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Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release (OCTR-Electro)

Primary Purpose

Carpal Tunnel Syndrome

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Electrocautery
Scalpel
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 - 60 years
  • Scheduled to undergo open carpal tunnel release (OCTR) by a study group member
  • Gives informed consent
  • diagnosis of chronic carpal tunnel syndrome

Exclusion Criteria:

  • -Any current underlying systemic illness or condition that may affect wound healing (e.g. diabetes or chronic vascular disease)
  • History of severe systemic or focal illness (e.g. previous myocardial infarction, chronic obstructive pulmonary disease)
  • Chronic skin condition in the affected upper limb (e.g. psoriasis)
  • Pregnancy
  • Inability to comprehend the consent form (in Finnish) or inability to give consent
  • Previous surgery or scar in the palmar aspect of the affected wrist
  • Recurrent carpal tunnel syndrome
  • Previous significant trauma of the affected upper extremity (including distal radius fracture) or suspicion of acute onset carpal tunnel syndrome

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Scalpel

    Electrocautery

    Arm Description

    Skin incision performed by scalpel

    Skin incision performed by electrocautery

    Outcomes

    Primary Outcome Measures

    Pain on visual analogue scale

    Secondary Outcome Measures

    Full Information

    First Posted
    June 1, 2016
    Last Updated
    March 11, 2020
    Sponsor
    Turku University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02791529
    Brief Title
    Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release
    Acronym
    OCTR-Electro
    Official Title
    Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release - Randomized, Controlled Open-Label Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Terminated
    Why Stopped
    Intervention was inferior in pilot trial.
    Study Start Date
    September 2016 (Actual)
    Primary Completion Date
    January 2018 (Actual)
    Study Completion Date
    January 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Turku University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The use of electrocautery for surgical skin incision in general surgery is known to decrease post-operative pain. This study compares the use of scalpel and electrocautery for surgical skin incision in open carpal tunnel release (OCTR).
    Detailed Description
    The use of electrocautery for surgical skin incision in general surgery is known to decrease post-operative pain. This study compares the use of scalpel and electrocautery for surgical skin incision in open carpal tunnel release (OCTR).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carpal Tunnel Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Scalpel
    Arm Type
    Active Comparator
    Arm Description
    Skin incision performed by scalpel
    Arm Title
    Electrocautery
    Arm Type
    Experimental
    Arm Description
    Skin incision performed by electrocautery
    Intervention Type
    Procedure
    Intervention Name(s)
    Electrocautery
    Intervention Description
    Skin incision performed by electrocautery
    Intervention Type
    Procedure
    Intervention Name(s)
    Scalpel
    Intervention Description
    Skin incision performed by scalpel
    Primary Outcome Measure Information:
    Title
    Pain on visual analogue scale
    Time Frame
    First postoperative day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 - 60 years Scheduled to undergo open carpal tunnel release (OCTR) by a study group member Gives informed consent diagnosis of chronic carpal tunnel syndrome Exclusion Criteria: -Any current underlying systemic illness or condition that may affect wound healing (e.g. diabetes or chronic vascular disease) History of severe systemic or focal illness (e.g. previous myocardial infarction, chronic obstructive pulmonary disease) Chronic skin condition in the affected upper limb (e.g. psoriasis) Pregnancy Inability to comprehend the consent form (in Finnish) or inability to give consent Previous surgery or scar in the palmar aspect of the affected wrist Recurrent carpal tunnel syndrome Previous significant trauma of the affected upper extremity (including distal radius fracture) or suspicion of acute onset carpal tunnel syndrome

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release

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