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

Not Applicable

Recruiting

• Conditions: Wound Infection; Carpal Tunnel Syndrome; Suture, Complication
• Interventions: Procedure: Carpal Tunnel Release

• Registration Number: NCT05431101
• Lead Sponsor: Gelre Hospitals

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.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-24
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-14
• Primary Completion: 2027-03-01
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2604

Inclusion Criteria

• indication for carpal tunnel release

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Absorbable sutures	Carpal Tunnel Release	Absorbable sutures Vicryl rapide or Safil quick
Non-absorbable sutures	Carpal Tunnel Release	Non-absorbable sutures Ethilon or Flexocrin

Primary Outcome Measures

Name	Time	Method
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)	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 Outcome Measures

Name	Time	Method
NRS score (Numeric Rating Scale for pain)	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.

Trial Locations

Locations (2)

Gelre Ziekenhuizen; 🇳🇱 Apeldoorn, Netherlands

Deventer Ziekenhuis; 🇳🇱 Deventer, Netherlands