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

NCT ID: NCT05431101

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2604 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2028-04-01

Brief Summary

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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

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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.

Conditions

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Carpal Tunnel Syndrome Wound Infection Suture, Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Absorbable sutures

Absorbable sutures Vicryl rapide or Safil quick

Group Type ACTIVE_COMPARATOR

Carpal Tunnel Release

Intervention Type PROCEDURE

Transection of flexor retinaculum for patients who have carpal tunnel syndrome

Non-absorbable sutures

Non-absorbable sutures Ethilon or Flexocrin

Group Type ACTIVE_COMPARATOR

Carpal Tunnel Release

Intervention Type PROCEDURE

Transection of flexor retinaculum for patients who have carpal tunnel syndrome

Interventions

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Carpal Tunnel Release

Transection of flexor retinaculum for patients who have carpal tunnel syndrome

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

• indication for carpal tunnel release

Exclusion Criteria

* carpal tunnel syndrome which has yet been operated
* injection with corticosteroids
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Deventer Ziekenhuis

OTHER

Sponsor Role collaborator

Gelre Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Pauline Verhaegen

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gelre Ziekenhuizen

Apeldoorn, , Netherlands

Site Status RECRUITING

Deventer Ziekenhuis

Deventer, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Pauline Verhaegen, MD PHD

Role: CONTACT

0555811244

Facility Contacts

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Pauline Verhaegen

Role: primary

0555811244

Edwin Wijburg

Role: primary

0555811244

Other Identifiers

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21/551

Identifier Type: -

Identifier Source: org_study_id

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