An Absorbable Suture Versus a Non-absorbable Suture in Carpal Tunnel Release, a Randomized Controlled Trial

Study Overview
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Brief Summary
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The study compares two widely used treatments in closing the wound after open carpal tunnel release surgery: absorbable and non-absorbable sutures. It is conducted as a randomized controlled trial, where the participants are divided into two research groups. The visual outcome of the scar will be evaluated a year after the surgery.

Detailed Description
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Absorbable sutures are more cost efficient and eliminate the need for suture removal both reducing costs and abolishing suture removal pain. We will study the difference in the visual outcome between the two groups. Based on former study the primary hypothesis is that there is no difference between the groups. The patients will evaluate their scars on a VAS-scale one year after the surgery. Secondarily we will focus on pain caused by the two sutures and take the suture removal pain into consideration. We expect therefore the non-absorbable suture to cause more pain in total. The evaluation will happen 2 weeks after the surgery by the patients.

Official Title
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Skin Closure With a Fast Absorbable Braided Suture Versus a Non-absorbable Monofilament Suture in Open Carpal Tunnel Release, a Randomized Controlled Trial

Conditions
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Carpal Tunnel Syndrome, Median Nerve Entrapment

Intervention / Treatment
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* Procedure: Surgical wound closed with an absorbable suture
* Procedure: Surgical wound closed with a non-absorbable suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Numbness, pain or paresthesia in the region supplied by the median nerve Admission to CTS surgery Informed consent from the patient Exclusion Criteria Previous CTS surgery Known allergy to suture materials Ongoing steroid treatment Ongoing chemotherapy Ongoing immunomodulatory treatment History of problems in wound healing as hypertrophic or keloid scars Age under 18, pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The participants are divided into two groups. The first group will get an absorbable suture and the second a non-absorbable suture.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Absorbable Suture<br>Surgical wounds of this arm will be closed with an absorbable suture. | Procedure: Surgical wound closed with an absorbable suture<br>* Patients undergoing median nerve release surgery will get their surgical wound closed with an absorbable suture according to their respective study group.<br>|
| Active Comparator: Non-absorbable suture<br>Surgical wounds of this arm will be closed with a non-absorbable suture. | Procedure: Surgical wound closed with a non-absorbable suture<br>* Patients undergoing median nerve release surgery will get their surgical wound closed with a non-absorbable suture according to their respective study group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual outcome (VAS) of the scar (nice and ugly) as evaluated by the patient | The subjective aesthetics of the scar evaluated by the patient on a 10 cm visual analog scale (VAS) ranging from very ugly to very nice. The propotion of ugly and nice scars will be reported. Outcome will be collected at one year time point. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual outcome (VAS) of the scar (nice and ugly) as evaluated by an outcomes assessor | The subjective aesthetics of the scar evaluated by an outcome assessor on a 10 cm visual analog scale (VAS) ranging from very ugly to very nice. The propotion of ugly and nice scars will be reported. Outcome will be collected at one year time point. | 1 year | 
| Pain (VAS) experienced by the patient from the sutures | The rate of any the pain in the area of the scar including pain related to possible suture removal evaluated by the patient on a 10 cm visual analog scale (VAS) ranging from no pain at all to worst pain imaginable. Propotions of patients in ten groups from 0 to 10 will be reported. Outcome will be collected at two weeks time point. | 2 weeks | 
| The Boston Carpal Tunnel Questionnaire | A disease-specific measure of self-reported symptom severity and functional status measuring the effectiveness of the treatment. Outcome will be collected preoperatively and at one year time point. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carpal tunnel, carpal tunnel syndrome, median nerve release, median nerve entrapment, surgery, suture, absorbable, non-absorbable