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| Name | Class |
|---|---|
| University of Eastern Finland | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Absorbable Suture | Experimental | Surgical wounds of this arm will be closed with an absorbable suture. |
|
| Non-absorbable suture | Active Comparator | Surgical wounds of this arm will be closed with a non-absorbable suture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio University Hospital, Department of Orthopaedics, Traumatology and Hand Surgery | Kuopio | Northern Savonia | 70210 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9660284 | Background | 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. | |
| 20659358 | 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. |
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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.
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.
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.
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The participants are divided into two groups. The first group will get an absorbable suture and the second a non-absorbable suture.
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| 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. |
|
| 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 |
| 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 |
| The Net Promoter Score | Client experience, the likelihood of the patient to recommend the operation to a friend or a colleague | 1 year |
| 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 |
| 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 |
| 24164122 | 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. |
| 27751557 | 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. |
| 17374817 | 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. |
| 31300226 | 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. |
| 29557679 | 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. |
| 8885019 | 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. |
| 10411196 | 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. |
| 15368623 | 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. |
| 11281671 | 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. |
| 15620502 | 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. |
| 21987279 | 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. |
| 30293628 | 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. |
| 25177448 | 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. |
| 18949783 | 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. |
| 38626975 | Derived | 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. |
| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D020423 | Median Neuropathy |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
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