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

Primary Purpose

Carpal Tunnel Syndrome, Median Nerve Entrapment

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Surgical wound closed with an absorbable suture
Surgical wound closed with a non-absorbable suture
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel, carpal tunnel syndrome, median nerve release, median nerve entrapment, surgery, suture, absorbable, non-absorbable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Numbness, pain or paresthesia in the region supplied by the median nerve
  • Admission to CTS surgery
  • Informed consent from the patient

Exclusion Criteria

  • Previous CTS surgery
  • Known allergy to suture materials
  • Ongoing steroid treatment
  • Ongoing chemotherapy
  • Ongoing immunomodulatory treatment
  • History of problems in wound healing as hypertrophic or keloid scars
  • Age under 18, pregnancy or breastfeeding

Sites / Locations

  • Kuopio University Hospital, Department of Orthopaedics, Traumatology and Hand SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Absorbable Suture

Non-absorbable suture

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 "very ugly" to "very nice". The propotion of ugly and nice scars will be reported. Outcome will be collected at one year time point.

Secondary Outcome Measures

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 "very ugly" to "very nice". The propotion of ugly and nice scars will be reported. Outcome will be collected at one year time point.
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.
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.

Full Information

First Posted
May 25, 2022
Last Updated
October 23, 2023
Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland
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1. Study Identification

Unique Protocol Identification Number
NCT05503719
Brief Title
An Absorbable Suture Versus a Non-absorbable Suture in Carpal Tunnel Release, a Randomized Controlled Trial
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Median Nerve Entrapment
Keywords
carpal tunnel, carpal tunnel syndrome, median nerve release, median nerve entrapment, surgery, suture, absorbable, non-absorbable

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The participants are divided into two groups. The first group will get an absorbable suture and the second a non-absorbable suture.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Absorbable Suture
Arm Type
Experimental
Arm Description
Surgical wounds of this arm will be closed with an absorbable suture.
Arm Title
Non-absorbable suture
Arm Type
Active Comparator
Arm Description
Surgical wounds of this arm will be closed with a non-absorbable suture.
Intervention Type
Procedure
Intervention Name(s)
Surgical wound closed with an absorbable suture
Intervention Description
Patients undergoing median nerve release surgery will get their surgical wound closed with an absorbable suture according to their respective study group.
Intervention Type
Procedure
Intervention Name(s)
Surgical wound closed with a non-absorbable suture
Intervention Description
Patients undergoing median nerve release surgery will get their surgical wound closed with a non-absorbable suture according to their respective study group.
Primary Outcome Measure Information:
Title
Visual outcome (VAS) of the scar (nice and ugly) as evaluated by the patient
Description
The subjective aesthetics of the scar evaluated by the patient on a 10 cm visual analog scale (VAS) ranging from "very ugly" to "very nice". The propotion of ugly and nice scars will be reported. Outcome will be collected at one year time point.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Visual outcome (VAS) of the scar (nice and ugly) as evaluated by an outcomes assessor
Description
The subjective aesthetics of the scar evaluated by an outcome assessor on a 10 cm visual analog scale (VAS) ranging from "very ugly" to "very nice". The propotion of ugly and nice scars will be reported. Outcome will be collected at one year time point.
Time Frame
1 year
Title
Pain (VAS) experienced by the patient from the sutures
Description
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.
Time Frame
2 weeks
Title
The Boston Carpal Tunnel Questionnaire
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Numbness, pain or paresthesia in the region supplied by the median nerve Admission to CTS surgery Informed consent from the patient Exclusion Criteria Previous CTS surgery Known allergy to suture materials Ongoing steroid treatment Ongoing chemotherapy Ongoing immunomodulatory treatment History of problems in wound healing as hypertrophic or keloid scars Age under 18, pregnancy or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yrjänä Nietosvaara, D.Med.Sc. M.D
Phone
(+358)44 717 6883
Email
yrjana.nietosvaara@kuh.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Mikko Räisänen, M.D.
Phone
(+358)17 173 311
Email
mikko.raisanen@kuh.fi
Facility Information:
Facility Name
Kuopio University Hospital, Department of Orthopaedics, Traumatology and Hand Surgery
City
Kuopio
State/Province
Pohjois-Savo
ZIP/Postal Code
70210
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yrjänä Nietosvaara, D.Med.Sc. M.D
Phone
(+358)44 717 6883
Email
yrjana.nietosvaara@kuh.fi
First Name & Middle Initial & Last Name & Degree
Mikko Räisänen, MD
Phone
(+358)17 173 311
Email
mikko.raisanen@kuh.fi
First Name & Middle Initial & Last Name & Degree
Joonas Sirola, MD, PhD, Adjunct professor
First Name & Middle Initial & Last Name & Degree
Aukusti Savolainen, BM
First Name & Middle Initial & Last Name & Degree
Mikael Hytönen, BM
First Name & Middle Initial & Last Name & Degree
Noora Heikkinen, BM
First Name & Middle Initial & Last Name & Degree
Aleksi Reito, MD, PhD, Adjunct professor
First Name & Middle Initial & Last Name & Degree
Mikko P Räisänen, MD
First Name & Middle Initial & Last Name & Degree
Yrjänä Nietosvaara, MD, PhD, professor

12. IPD Sharing Statement

Plan to Share IPD
No
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An Absorbable Suture Versus a Non-absorbable Suture in Carpal Tunnel Release, a Randomized Controlled Trial

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