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

Carpal Tunnel Syndrome Clinical Trial

— SUPER  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05503719
• Other study ID #: KUH5203138
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: September 2023
• Source: Kuopio University Hospital
• Contact: Yrjänä Nietosvaara, D.Med.Sc. M.D
• Phone: (+358)44 717 6883
• Email: yrjana.nietosvaara[@]kuh.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The visual outcome of the scar will be evaluated a year after the surgery.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Median Neuropathy
• Nerve Compression Syndromes

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Finland	Kuopio University Hospital, Department of Orthopaedics, Traumatology and Hand Surgery	Kuopio	Pohjois-Savo

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	University of Eastern Finland

Country where clinical trial is conducted

Finland, 

References & Publications (16)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 year
Secondary	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.	2 weeks
Secondary	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.	1 year
Secondary	The Net Promoter Score	Client experience, the likelihood of the patient to recommend the operation to a friend or a colleague	1 year
Secondary	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.	1 year
Secondary	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.	1 year