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

Carpal Tunnel Syndrome Clinical Trial

— OCTR-Electro  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02791529
• Other study ID #: TYKS/OCTR-Electro/1-2
• Status: Terminated
• Phase: Phase 1
• Start date: September 2016
• Est. completion date: January 2018

Study information

• Verified date: March 2020
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Procedure:
• Electrocautery
Skin incision performed by electrocautery
• Scalpel
Skin incision performed by scalpel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on visual analogue scale		First postoperative day