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

September 15, 2025 updated by: Kuopio University Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70210
        • Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Absorbable Suture
Surgical wounds of this arm will be closed with an absorbable suture.
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.
Active Comparator: Non-absorbable suture
Surgical wounds of this arm will be closed with a non-absorbable suture.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual outcome (VAS) of the scar (nice and ugly) as evaluated by the patient
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain (VAS) experienced by the patient from the sutures
Time Frame: 2 weeks
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
Time Frame: 1 year
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
Visual outcome (VAS) of the scar (nice and ugly) as evaluated by an outcomes assessor
Time Frame: 1 year
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
The Net Promoter Score
Time Frame: 1 year
Client experience, the likelihood of the patient to recommend the operation to a friend or a colleague
1 year
Costs
Time Frame: 1 year
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
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

University of Eastern Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2022

Primary Completion (Actual)

November 30, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

August 15, 2022

First Posted (Actual)

August 17, 2022

Study Record Updates

Last Update Posted (Estimated)

September 16, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5203138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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