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Carpal Tunnel SyndromeSUPERNCT05503719

An Absorbable Suture Versus a Non-absorbable Suture in Carpal Tunnel Release, a Randomized Controlled Trial

A study testing Surgical wound closed with an absorbable suture and Surgical wound closed with a non-absorbable suture in people with Carpal Tunnel Syndrome and Median Nerve Entrapment, run by Kuopio University Hospital at 1 site in Finland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Surgical wound closed with an absorbable suture and Surgical wound closed with a non-absorbable suture
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteFinland
Study dates
21 Sep 2022to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Kuopio University Hospital, Department of Orthopaedics, Traumatology and Hand Surgery

    Kuopio, Northern Savonia, 70210

Other trials in Finland

About this study

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

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.

Read the 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.

Being tested
Surgical wound closed with an absorbable suture, Surgical wound closed with a non-absorbable suture
Keywords
carpal tunnel, carpal tunnel syndrome, median nerve release, median nerve entrapment, surgery, suture, absorbable, non-absorbable
Medical subject headings
Carpal Tunnel Syndrome, Median Neuropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgical wound closed with an absorbable sutureProcedure or surgery

    Patients undergoing median nerve release surgery will get their surgical wound closed with an absorbable suture according to their respective study group.

  • Surgical wound closed with a non-absorbable sutureProcedure or surgery

    Patients undergoing median nerve release surgery will get their surgical wound closed with a non-absorbable suture according to their respective study group.

Study groups in NCT05503719
Study groupRoleWhat they receive
Absorbable SutureExperimentalSurgical wounds of this arm will be closed with an absorbable suture.
Receives: Procedure: Surgical wound closed with an absorbable suture
Non-absorbable sutureActive comparatorSurgical wounds of this arm will be closed with a non-absorbable suture.
Receives: Procedure: Surgical wound closed with a non-absorbable suture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual outcome (VAS) of the scar (nice and ugly) as evaluated by the patient

    The subjective aesthetics of the scar evaluated by the patient on a 10 cm visual analog scale (VAS) ranging from "the ugliest scar possible" to "the most beautiful scar possible". The proportion of ugly and nice scars will be reported. Outcome will be collected at one year time point.

    Measured: 1 year

Secondary outcomes (6)

  1. Visual outcome (VAS) of the scar (nice and ugly) as evaluated by an outcomes assessor

    The subjective aesthetics of the scar evaluated by an outcome assessor on a 10 cm visual analog scale (VAS) ranging from "the ugliest scar possible" to "the most beautiful scar possible". The proportion of ugly and nice scars will be reported. Outcome will be collected at one year time point.

    Measured: 1 year

  2. Pain (VAS) experienced by the patient from the sutures

    The rate of any the pain in the area of the scar including pain related to possible suture removal evaluated by the patient on a 10 cm visual analog scale (VAS) ranging from "no pain at all" to "worst pain imaginable". Propotions of patients in ten groups from 0 to 10 will be reported. Outcome will be collected at two weeks time point.

    Measured: 2 weeks

  3. The Boston Carpal Tunnel Questionnaire

    A disease-specific measure of self-reported symptom severity and functional status measuring the effectiveness of the treatment. Outcome will be collected preoperatively and at one year time point.

    Measured: 1 year

  4. The Net Promoter Score

    Client experience, the likelihood of the patient to recommend the operation to a friend or a colleague

    Measured: 1 year

  5. Costs

    The mean difference between the two study arms in treatment costs.The required data will be analysed from the trial data and Finnish healthcare registries.

    Measured: 1 year

  6. Adverse events

    Adverse events will be monitored throughout the trial, and patients will be instructed to promptly report any potential serious adverse events. At the one-year follow-up point, the questionnaires will include an inquiry about whether the patient has experienced any adverse events.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2022
  2. Study start21 Sep 2022
  3. Primary completion30 Nov 2024
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The participants are divided into two groups. The first group will get an absorbable suture and the second a non-absorbable suture.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05503719
Sponsor's protocol ID
KUH5203138
Acronym
SUPER
Status last verified
Sep 2025
First submitted
25 May 2022
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Pseudonymised patient-level data along with the study protocol, the informed consent form and the analytic code will be made available in case of a methologically sound proposal.

Publications

  • Quinn JV, Wells GA. An assessment of clinical wound evaluation scales. Acad Emerg Med. 1998 Jun;5(6):583-6. doi: 10.1111/j.1553-2712.1998.tb02465.x.

    PubMed 9660284

  • Kundra RK, Newman S, Saithna A, Lewis AC, Srinivasan S, Srinivasan K. Absorbable or non-absorbable sutures? A prospective, randomised evaluation of aesthetic outcomes in patients undergoing elective day-case hand and wrist surgery. Ann R Coll Surg Engl. 2010 Nov;92(8):665-7. doi: 10.1308/003588410X12699663905113. Epub 2010 Jul 19.

    PubMed 20659358

  • Dosani A, Khan SK, Gray S, Joseph S, Whittaker IA. Clinical outcome and cost comparison of carpal tunnel wound closure with monocryl and ethilon: a prospective study. Hand Surg. 2013;18(2):189-92. doi: 10.1142/S0218810413500226.

    PubMed 24164122

  • Padua L, Coraci D, Erra C, Pazzaglia C, Paolasso I, Loreti C, Caliandro P, Hobson-Webb LD. Carpal tunnel syndrome: clinical features, diagnosis, and management. Lancet Neurol. 2016 Nov;15(12):1273-1284. doi: 10.1016/S1474-4422(16)30231-9. Epub 2016 Oct 11.

    PubMed 27751557

  • Van Spall HG, Toren A, Kiss A, Fowler RA. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review. JAMA. 2007 Mar 21;297(11):1233-40. doi: 10.1001/jama.297.11.1233.

    PubMed 17374817

  • Zhang D, Earp BE, Blazar P. Evaluation and Management of Unsuccessful Carpal Tunnel Release. J Hand Surg Am. 2019 Sep;44(9):779-786. doi: 10.1016/j.jhsa.2019.05.018. Epub 2019 Jul 9.

    PubMed 31300226

  • Zhang D, Blazar P, Earp BE. Rates of Complications and Secondary Surgeries of Mini-Open Carpal Tunnel Release. Hand (N Y). 2019 Jul;14(4):471-476. doi: 10.1177/1558944718765226. Epub 2018 Mar 20.

    PubMed 29557679

  • Povlsen B, Tegnell I. Incidence and natural history of touch allodynia after open carpal tunnel release. Scand J Plast Reconstr Surg Hand Surg. 1996 Sep;30(3):221-5. doi: 10.3109/02844319609062819.

    PubMed 8885019

  • Atroshi I, Gummesson C, Johnsson R, Ornstein E, Ranstam J, Rosen I. Prevalence of carpal tunnel syndrome in a general population. JAMA. 1999 Jul 14;282(2):153-8. doi: 10.1001/jama.282.2.153.

    PubMed 10411196

  • Menovsky T, Bartels RH, van Lindert EL, Grotenhuis JA. Skin closure in carpal tunnel surgery: a prospective comparative study between nylon, polyglactin 910 and stainless steel sutures. Hand Surg. 2004 Jul;9(1):35-8. doi: 10.1142/s0218810404002017.

    PubMed 15368623

  • Erel E, Pleasance PI, Ahmed O, Hart NB. Absorbable versus non-absorbable suture in carpal tunnel decompression. J Hand Surg Br. 2001 Apr;26(2):157-8. doi: 10.1054/jhsb.2000.0545.

    PubMed 11281671

  • Kharwadkar N, Naique S, Molitor PJ. Prospective randomized trial comparing absorbable and non-absorbable sutures in open carpal tunnel release. J Hand Surg Br. 2005 Feb;30(1):92-5. doi: 10.1016/j.jhsb.2004.10.009.

    PubMed 15620502

  • Theopold C, Potter S, Dempsey M, O'Shaughnessy M. A randomised controlled trial of absorbable versus non-absorbable sutures for skin closure after open carpal tunnel release. J Hand Surg Eur Vol. 2012 May;37(4):350-3. doi: 10.1177/1753193411422334. Epub 2011 Oct 10.

    PubMed 21987279

  • Wang L. Guiding Treatment for Carpal Tunnel Syndrome. Phys Med Rehabil Clin N Am. 2018 Nov;29(4):751-760. doi: 10.1016/j.pmr.2018.06.009. Epub 2018 Sep 17.

    PubMed 30293628

  • Kim PT, Lee HJ, Kim TG, Jeon IH. Current approaches for carpal tunnel syndrome. Clin Orthop Surg. 2014 Sep;6(3):253-7. doi: 10.4055/cios.2014.6.3.253. Epub 2014 Aug 5.

    PubMed 25177448

Questions about this trial

What is this clinical trial studying?

A study testing Surgical wound closed with an absorbable suture and Surgical wound closed with a non-absorbable suture in people with Carpal Tunnel Syndrome and Median Nerve Entrapment, run by Kuopio University Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual outcome (VAS) of the scar (nice and ugly) as evaluated by the patient (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05503719, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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