Comparison of the effect of surgical site closure with Monocrly Vs. Nylon sutures on the incidence, severity, and duration of pillar pain and surgical site scar in patients with carpal tunnel syndrome
The aim of this study is to compare the effect of using Monocryl Vs. Nylon sutures for surgical site closure on the incidence, severity, and duration of pillar pain, as well as scar quality in patients undergoing carpal tunnel release surgery.
Design
Randomized, controlled clinical trial with two parallel arms (Monocryl group and Nylon group), double-blinded; the total sample size is 70 patients (35 per arm). randomization will be performed using the EAND function in Excel software.
Settings and conduct
Study setting: Plastic surgery department of 15th khordad hospital, Tehran; Study population: patients with carpal tunnel syndrome undergoing standard surgery; Blinding: this is a double-blinded study; The patient as well as the individual responsible for postoperative visits, data recording, and statistical analysis are fully blinded to the allocated groups; The surgeon remains unaware of the suture type until the final skin closure to ensure identical technique.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients candidate for carpal tunnel release surgery; providing informed consent;
Exclusion criteria : Age under 18; diabetes mellitus; systemic diseases affecting wound healing; history of trauma or fracture in the affected hand; recurrent cases of the disease.
Intervention groups
Intervention group: surgical site closure using 4-0 Monocryl suture in a subcuticular fashion; Control group: surgical site closure using 4-0 Nylon suture in a subcuticular fashion; other surgical steps are identical in both groups.
Main outcome variables
Incidence of pillar pain; severity of pillar pain; duration of pillar pain; surgical site scar quality; all will be measured after the surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260309068977N2
Registration date:2026-05-12, 1405/02/22
Registration timing:registered_while_recruiting
Last update:2026-05-12, 1405/02/22
Update count:0
Registration date
2026-05-12, 1405/02/22
Registrant information
Name
soraya shahrokh shahraki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8890 1108
Email address
golbahar.shahraki@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-03-01, 1404/12/10
Expected recruitment end date
2026-12-21, 1405/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of surgical site closure with Monocrly Vs. Nylon sutures on the incidence, severity, and duration of pillar pain and surgical site scar in patients with carpal tunnel syndrome
Public title
Comparison of monocryl and nylon suture in CTR surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a confirmed diagnosis of carpal tunnel syndrome
patients who are candidates for standard carpal tunnel release surgery
Patients who have provided written informed consent to participate in the study
Exclusion criteria:
Age under 18 years or individuals unable to make decision and provide informed consent
Individuals with diabetes mellitus
Individuals with systemic diseases affecting wound healing, such as collagen vascular diseases
Individuals with a history of fracture or extensive soft tissue injury in the hand affected by carpal tunnel syndrome
Individuals consuming chemotherapy drugs or corticosteroids
individuals with recurrent carpal tunnel syndrome
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be performed in this study. The random sequence will be generated using the RAND function in Microsoft Excel software by an individual not involved in the surgical team. to ensure allocation concealment, sequentially numbered, opaque, sealed envelopes will be used; the intervention type for each patient will be revealed only in the operating room after the envelope is opened by a surgical assistant.
Blinding (investigator's opinion)
Double blinded
Blinding description
At the end of the operation, exactly before closing the surgical site, the surgeon is informed of the type of suture to be used for the patient. In this way, the surgical technique will be identical in all patients. All postoperative visits, data recording, and data analysis are performed by someone who is unaware of the study's objectives and the groupings.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
15th Khordad hospital, Shaid Azodi Street
City
Tehran
Province
Tehran
Postal code
1598763513
Approval date
2026-02-24, 1404/12/05
Ethics committee reference number
IR.SBMU.MSP.REC.1404.795
Health conditions studied
1
Description of health condition studied
Carpal tunnel syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
Prevalence, severity and duration of Pillar pain
Timepoint
1,6,12,24 weeks post operation
Method of measurement
Visual analogue scale (VAS)
Secondary outcomes
1
Description
Surgical site Scar quality
Timepoint
1, 6, 12 and 24 weeks post operation
Method of measurement
Vancouver scar scale (VSS)
Intervention groups
1
Description
Intervention group: Open (standard) carpal tunnel release surgical site closure using 4-0 Monocryl suture (manufactured by Ethicon, USA) in a subcuticular manner.
Category
Treatment - Surgery
2
Description
Control group: Open (standard) carpal tunnel release surgical site closure using 4-0 Nylon suture (manufactured by Supa, Iran) in a subcuticular manner.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Plastic surgery 15th Khordad Hospital in Tehran
Full name of responsible person
Muhammad Hossein Baqeri Pour
Street address
Shshid Azodi street
City
Tehran
Province
Tehran
Postal code
1598763513
Phone
+98 21 8894 3434
Email
15khordad@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Headquarters of Shihid Beheshti university of Medical Sciences, Shahid Arabi Street, Yemen Street, Shaid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
vcresearch@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohamad Hossein Baqeri pour
Position
Plastic surgery resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
15th khordad Hospital, Shahid Azodi Street
City
Tehran
Province
Tehran
Postal code
1598763513
Phone
+98 21 8894 3434
Email
graypackage@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohamad Hossein Baqeri pour
Position
Plastic surgery resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
15th khordad Hospital, Shahid Azodi Street
City
Tehran
Province
Tehran
Postal code
1598763513
Phone
+98 21 8894 3434
Email
graypackage@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohamad Hossein Baqeri pour
Position
Plastic surgery resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
15th khordad Hospital, Shahid Azodi Street
City
Tehran
Province
Tehran
Postal code
1598763513
Phone
+98 21 8894 3434
Email
graypackage@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available