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

Gelre Hospitals

Status: Enrolling

Conditions: Carpal Tunnel Syndrome; Suture, Complication; Wound Infection

Treatments: Procedure: Carpal Tunnel Release

Study type: Interventional

Funder types: Other

Identifiers

NCT05431101

21/551

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,604 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• indication for carpal tunnel release

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,604 participants in 2 patient groups

Absorbable sutures

Active Comparator group

Description:

Absorbable sutures Vicryl rapide or Safil quick

Treatment:

Procedure: Carpal Tunnel Release

Non-absorbable sutures

Active Comparator group

Description:

Non-absorbable sutures Ethilon or Flexocrin

Treatment:

Procedure: Carpal Tunnel Release