abSorbable vErsus Non-absorbable SuturEs for Wound Closure in Carpal Tunnel Release

Study Overview
=================
Brief Summary
-----------------
Carpal Tunnel Syndrome is a prevalent condition, up to 9% in women and 0.6% in men. Surgical decompression in the most effective treatment. After surgery, approximately 1,8% of the patients develop a wound infection. Possibly, the type of sutures used can influence the prevalence of wound infection. In this RCT the incidence of infection is investigated between the use of absorbable versus non-absorbable sutures in carpal tunnel release.

Detailed Description
-----------------
Carpal Tunnel Syndrome is a prevalent condition; up to 9% in women and 0.6% in men. It causes complaints of paresthesia, pain, numbness and loss of strength. Surgical decompression is the most effective treatment. After surgery, approximately 1,8% of the patients develop a wound infection. Possibly, the type of suture material which is used can influence the prevalence of wound infection. In current clinical practice both absorbable and non absorbable sutures are used. In literature, various hypothesis are described: Absorbable sutures could give more reaction of macrophages and therefore a higher chance on infection. This would not be the case for non-absorbable sutures, since they will be removed. However, in literature, there is still not enough evidence for superiority of absorbable or non-absorbable suture. In this RCT the incidence of infection is investigated between the use of absorbable versus non-absorbable sutures in carpal tunnel release. The primary outcome is the ASEPSIS wound score. This will be scored by independent investigators. Use of antibiotics, handtherapy and extra outpatient visits will be recorded. Patients are asked to register their NRS scores the first three weeks after surgery.

Official Title
-----------------
Absorbable Versus Non-absorbable Sutures for Wound Closure in Carpal Tunnel Release: a Randomized Controlled Trial

Conditions
-----------------
Carpal Tunnel Syndrome, Wound Infection, Suture, Complication

Intervention / Treatment
-----------------
* Procedure: Carpal Tunnel Release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • indication for carpal tunnel release Exclusion Criteria: carpal tunnel syndrome which has yet been operated injection with corticosteroids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Absorbable sutures<br>Absorbable sutures Vicryl rapide or Safil quick | Procedure: Carpal Tunnel Release<br>* Transection of flexor retinaculum for patients who have carpal tunnel syndrome<br>|
| Active Comparator: Non-absorbable sutures<br>Non-absorbable sutures Ethilon or Flexocrin | Procedure: Carpal Tunnel Release<br>* Transection of flexor retinaculum for patients who have carpal tunnel syndrome<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASEPSIS wound score (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay as inpatient prolonged over 14 days) | score based on a picture made of the wound 10-14 days post carpal tunnel release. Minimum score 0, maximum score 70, score above 40 is categorized as wound infection | 10 to 14 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS score (Numeric Rating Scale for pain) | pain score, minimum score 0, maximum score 10. Unbearable pain is scored as 10, no pain is scored as 0. | until three weeks post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carpal tunnel syndrome, wound infection, absorbable sutures, non-absorbable sutures