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

NCT ID: NCT05503719

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-21

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Carpal Tunnel Syndrome Median Nerve Entrapment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The participants are divided into two groups. The first group will get an absorbable suture and the second a non-absorbable suture.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Absorbable Suture

Surgical wounds of this arm will be closed with an absorbable suture.

Group Type EXPERIMENTAL

Surgical wound closed with an absorbable suture

Intervention Type PROCEDURE

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

Non-absorbable suture

Surgical wounds of this arm will be closed with a non-absorbable suture.

Group Type ACTIVE_COMPARATOR

Surgical wound closed with a non-absorbable suture

Intervention Type PROCEDURE

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

Interventions

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Surgical wound closed with an absorbable suture

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

Intervention Type PROCEDURE

Surgical wound closed with a non-absorbable suture

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Eastern Finland

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Kuopio, Northern Savonia, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type BACKGROUND
PMID: 9660284 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20659358 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24164122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27751557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17374817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31300226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29557679 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8885019 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10411196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15368623 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11281671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15620502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21987279 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30293628 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25177448 (View on PubMed)

Boya H, Ozcan O, Ozteki N HH. Long-term complications of open carpal tunnel release. Muscle Nerve. 2008 Nov;38(5):1443-1446. doi: 10.1002/mus.21068.

Reference Type BACKGROUND
PMID: 18949783 (View on PubMed)

Savolainen A, Nietosvaara Y, Sirola J, Hytonen M, Reito A, Heikkinen N, Raisanen MP. Skin closUre in carPal tunnEl Release (SUPER): protocol for a blinded randomised controlled trial comparing absorbable and non-absorbable sutures in carpal tunnel release. BMJ Open. 2024 Apr 16;14(4):e082289. doi: 10.1136/bmjopen-2023-082289.

Reference Type DERIVED
PMID: 38626975 (View on PubMed)

Other Identifiers

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KUH5203138

Identifier Type: -

Identifier Source: org_study_id

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