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

• Sponsor: Turku University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02791529
• Collaborator: (none)
• Enrollment: 16
• Arms: 2
• Actual Duration (Months): 16

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome	Procedure: Electrocautery; Procedure: Scalpel	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 16 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
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pain on visual analogue scale [First postoperative day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Turku University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Turku University Hospital
• ClinicalTrials.gov Identifier: NCT02791529
• Other Study ID Numbers: TYKS/OCTR-Electro/1-2
• First Posted: Jun 6, 2016
• Last Update Posted: Mar 12, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Carpal Tunnel Syndrome

Study Results

No Results Posted as of Mar 12, 2020