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

NCT05503719 | Active Not Recruiting

• 1 other identifier: KUH5203138
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome; Median Nerve Entrapment

Keywords

carpal tunnel; carpal tunnel syndrome; median nerve release; median nerve entrapment; surgery; suture; absorbable; non-absorbable

Outcome Measures

Primary Outcomes (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.

  1 year

Secondary Outcomes (6)

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

  1 year

• Pain (VAS) experienced by the patient from the sutures

  2 weeks

• The Boston Carpal Tunnel Questionnaire

  1 year

• The Net Promoter Score

  1 year

• Costs

  1 year

Study Arms (2)

Absorbable Suture

EXPERIMENTAL

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

Procedure: Surgical wound closed with an absorbable suture

Non-absorbable suture

ACTIVE COMPARATOR

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

Procedure: Surgical wound closed with a non-absorbable suture

Interventions

Surgical wound closed with an absorbable suture PROCEDURE

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

Absorbable Suture

Surgical wound closed with a non-absorbable suture PROCEDURE

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

Non-absorbable suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Eastern Finland: collaborator

Study Sites (1)

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

Kuopio, Northern Savonia, 70210, Finland

Location

Related Publications (17)

• 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.

  PMID: 9660284 BACKGROUND

• 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.

  PMID: 20659358 BACKGROUND

• 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.

  PMID: 24164122 BACKGROUND

• 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.

  PMID: 27751557 BACKGROUND

• 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.

  PMID: 17374817 BACKGROUND

• 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.

  PMID: 31300226 BACKGROUND

• 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.

  PMID: 29557679 BACKGROUND

• 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.

  PMID: 8885019 BACKGROUND

• 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.

  PMID: 10411196 BACKGROUND

• 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.

  PMID: 15368623 BACKGROUND

• 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.

  PMID: 11281671 BACKGROUND

• 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.

  PMID: 15620502 BACKGROUND

• 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.

  PMID: 21987279 BACKGROUND

• 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.

  PMID: 30293628 BACKGROUND

• 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.

  PMID: 25177448 BACKGROUND

• 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.

  PMID: 18949783 BACKGROUND

• 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.

  PMID: 38626975 DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants are divided into two groups. The first group will get an absorbable suture and the second a non-absorbable suture.

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: August 17, 2022
• Study Start: September 21, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 1, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Anonymous patient level data will be available if the European Union regulations permit after the study has been finished. The end date is estimated to be 1 January 2027.
• Access Criteria: Researchers who provide a methodologically sound proposal and reviewers of the journal where article will be published will be granted access. Proposals should be directed to aukusa@student.uef.fi. To gain access, data requestors will need to sign a data access agreement.

Locations

FI (1)