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

March 11, 2020 updated by: Turku University Hospital

Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release - Randomized, Controlled Open-Label Trial

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

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 to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
Active Comparator: Scalpel
Skin incision performed by scalpel
Procedure: Scalpel
Skin incision performed by scalpel
Experimental: Electrocautery
Skin incision performed by electrocautery
Procedure: Electrocautery
Skin incision performed by electrocautery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain on visual analogue scale
Time Frame: First postoperative day
First postoperative day

Collaborators and Investigators

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

Sponsor

Turku University Hospital

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 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

June 1, 2016

First Submitted That Met QC Criteria

June 1, 2016

First Posted (Estimate)

June 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 12, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TYKS/OCTR-Electro/1-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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