abSorbable vErsus Non-absorbable SuturEs for Wound Closure in Carpal Tunnel Release
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGelre Hospitals
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
carpal tunnel syndrome which has yet been operated
injection with corticosteroids
Trial design
Design model
Parallel
Treatments tested in this trial
Carpal Tunnel Release
Procedure/SurgeryTransection of flexor retinaculum for patients who have carpal tunnel syndrome
Treatment groups
2,604 Participants
are divided into 2 treatment groupsGroup A: Absorbable suturesActive comparator 1 intervention
Group B: Non-absorbable suturesActive comparator 1 intervention
Trial outcomes
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
Time frame
10 to 14 days post surgerySecondary outcomes
1
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.
Time frame
until three weeks post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Gelre Hospitals
Lead sponsor
Deventer Ziekenhuis
Collaborator
Source ClinicalTrials.gov