NCT02791529

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).

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2016

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

1.3 years

First QC Date

June 1, 2016

Last Update Submit

March 11, 2020

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Pain on visual analogue scale

    First postoperative day

Study Arms (2)

Scalpel

ACTIVE COMPARATOR

Skin incision performed by scalpel

Procedure: Scalpel

Electrocautery

EXPERIMENTAL

Skin incision performed by electrocautery

Procedure: Electrocautery

Interventions

ElectrocauteryPROCEDURE

Skin incision performed by electrocautery

Electrocautery
ScalpelPROCEDURE

Skin incision performed by scalpel

Scalpel

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

ElectrocoagulationLaser Therapy

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

CauteryTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2016

First Posted

June 6, 2016

Study Start

September 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

March 12, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share