 Nylon), while the intervention group received closure with a non-rapid absorbable suture (6-0 Vicryl).
Settings and conduct
The clinical trial study aims to compare the effect of Vicryl sutures with nylon sutures on columellar scarring after rhinoplasty in patients visiting Amir Alam Hospital in Tehran in the year 1403 (2024-2025).
Participants/Inclusion and exclusion criteria
All patients over the age of 18 who undergo primary open rhinoplasty for any reason other than nasal reconstruction related to cancer removal and are able to provide informed consent will be included in the study. Patients with a history of previous nasal surgery who do not have an incision on the columella will also be included. Patients with previous surgery that involves a columellar incision and patients with a known history of skin disorders affecting scarring will be excluded from the study. Additionally, patients with missing data or loss to follow-up will also be excluded from the study.
Criteria for exclusion include being under 18 years old, a history of skin disease, and previous nasal surgery history.
Intervention groups
The control group will have the columellar incision closed with a permanent non-absorbable suture (6-0 nylon) and the intervention group will have the incision closed with an absorbable suture (6-0 non-rapid vicryl).
Main outcome variables
Age؛ Gender؛ Group؛ Time؛ SBES score؛ PSAQ score and subscales
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250129064567N1
Registration date:2026-04-11, 1405/01/22
Registration timing:retrospective
Last update:2026-04-11, 1405/01/22
Update count:0
Registration date
2026-04-11, 1405/01/22
Registrant information
Name
Sadegh Aliheydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8828 4036
Email address
sadegh.aliheydari1991@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-19, 1404/01/30
Expected recruitment end date
2026-04-18, 1405/01/29
Actual recruitment start date
2025-03-21, 1404/01/01
Actual recruitment end date
2026-03-21, 1405/01/01
Trial completion date
2026-04-04, 1405/01/15
Scientific title
Comparison of columella scar between nylon thread and vicryl thread in rhinoplasty
Public title
Comparison of sutures in the front of the nose between nylon thread and vicryl thread in nose surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patients over the age of 18 who have undergone primary open rhinoplasty for any reason other than nasal reconstruction related to cancer removal and are able to give informed consent.
Patients with a history of previous nose surgery who do not have an incision on the columella will also be included
Exclusion criteria:
Patients with previous surgery involving a columellar incision and patients with a known history of skin disorders affecting scarring.
Patients with missing information or patient loss in follow-up
Patients under 18 years old
Age
From 18 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
56
Actual sample size reached:
56
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization was employed. In this approach, each eligible patient had an equal probability of being assigned to either the intervention group (Vicryl) or the control group (Nylon). The allocation for each patient was performed independently and without considering the number of participants already assigned to each group. This process ensures that the group assignment is completely unpredictable and free from selection bias.
Both the surgical team and the researchers were blinded to the group allocation prior to the operation (allocation concealment). The type of suture material used for each patient became known only after the procedure. One characteristic of simple randomization is that, although the probability of assignment is equal for both groups, the final number of patients in each group may not be exactly the same. This slight imbalance is more common in studies with smaller sample sizes and is considered a normal feature of this method.
The use of simple randomization reduces selection bias, increases the internal validity of the study, and provides a fair basis for comparing outcomes between the two groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences, Amira Alam Hospital
Street address
Amir Alam Hospital, Saadi Northern Street, Darvaze Dolat, Ferdowsi Square
City
tehran
Province
Tehran
Postal code
1145765111
Approval date
2024-08-20, 1403/05/30
Ethics committee reference number
IR.TUMS.AMIRALAM.REC.1403.025
Health conditions studied
1
Description of health condition studied
Comparison of columella scars between nylon and vicryl sutures in rhinoplasty
Stony Brook Assessment Scale (SBES) and Patient Assessment Questionnaire (PSAQ)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The control group included closure of the columellar incision with a permanent nonabsorbable suture (6-0 nylon).
Category
Treatment - Surgery
2
Description
Intervention group: The intervention group will be closed with an absorbable suture (6-0 Vicryl non-rapid).
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralam Hospital
Full name of responsible person
Behrooz Shaternia
Street address
Amir Alam Hospital., Saadi Northern Street., Darvaze Dolat., Ferdowsi Square
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6672 7060
Fax
+98 21 6670 8103
Email
hamiralam@sina.tums.ac.ir
Web page address
https://amiralam.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Behrooz Shaternea
Street address
Amir Alam Hospital., Saadi Northern Street., Darvaze Dolat., Ferdowsi Square
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6670 8103
Fax
+98 21 6670 8103
Email
Hamiralam@sina.tums.ac.ir
Web page address
https://amiralam.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sadegh Aliheydari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Amir Alam Hospital., Saadi Northern Street., Darvaze Dolat., Ferdowsi Square
City
Tehran
Province
Tehran
Postal code
4561638461
Phone
+98 21 8828 4036
Fax
Email
sadegh.aliheydari1991@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sadegh Aliheydari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Amir Alam Hospital., Saadi Northern Street., Darvaze Dolat., Ferdowsi Square
City
Tehran
Province
Tehran
Postal code
4561638461
Phone
+98 21 8828 4036
Fax
Email
sadegh.aliheydari1991@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sadegh Aliheydari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Amir Alam Hospital., Saadi Northern Street., Darvaze Dolat., Ferdowsi Square
City
Tehran
Province
Tehran
Postal code
4561638461
Phone
+98 21 8828 4036
Fax
Email
sadegh.aliheydari1991@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
Yes - There is a plan to make this available
Title and more details about the data/document
Information obtained from data summarization is given.
When the data will become available and for how long
After finishing the article and concluding
To whom data/document is available
Everyone
Under which criteria data/document could be used
In order to complete the article correctly
From where data/document is obtainable
Tehran University of Medical Sciences, Amir A'lam Hospital
0216672706064 with Ms. Alipour, Head of Hospital Education
09037900972 Dr. Sadegh Aliheydari via SMS
Email sadegh.aliheydari1991@gmail.com
Dr. Sadegh Aliheydari's postal code: 4561638461
What processes are involved for a request to access data/document