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

Last updated: September 13, 2023
Sponsor: Gelre Hospitals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carpal Tunnel Syndrome

Treatment

Carpal Tunnel Release

Clinical Study ID

NCT05431101
21/551
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

• indication for carpal tunnel release

Exclusion

Exclusion Criteria:

  • carpal tunnel syndrome which has yet been operated
  • injection with corticosteroids

Study Design

Total Participants: 2604
Treatment Group(s): 1
Primary Treatment: Carpal Tunnel Release
Phase:
Study Start date:
May 01, 2022
Estimated Completion Date:
April 01, 2027

Study 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.

Connect with a study center

  • Gelre Ziekenhuizen

    Apeldoorn, 7334DZ
    Netherlands

    Active - Recruiting

  • Deventer Ziekenhuis

    Deventer, 7416SE
    Netherlands

    Active - Recruiting

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