SurgeryNCT02458989
Thyroid Cosmesis Study at St. Paul's Hospital, Vancouver BC
A study testing Scalpel and Electrocautery in people with Surgery, run by Dr. Sam M. Wiseman at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery
- What is being tested?
- Scalpel and Electrocautery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia, v6z1y6
Sam M Wiseman, MD, 6048069108, smwiseman@providencehealth.bc.ca
Kaye Ong, BSc, 6046822344 ext. 62883, kong@providencehealth.bc.ca
About this study
Official title: A Randomized Controlled Trial Comparing The Cosmetic Outcome Of Electrocautery Versus Scalpel For Thyroidectomy Incisions
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.
Read the detailed description
Purpose:
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
- Surgery
- Being tested
- Scalpel, Electrocautery
- Keywords
- Thyroidectomy, Thyroid surgery, Scalpel, Electrocautery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScalpelProcedure or surgery
Use of a scalpel as a first incision during thyroid operation
ElectrocauteryProcedure or surgery
Use of an electrocautery as a first incision during thyroid operation
| Study group | Role | What they receive |
|---|---|---|
| Scalpel | Active comparator | Use of a scalpel as a first incision during thyroid operation. Receives: Procedure: Scalpel |
| Electrocautery | Experimental | Use of an electrocautery as a first incision during thyroid operation. Receives: Procedure: Electrocautery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appearance of surgical scar
Measured: 6 months post operative
Appearance of surgical scar
Measured: 12 months post operative
Secondary outcomes (2)
Rate of wound infection
Measured: 6 months post operative
Rate of wound infection
Measured: 12 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Sam M. Wiseman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Sam M. Wiseman, St. Paul's Hospital, Canada
- Investigators
- Sam M Wiseman, MD, Principal investigator, University of British Columbia and St. Paul's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458989
- Sponsor's protocol ID
- Thyroid Cosmesis H14-02408
- Status last verified
- Nov 2023
- First submitted
- 19 Mar 2015
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19755082
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing The Cosmetic Outcome Of Electrocautery Versus Scalpel For Thyroidectomy Incisions
- ClinicalTrials.gov ID
- NCT02458989
- Acronym / sponsor ID
- Thyroid Cosmesis H14-02408
- Conditions
- Surgery
- Keywords
- Thyroidectomy, Thyroid surgery, Scalpel, Electrocautery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr. Sam M. WisemanUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose:
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scalpel | Active comparator | Procedure: ScalpelUse of a scalpel as a first incision during thyroid operation. |
| Electrocautery | Experimental | Procedure: ElectrocauteryUse of an electrocautery as a first incision during thyroid operation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScalpelUse of a scalpel as a first incision during thyroid operation | Procedure or surgery | Scalpel |
| ElectrocauteryUse of an electrocautery as a first incision during thyroid operation | Procedure or surgery | Electrocautery |
Primary outcome
Appearance of surgical scar
Time frame: 6 months post operative
Appearance of surgical scar
Time frame: 12 months post operative
2 secondary outcomes
Rate of wound infection
Time frame: 6 months post operative
Rate of wound infection
Time frame: 12 months post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 19755082Chau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam M Wiseman, MD principal investigator
University of British Columbia and St. Paul's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scalpel and Electrocautery in people with Surgery, run by Dr. Sam M. Wiseman at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sam M Wiseman, MD (6048069108, smwiseman@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appearance of surgical scar (time frame: 6 months post operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02458989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.