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

Carpal Tunnel Syndrome Clinical Trial

— SENSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431101
• Other study ID #: 21/551
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: April 1, 2027

Study information

• Verified date: September 2023
• Source: Gelre Hospitals
• Contact: Pauline Verhaegen, MD PHD
• Phone: 0555811244
• Email: paulineverhaegen[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2604
• Est. completion date: April 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• indication for carpal tunnel release

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Suture, Complication
• Wound Infection
• Wounds and Injuries

Intervention

Procedure:
• Carpal Tunnel Release
Transection of flexor retinaculum for patients who have carpal tunnel syndrome

Locations

Country	Name	City	State
Netherlands	Gelre Ziekenhuizen	Apeldoorn
Netherlands	Deventer Ziekenhuis	Deventer

Sponsors (2)

Lead Sponsor	Collaborator
Gelre Hospitals	Deventer Ziekenhuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	10 to 14 days post surgery
Secondary	NRS score (Numeric Rating Scale for pain)	pain score, minimum score 0, maximum score 10. Unbearable pain is scored as 10, no pain is scored as 0.	until three weeks post surgery