- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02791529
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
|
Skin incision performed by scalpel
|
Experimental: Electrocautery
Skin incision performed by 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
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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