abSorbable vErsus Non-absorbable SuturEs for Wound Closure in Carpal Tunnel Release
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carpal Tunnel Release.
- Who it may be relevant to
- Registry conditions: Carpal Tunnel Syndrome, Wound Infection, Suture, Complication. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Absorbable Versus Non-absorbable Sutures for Wound Closure in Carpal Tunnel Release: a Randomized Controlled Trial
Overview
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.
Interventions
- Procedure Carpal Tunnel Release
Transection of flexor retinaculum for patients who have carpal tunnel syndrome
Primary outcome measures
- 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) [Time frame: 10 to 14 days post surgery]
Secondary outcome measures (1)
- NRS score (Numeric Rating Scale for pain) [Time frame: until three weeks post surgery]
Eligibility criteria
Inclusion criteria
- indication for carpal tunnel release
Exclusion criteria
- carpal tunnel syndrome which has yet been operated
- injection with corticosteroids
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 2 centers
- Gelre Ziekenhuizen — Apeldoorn
- Deventer Ziekenhuis — Deventer
Identifiers
NCT: NCT05431101 · 21/551