Thyroid Cosmesis Study at St. Paul's Hospital, Vancouver BC
NCT ID: NCT02458989
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2015-03-31
2025-12-31
Brief Summary
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Detailed Description
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To evaluates the difference in thyroid cosmesis between two different surgical incision methods during thyroidectomy: scalpel vs electrocautery.
Hypotheses:
The investigators' hypotheses is that there is no difference in the cosmetic outcome of surgical incision during thyroidectomy by either a scalpel or electrocautery.
Justification:
Very few studies have addressed whether electrocautery produces a cosmetically inferior surgical scar in an objective manner. While some studies have commented briefly on the cosmesis of electrocautery scars, only one previous randomized clinical trials to date have evaluated the cosmesis of electrocautery and scalpel incisions using a validated scar assessment tool. In this study, Chau et al. found that after 6 months postoperatively there was no difference in objective cosmetic outcome or subjective patient satisfaction between the two techniques. This study was a relatively smaller trial, evaluating a total of 38 incisions, thus a larger scale study would be warranted.
A further advantage of electrocautery over scalpels is the decreased risk of surgical injuries. Approximately 17% of all surgical sharps injuries are due to scalpel blades, while only 2% were associated with electrocautery devices. As awareness and concern over blood born diseases increases, further efforts to reduce sharp injuries including replacing scalpels with electrocautery when possible should be investigated.
Objectives:
Aim 1: To compare the cosmetic outcome of surgical scars resulting from scalpel and electrocautery incisions.
Aim 2: To determine rates of wound infection associated with each technique.
Aim 3: To assess if electrocautery incisions are associated with a difference in postoperative pain compared to incisions made by a scalpel.
Research Method:
Patients who are already scheduled for thyroid surgery with Dr. Sam Wiseman at St. Paul's Hospital in Vancouver, BC, 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 be blinded as to which one they receive. There will be two follow-up time points: one at 6 months and another at 12 months postoperative. At these time points the research team will send a letter to the participant asking them to rate the appearance of their surgical scar, rate of their wound infection and the degree of their post operative pain using the Patient Observer Scar Assessment Scale (POSAS). They will also be asked to take a picture of their scar and send it back to the research team so the research team can make a similar assessment.
Statistical Analysis:
Once the research team receives the participant's questionnaire and photo, the images of their surgical scars will be evaluated by independent, trained, and blinded observers who will use the Patient Observer Scar Assessment Scale (POSAS) and the Vancouver Scar Scale (VSS) to evaluate the cosmesis of the surgical scar. The participants questionnaires will also be evaluated by the surgical team to assess Objective: Aim #3. The study concludes when the 12 month follow-up and these assessment by the research team is complete.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Scalpel
Use of a scalpel as a first incision during thyroid operation.
Scalpel
Use of a scalpel as a first incision during thyroid operation
Electrocautery
Use of an electrocautery as a first incision during thyroid operation.
Electrocautery
Use of an electrocautery as a first incision during thyroid operation
Interventions
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Scalpel
Use of a scalpel as a first incision during thyroid operation
Electrocautery
Use of an electrocautery as a first incision during thyroid operation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
19 Years
ALL
Yes
Sponsors
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Dr. Sam M. Wiseman
OTHER
Responsible Party
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Dr. Sam M. Wiseman
Principal Investigator
Principal Investigators
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Sam M Wiseman, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia and St. Paul's Hospital
Locations
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St. Paul's Hospital
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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Thyroid Cosmesis H14-02408
Identifier Type: -
Identifier Source: org_study_id