Comparison of skin repair using different types of sutures in carpal tunnel syndrome surgery
Design
Clinical trial with parallel groups, double-blind, randomized, phase 2 on 93 patients
Settings and conduct
This information was requested by randomized clinical trial method. In this study, patients are divided into three groups. The first group has surgical incision repair with 4-0 monocryl suture, the second group has repair with 4-0 nylon suture, and the third group has repair with 4-0 prolene suture. In all three groups, the repair is performed with continuous and subcuticular suture. All patients are dressed in a similar way and refer for follow-up at 2 and 6 weeks after surgery. Wound assessment is performed in all three groups at the first post-op visit. Sutures are removed in the nylon and prolene group at the first post-op visit. All patients are evaluated by the POSAS questionnaire at the first and second post-op visits. The above variables are recorded separately in both groups at the second and sixth weeks after surgery, and the findings are analyzed in the software environment.
Participants/Inclusion and exclusion criteria
The inclusion criteria for the study included all patients with carpal tunnel syndrome who underwent surgery
Intervention groups
In this study, one of 3 types of threads, monocryl, nylon or prolene is used randomly for skin repair
Main outcome variables
The main outcome of this study is to find the best thread to reduce pain and scarring at the surgical site of patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250315065078N1
Registration date:2025-06-04, 1404/03/14
Registration timing:registered_while_recruiting
Last update:2025-06-04, 1404/03/14
Update count:0
Registration date
2025-06-04, 1404/03/14
Registrant information
Name
Milad Najafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 279 6698
Email address
najafimilad4731@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-21, 1404/01/01
Expected recruitment end date
2026-03-21, 1405/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized controlled trial comparing three methods of skin repair with nylon, prolene and monocryl threads after carpal tunnel release surgery
Public title
Comparison of skin repair with different types of sutures in carpal tunnel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with carpal tunnel syndrome who undergo surgery
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
93
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the Restricted Randomization method of Block Randomization. Blocking is usually used to balance the number of samples allocated to each of the study groups. The size of all blocks is equal and in this trial we will have three groups of 9 blocks of nine (including 3 participants from each group) and 2 groups of six (including 3 participants from each group). Then, in order to randomly select the generated blocks, random number generation software such as the R language will be used and 12 numbers will be randomly generated from 1 to 12 to select the blocks.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, only the treating physician is aware of the type of suture used, and the patient is unaware of the type of suture used. Postoperative evaluation of patients is performed by a trained evaluator who has no role in the treatment of the patients, is unaware of the division of patients into different groups, and is unaware of the type of suture used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Scarring rate in skin repair after carpal tunnel syndrome surgery
Timepoint
View of the surgical scar 2 and 6 weeks later
Method of measurement
Observation and examination of the surgical site
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with carpal tunnel syndrome who undergo surgery will be divided into 3 groups, and each group will be repaired randomly with monocryl, nylon, or prolene sutures