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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02791529
Recruitment Status : Not yet recruiting
First Posted : June 6, 2016
Last Update Posted : August 7, 2018
Information provided by (Responsible Party):
Turku University Hospital

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).

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: Electrocautery Procedure: Scalpel Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Scalpel Versus Electrocautery for Surgical Skin Incision in Open Carpal Tunnel Release - Randomized, Controlled Open-Label Trial
Study Start Date : September 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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

Primary Outcome Measures :
  1. Pain on visual analogue scale [ Time Frame: First postoperative day ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Turku University Hospital Identifier: NCT02791529     History of Changes
Other Study ID Numbers: TYKS/OCTR-Electro/1-2
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries