Clinical trial NCT05503719: An Absorbable Suture Versus a Non-absorbable Suture in Carpal Tunnel Release, a Randomized Controlled Trial
Official title: Skin Closure With a Fast Absorbable Braided Suture Versus a Non-absorbable Monofilament Suture in Open Carpal Tunnel Release, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Median Nerve Entrapment
Keywords: carpal tunnel
carpal tunnel syndrome
median nerve release
median nerve entrapment
surgery
suture
absorbable
non-absorbable
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2022-08-17
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants are divided into two groups. The first group will get an absorbable suture and the second a non-absorbable suture.
Primary purpose: TREATMENT

Brief summary: The study compares two widely used treatments in closing the wound after open carpal tunnel release surgery: absorbable and non-absorbable sutures. It is conducted as a randomized controlled trial, where the participants are divided into two research groups. The visual outcome of the scar will be evaluated a year after the surgery.

Detailed description: Absorbable sutures are more cost efficient and eliminate the need for suture removal both reducing costs and abolishing suture removal pain. We will study the difference in the visual outcome between the two groups. Based on former study the primary hypothesis is that there is no difference between the groups. The patients will evaluate their scars on a VAS-scale one year after the surgery. Secondarily we will focus on pain caused by the two sutures and take the suture removal pain into consideration. We expect therefore the non-absorbable suture to cause more pain in total. The evaluation will happen 2 weeks after the surgery by the patients.

Eligibility criteria: Inclusion Criteria

* carpal tunnel syndrome diagnosed with electro near my-graphs
* symptoms typical of carpal tunnel syndrome
* referral to carpal tunnel release
* informed consent signed
* the ability to receive the virtual questionnaire via email and answer it
* the ability to understand and answer the Finnish questionnaires

Exclusion Criteria

* repeat surgery
* known allergy to suture materials
* ongoing systemic steroid treatment
* ongoing chemotherapy
* ongoing immunomodulatory treatment
* past hypertrophic or keloid scars or other severe disturbances in wound healing
* age under 18, pregnancy or breastfeeding

Primary outcomes:
measure: Visual outcome (VAS) of the scar (nice and ugly) as evaluated by the patient
timeFrame: 1 year
Secondary outcomes:
measure: Visual outcome (VAS) of the scar (nice and ugly) as evaluated by an outcomes assessor
timeFrame: 1 year
measure: Pain (VAS) experienced by the patient from the sutures
timeFrame: 2 weeks
measure: The Boston Carpal Tunnel Questionnaire
timeFrame: 1 year
measure: The Net Promoter Score
timeFrame: 1 year
measure: Costs
timeFrame: 1 year
measure: Adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital, Department of Orthopaedics, Traumatology and Hand Surgery
state: Pohjois-Savo
Study officials:
References:
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