Recruiting

Observational Study

Sponsor:

Dr. Sam M. Wiseman

Code:

NCT02458989

Conditions

Surgery

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Interventions

Scalpel

Electrocautery

Study Details

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.

Conditions

Surgery

Study ID

NCT02458989

Start date

Mar, 2015

Status verified date

Nov, 2023

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Scalpel

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

experimental: Electrocautery

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

Interventions

Scalpel

Use of a scalpel as a first incision during thyroid operation

Electrocautery

Use of an electrocautery as a first incision during thyroid operation

Primary outcome measure

  • Appearance of surgical scar [ Time Frame: 6 months post operative ]
  • Appearance of surgical scar [ Time Frame: 12 months post operative ]

Central Contacts and Locations

Locations

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, v6z1y6

Contacts

Principal Investigator:

Sam M Wiseman, MD

More Information

Sponsor

Dr. Sam M. Wiseman

Last update posted

Nov 28, 2023

Last verified

Nov, 2023

Keywords

  • Thyroidectomy
  • Thyroid surgery
  • Scalpel
  • Electrocautery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Sam M. Wiseman on 2023-11-28.