Scalpel Versus Electrocautery for Surgical Skin Incision... | NCT02791529

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

NCT02791529

Sponsor

Turku University Hospital

Status

Terminated

Last Update Posted

Mar 12, 2020Actual

Enrollment

16Actual

Phase

Phase 1

Conditions

Carpal Tunnel Syndrome

Interventions

Electrocautery
Scalpel

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Intervention was inferior in pilot trial.

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Jan 2018Actual

Completion Date

Jan 2018Actual

First Submitted Date

Jun 1, 2016

First Submission Date that Met QC Criteria

Jun 1, 2016

First Posted Date

Jun 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2020

Last Update Posted Date

Mar 12, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Scalpel	Active Comparator	Skin incision performed by scalpel	Procedure: Scalpel
Electrocautery	Experimental	Skin incision performed by electrocautery	Procedure: Electrocautery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Electrocautery	Procedure	Skin incision performed by electrocautery	Electrocautery

Measure	Description	Time Frame
Pain on visual analogue scale		First postoperative day

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002349	Carpal Tunnel Syndrome

Ancestor Terms

ID	Term
D020423	Median Neuropathy
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004564	Electrocoagulation
D053685	Laser Therapy

Ancestor Terms

ID	Term
D002425	Cautery
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided