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IRCT20250501065557N1 IRCT 2025-05-20 Tehran University of Medical Sciences Pillar Pain After Carpal Tunnel Release Comparison of Skin Closure Techniques in Carpal Tunnel Release: A Randomized Controlled Trial Assessing Postoperative Pillar Pain and Scar Quality 2025-05-22 anticipated 128 Complete https://irct.ir/trial/83262 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study possesses several unique design features. First, a double-blinded assessment protocol was employed: patients were unaware of their group allocation, and the postoperative outcome assessor was blinded to group assignment and remained completely independent of the surgical team. Second, the study utilized a culturally adapted and psychometrically validated Persian version of the Patient and Observer Scar Assessment Scale (POSAS), ensuring reliable and standardized scar evaluation for the target population. Third, all surgical procedures were performed by a single fellowship-trained hand surgeon, which minimized variability in surgical technique. Fourth, the study compared two distinct yet commonly used skin closure methods—subcuticular absorbable Monocryl sutures and interrupted non-absorbable Nylon sutures—allowing for a meaningful evaluation of the impact of suture type on postoperative outcomes, Randomization description: In this study, block randomization with variable block sizes (4, 6, and 8) will be performed using a computer-generated random sequence. This method is designed to ensure balanced allocation of participants across the two groups while minimizing the predictability of the assignment sequence. The unit of randomization is the individual, and each participant will be independently assigned to one of the two study groups. To cover the total sample size of 128 participants, a total of 23 blocks will be used, consisting of 11 blocks of size 4, 6 blocks of size 6, and 6 blocks of size 8. Within each block, participants will be allocated equally and randomly to the two groups. The randomization sequence will be generated using R statistical software by an independent research coordinator who is not involved in patient recruitment or outcome assessment. To ensure allocation concealment, sequentially numbered, sealed, opaque envelopes will be used. Each envelope will be opened by the investigator only after the patient meets the eligibility criteria and is formally enrolled in the study. This procedure is intended to prevent allocation bias and to preserve the internal validity of the trial, Blinding description: All postoperative assessments were performed by a single trained evaluator who was independent of the surgical team and had no involvement in any part of the surgical procedure. The evaluator was unaware of group allocation at the time of patient enrollment, and the patients were also blinded to their assigned group. Thus, the study was conducted in a double-blinded manner to minimize assessment and performance bias. N/A Pillar pain after carpal tunnel release. Intervention 1: In the intervention group, skin closure will be performed using continuous subcuticular suturing with 4-0 absorbable Monocryl following open carpal tunnel release. This technique involves placing the suture beneath the skin surface, eliminating the need for removal during follow-up. All procedures in this group will be carried out under standardized conditions by a fellowship-trained hand surgeon, following the same postoperative care protocol as the control group. Intervention 2: Control group: In the control group, skin closure will be performed using non-absorbable 4-0 Nylon sutures applied with an interrupted vertical mattress technique following open carpal tunnel release. These sutures will be removed at the first postoperative visit. All surgeries in this group will also be performed under standardized conditions by a fellowship-trained hand surgeon, following the same postoperative care protocol as the intervention group. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to ethical considerations, concerns about participant confidentiality, and the lack of an established secure data-sharing infrastructure, there is currently no plan to share individual participant data.
public Naghizadeh
Forsat Shirazi
Tehran Iran (Islamic Republic of) 1419933813 +98 21 6612 0457 hamednaghizadeh@yahoo.com Tehran University of Medical Sciences scientific Hamed Naghizadeh
Forsat Shirazi
Tehran Iran (Islamic Republic of) 1419933813 +98 21 6612 0457 hamednaghizadeh@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years old scheduled for carpal tunnel surgery 18 years no limit Both Patients under 18 years of age Pregnant individuals Unable to provide reliable postoperative feedback due to cognitive or communication limitations Patients scheduled for concurrent procedures such as trigger finger or cubital tunnel release Individuals who declined to participate Those whose surgeries were canceled or not scheduled Patients excluded due to enrollment or protocol deviations Treatment - Surgery Treatment - Surgery In the intervention group, skin closure will be performed using continuous subcuticular suturing with 4-0 absorbable Monocryl following open carpal tunnel release. This technique involves placing the suture beneath the skin surface, eliminating the need for removal during follow-up. All procedures in this group will be carried out under standardized conditions by a fellowship-trained hand surgeon, following the same postoperative care protocol as the control group. Control group: In the control group, skin closure will be performed using non-absorbable 4-0 Nylon sutures applied with an interrupted vertical mattress technique following open carpal tunnel release. These sutures will be removed at the first postoperative visit. All surgeries in this group will also be performed under standardized conditions by a fellowship-trained hand surgeon, following the same postoperative care protocol as the intervention group. Pillar pain, defined as pain in the thenar and hypothenar regions following open carpal tunnel release, will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Scar quality will be evaluated using the Patient and Observer Scar Assessment Scale (POSAS), which includes two components. The Patient Scale consists of six items—pain, itching, color, stiffness, thickness, and irregularity—each scored from 1 (similar to normal skin) to 10 (worst condition). The Observer Scale also includes six items—vascularity, pigmentation, thickness, relief, pliability, and surface area—scored on the same scale. Higher total scores in both scales indicate poorer scar quality. Timepoint: 2 weeks postoperatively - 6 weeks postoperatively - 3 months (12 weeks) postoperatively. Method of measurement: Pillar pain, defined as pain in the thenar and hypothenar regions following open carpal tunnel release, will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Scar quality will be evaluated using the Patient and Observer Scar Assessment Scale (POSAS), which includes two components. The Patient Scale consists of six items—pain, itching, color, stiffness, thickness, and irregularity—each scored from 1 (similar to normal skin) to 10 (worst condition). The Observer Scale also includes six items—vascularity, pigmentation, thickness, relief, pliability, and surface area—scored on the same scale. Higher total scores in both scales indicate poorer scar quality. Tehran University of Medical Sciences Approved 2024-12-04 Ethics committee of TEHRAN University of Medical Sciences Forsat Shirazi Tehran Tehran Iran (Islamic Republic of)