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

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ClinicalTrials.gov Identifier: NCT02791529
Recruitment Status : Not yet recruiting
First Posted : June 6, 2016
Last Update Posted : June 6, 2016
Sponsor:
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
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

Responsible Party: Turku University Hospital
ClinicalTrials.gov 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: June 6, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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