Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05431101

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Infections Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Suture, Complication Wound Infection Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gelre Ziekenhuizen, Apeldoorn, Netherlands

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • indication for carpal tunnel release

Exclusion criteria

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

Treatment and study plan

Carpal tunnel release

Procedure

Transection of flexor retinaculum for patients who have carpal tunnel syndrome

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. NRS score (Numeric Rating Scale for pain)

    Time frame: until three weeks post surgery

    pain score, minimum score 0, maximum score 10. Unbearable pain is scored as 10, no pain is scored as 0.

Study contacts

Contact information is provided by the study sponsor or research team.

Pauline Verhaegen, MD PHD

CONTACT

[email protected]

0555811244

Sponsors and collaborators

Lead sponsor

Gelre Hospitals

Other

Collaborators

  • Deventer Ziekenhuis

Registry information

Official study title

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

Acronym: SENSE

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jun 24, 2022
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.