abSorbable vErsus Non-absorbable SuturEs for Wound Closure in Carpal Tunnel Release
SENSE
Absorbable Versus Non-absorbable Sutures for Wound Closure in Carpal Tunnel Release: a Randomized Controlled Trial
1 other identifier
interventional
2,604
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 21, 2022
CompletedFirst Posted
Study publicly available on registry
June 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
August 26, 2025
August 1, 2025
5.8 years
June 21, 2022
August 19, 2025
Conditions
Keywords
Outcome Measures
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)
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 Outcomes (1)
NRS score (Numeric Rating Scale for pain)
until three weeks post surgery
Study Arms (2)
Absorbable sutures
ACTIVE COMPARATORAbsorbable sutures Vicryl rapide or Safil quick
Non-absorbable sutures
ACTIVE COMPARATORNon-absorbable sutures Ethilon or Flexocrin
Interventions
Transection of flexor retinaculum for patients who have carpal tunnel syndrome
Eligibility Criteria
You may qualify if:
- indication for carpal tunnel release
You may not qualify if:
- carpal tunnel syndrome which has yet been operated
- injection with corticosteroids
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gelre Hospitalslead
- Deventer Ziekenhuiscollaborator
Study Sites (2)
Gelre Ziekenhuizen
Apeldoorn, 7334DZ, Netherlands
Deventer Ziekenhuis
Deventer, 7416SE, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
June 21, 2022
First Posted
June 24, 2022
Study Start
May 1, 2022
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
August 26, 2025
Record last verified: 2025-08