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Trials / Recruiting

RecruitingNCT05431101

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
2,604 (estimated)
Sponsor
Gelre Hospitals · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECarpal Tunnel ReleaseTransection of flexor retinaculum for patients who have carpal tunnel syndrome

Timeline

Start date
2022-05-01
Primary completion
2028-03-01
Completion
2028-04-01
First posted
2022-06-24
Last updated
2025-08-26

Locations

2 sites across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT05431101. Inclusion in this directory is not an endorsement.

abSorbable vErsus Non-absorbable SuturEs for Wound Closure in Carpal Tunnel Release (NCT05431101) · Clinical Trials Directory