Scalpel vs Electrocautery for Thyroid Surgery

Recruiting in Palo Alto (17 mi)

Overseen by Sam M Wiseman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dr. Sam M. Wiseman

Disqualifiers: Prior incisions, Connective disorders, Keloid, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinator or your doctor.

What data supports the effectiveness of the treatment Electrocautery for thyroid surgery?

Research suggests that using electrocautery (a tool that uses heat to cut tissue) for surgical incisions can reduce blood loss and the time it takes to make the incision compared to a scalpel, although it may be linked to higher rates of wound infection and healing issues. ^{1 2 3 4 5}

Is it safe to use electrocautery or a scalpel for thyroid surgery?

Research shows that using electrocautery (a tool that uses heat to cut tissue) for thyroid surgery is generally safe, but there may be concerns about wound healing and scarring. Studies comparing it to a scalpel (a traditional surgical knife) suggest that both methods are safe, though electrocautery might lead to less blood loss and pain. ^{1 2 4 6 7}

How does the treatment using electrocautery and scalpel for thyroid surgery differ from other treatments?

Electrocautery uses electrical current to cut tissue and control bleeding, which can lead to risks like poor wound healing and scarring, while a scalpel is a traditional surgical knife. Compared to newer technologies like the ultrasonic scalpel, electrocautery is more cost-effective but may pose risks for patients with pacemakers. ^{1 7 8 9 10}

Research Team

Sam M Wiseman, MD

Principal Investigator

University of British Columbia and St. Paul's Hospital

Eligibility Criteria

This trial is for adults over 18 who are scheduled for conventional thyroid surgery with Dr. Sam Wiseman at St. Paul's Hospital in Vancouver, BC. Participants must consent to the study and be willing to follow up on their surgical scar appearance.

Inclusion Criteria

I am over 18 and agreed to thyroid surgery with Dr. Wiseman.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo thyroid surgery using either scalpel or electrocautery incision methods

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for cosmetic outcomes, wound infection, and postoperative pain at 6 and 12 months post-surgery

12 months

2 visits (virtual)

Treatment Details

Interventions

• Electrocautery (N/A)
• Scalpel (N/A)

Trial Overview The study compares two methods of making surgical incisions during thyroid surgery: using a scalpel or electrocautery. Patients will be randomly assigned to one method without knowing which one, and their scar appearance will be evaluated at 6 and 12 months post-surgery.

Participant Groups

Group I: Electrocautery Experimental Treatment 1 Intervention

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

Group II: Scalpel Active Control 1 Intervention

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

Electrocautery is already approved in Canada for the following indications:

Approved in Canada as Electrocautery for:

• General surgical procedures
• Including but not limited to thyroid surgery

Who Is Running the Clinical Trial?

Dr. Sam M. Wiseman

Lead Sponsor

Trials

1

Recruited

60+

Findings from Research

In a study of 100 patients undergoing thyroidectomy, electrocautery resulted in greater tissue damage and postoperative discomfort compared to scalpel use, particularly noted 7 days after surgery.

Despite the increased early complications associated with electrocautery, both methods yielded similar clinical and cosmetic outcomes 6 months post-surgery, indicating that electrocautery can be used effectively without compromising long-term results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound complications and clinical results of electrocautery versus a scalpel to create a cutaneous flap in thyroidectomy: a prospective randomized trial. Uludag, M., Yetkin, G., Ozel, A., et al.[2022]

Using a diathermy blade for surgical incisions can lead to quicker procedures and reduced blood loss compared to traditional knives.

Patients experience less postoperative pain with diathermy blades, and there are no negative impacts on wound healing or cosmetic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical incision by high frequency cautery. Vedbhushan, ST., Mulla, MA., Haroonrasid, ., et al.[2021]

A controlled clinical study indicates that skin incisions made with scalpels and electrosurgical instruments have minimal differences in outcomes.

This suggests that both methods are equally effective for surgical procedures, providing flexibility in choosing the appropriate tool based on the surgeon's preference or specific clinical situation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrosurgical skin incision. Mann, W., Klippel, CH.[2019]

A systematic review of 6 randomized controlled trials involving 1234 participants found that electrocautery for skin incisions does not increase the risk of wound infections or negatively affect scar appearance compared to traditional scalpels.

Electrocautery significantly reduces incision time and postoperative wound pain, suggesting it is a safe and effective alternative for surgical skin incisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of electrocautery versus scalpel for surgical skin incisions. Aird, LN., Brown, CJ.[2022]

Cutting electrocautery significantly reduces blood loss, incisional time, and postoperative pain compared to scalpel incisions, based on a meta-analysis of 41 studies involving 6422 participants.

There were no significant differences in wound infection rates or cosmetic outcomes between electrocautery and scalpel techniques, suggesting that electrocautery is a safe and effective option for surgical incisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutting electrocautery versus scalpel for surgical incisions: a systematic review and meta-analysis. Ismail, A., Abushouk, AI., Elmaraezy, A., et al.[2023]

In a study of 197 patients, electrocautery for skin incisions resulted in significantly shorter incision times and less blood loss compared to traditional scalpel incisions, indicating its efficiency in surgical procedures.

Patients who underwent electrocautery reported lower postoperative pain levels, while there was no significant difference in wound infection rates or healing times between the two methods, suggesting electrocautery is a safe alternative to scalpel incisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diathermy versus Scalpel Incision in a Heterogeneous Cohort of General Surgery Patients in a Nigerian Teaching Hospital. Ayandipo, OO., Afuwape, OO., Irabor, D., et al.[2020]

In a study of 239 patients undergoing thyroidectomy, the use of electrocautery for cutaneous flap creation was found to be as safe as using scissors, with no significant difference in post-operative wound complication rates (7.9% for electrocautery vs 10.6% for scissors).

Factors such as age, body mass index (BMI), cutaneous tissue depth, and tissue weight were identified as significant risk factors for wound complications, with a BMI over 27.5 kg/m2 increasing the risk by 13.7 times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrocautery for cutaneous flap creation during thyroidectomy: a randomised, controlled study. Barbaros, U., Erbil, Y., Aksakal, N., et al.[2022]

The use of an ultrasonic scalpel (Harmonic scalpel) during open-heart reoperation is presented as a safe alternative to electrocautery for patients with implanted pacemakers, reducing the risk of pacemaker dysfunction.

This case demonstrates the efficacy of the ultrasonic scalpel in a high-risk surgical setting, suggesting it may be a preferable option for similar patients in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an ultrasonic scalpel in the open-heart reoperation of a patient with pacemaker. Ozeren, M., Doğan, OV., Düzgün, C., et al.[2019]

In a multicenter randomized controlled trial involving 261 patients, the use of an ultrasonic scalpel during total thyroidectomy resulted in a 17% reduction in operative time compared to conventional techniques.

The ultrasonic scalpel demonstrated similar safety profiles to traditional methods, with no significant differences in postoperative complications, while also leading to lower postoperative drainage volumes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total thyroidectomy with ultrasonic scalpel: a multicenter, randomized controlled trial. Kowalski, LP., Sanabria, A., Vartanian, JG., et al.[2022]

In a study of 60 patients undergoing total thyroidectomy, the bipolar radiofrequency ablation device significantly reduced the mean operative time by 15.35 minutes compared to the ultrasonic scalpel, making it a more time-efficient option.

Both devices showed no significant differences in complication rates or other outcomes, indicating that the bipolar radiofrequency device is a safe and effective alternative to the more expensive ultrasonic scalpel for thyroid surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Bipolar Radiofrequency Ablation Device in Hemostasis during Thyroidectomy in Comparison with Ultrasonic Scalpel: A Comparative Study. Kadem, SG., Alabbood, MH.[2022]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Wound complications and clinical results of electrocautery versus a scalpel to create a cutaneous flap in thyroidectomy: a prospective randomized trial. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Surgical incision by high frequency cautery. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Electrosurgical skin incision. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of electrocautery versus scalpel for surgical skin incisions. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cutting electrocautery versus scalpel for surgical incisions: a systematic review and meta-analysis. [2023]

6. India pubmed.ncbi.nlm.nih.gov

Diathermy versus Scalpel Incision in a Heterogeneous Cohort of General Surgery Patients in a Nigerian Teaching Hospital. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Electrocautery for cutaneous flap creation during thyroidectomy: a randomised, controlled study. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Use of an ultrasonic scalpel in the open-heart reoperation of a patient with pacemaker. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Total thyroidectomy with ultrasonic scalpel: a multicenter, randomized controlled trial. [2022]

10. India pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Bipolar Radiofrequency Ablation Device in Hemostasis during Thyroidectomy in Comparison with Ultrasonic Scalpel: A Comparative Study. [2022]