Clinical trial NCT05431101: abSorbable vErsus Non-absorbable SuturEs for Wound Closure in Carpal Tunnel Release
Official title: Absorbable Versus Non-absorbable Sutures for Wound Closure in Carpal Tunnel Release: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Wound Infection
Suture, Complication
Keywords: carpal tunnel syndrome
wound infection
absorbable sutures
non-absorbable sutures
Lead sponsor: Gelre Hospitals
Sponsor class: OTHER
Collaborators: name: Deventer Ziekenhuis
First posted: 2022-06-24
Enrollment: 2604
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

• indication for carpal tunnel release

Exclusion Criteria:

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

Primary outcomes:
measure: 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)
timeFrame: 10 to 14 days post surgery
Secondary outcomes:
measure: NRS score (Numeric Rating Scale for pain)
timeFrame: until three weeks post surgery
Other outcomes:
Locations:
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuizen
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
Study officials:
References: