NCT02458989

Brief Summary

This study looks at the difference in surgical scar outcomes between two different surgical incision methods during thyroid surgery: scalpel vs electrocautery. Patients who are already scheduled for thyroid surgery with Dr. Sam Wiseman, Endocrine Surgeon at St. Paul's Hospital, and that meet the eligibility criteria for this study will be invited to participate. After signing the informed consent form, participants will be randomized into either one of the two incision methods, but will not know which one they receive. There will be two follow-up time points: one at 6 and another at 12 months post-operative. At these time points the research team will send a letter to the participant asking them to rate the appearance of their surgical scar. They will also be asked to take a picture of their scar and send it back to the research team, so that the research team can make an assessment of their surgical scar. The study concludes when the 12 month follow-up is complete.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 1, 2015

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

10.8 years

First QC Date

March 19, 2015

Last Update Submit

November 27, 2023

Conditions

Surgery

Keywords

ThyroidectomyThyroid surgeryScalpelElectrocautery

Outcome Measures

Primary Outcomes (2)

  • Appearance of surgical scar

    6 months post operative

  • Appearance of surgical scar

    12 months post operative

Secondary Outcomes (2)

  • Rate of wound infection

    6 months post operative

  • Rate of wound infection

    12 months post operative

Other Outcomes (2)

  • Scar pain score on the POSAS Patient Scale

    6 months post operative

  • Scar pain score on the POSAS Patient Scale

    12 months post operative

Study Arms (2)

Scalpel

ACTIVE COMPARATOR

Use of a scalpel as a first incision during thyroid operation.

Procedure: Scalpel

Electrocautery

EXPERIMENTAL

Use of an electrocautery as a first incision during thyroid operation.

Procedure: Electrocautery

Interventions

ScalpelPROCEDURE

Use of a scalpel as a first incision during thyroid operation

Scalpel
ElectrocauteryPROCEDURE

Use of an electrocautery as a first incision during thyroid operation

Electrocautery

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 18 years old who have consented to conventional thyroid surgery with Dr. Sam Wiseman at St Paul's Hospital (Vancouver, BC) will be asked to participate.

You may not qualify if:

  • Patients will be excluded if they have had prior surgical incisions at the site of expected surgical incision, connective tissue disorders (e.g. Ehrlos Danlos syndrome), known keloid predilection, and lack of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, v6z1y6, Canada

RECRUITING

Related Publications (1)

  • Chau JK, Dzigielewski P, Mlynarek A, Cote DW, Allen H, Harris JR, Seikaly HR. Steel scalpel versus electrocautery blade: comparison of cosmetic and patient satisfaction outcomes of different incision methods. J Otolaryngol Head Neck Surg. 2009 Aug;38(4):427-33.

    PMID: 19755082BACKGROUND

MeSH Terms

Interventions

Laser TherapyElectrocoagulation

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, OperativeCautery

Study Officials

  • Sam M Wiseman, MD

    University of British Columbia and St. Paul's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sam M Wiseman, MD

CONTACT

6048069108smwiseman@providencehealth.bc.ca

Kaye Ong, BSc

CONTACT

6046822344kong@providencehealth.bc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2015

First Posted

June 1, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

CA(1)