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Active, Not Recruiting

NCT Number: NCT05503719

An Absorbable Suture Versus a Non-absorbable Suture in 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Nerve Entrapment Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kuopio, Northern Savonia, 70210, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • University of Eastern Finland

Registry information

Official study title

Skin Closure With a Fast Absorbable Braided Suture Versus a Non-absorbable Monofilament Suture in Open Carpal Tunnel Release, a Randomized Controlled Trial

Acronym: SUPER

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 17, 2022
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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