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

NCT ID: NCT02791529

Last Updated: 2020-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carpal Tunnel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Scalpel

Skin incision performed by scalpel

Group Type ACTIVE_COMPARATOR

Scalpel

Intervention Type PROCEDURE

Skin incision performed by scalpel

Electrocautery

Skin incision performed by electrocautery

Group Type EXPERIMENTAL

Electrocautery

Intervention Type PROCEDURE

Skin incision performed by electrocautery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Electrocautery

Skin incision performed by electrocautery

Intervention Type PROCEDURE

Scalpel

Skin incision performed by scalpel

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TYKS/OCTR-Electro/1-2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.