RecruitingNAINTERVENTIONAL

Cosmetic Outcome of Electrocautery, Scalpel and PEAK PlasmaBlade for Surgical Breast Incisions

This study is looking at how the type of surgical tool used during breast cancer surgery might affect the appearance of a scar. Researchers are comparing three different methods for making the initial cut: a traditional scalpel, standard electrocautery (which uses heat to cut and seal blood vessels), and a newer device called the PEAK PlasmaBlade. The main goal is to see if any of these tools lead to a better-looking scar after a mastectomy (surgery to remove a breast) when there isn't an immediate breast reconstruction. They want to find out if there's a difference in how these scars look and feel over time.

At a glance

Status

Recruiting

Phase

Sponsor

University of British Columbia

Enrolment target

186

Start

09 Dec 2024

Estimated completion

01 Dec 2025

Wound Complication Surgical Wound Infection Post-operative Pain Postoperative Complications Scar

What is this study about?

Imagine you're having surgery, and one of the things you might wonder about is how the scar will look afterwards. This study is all about understanding how different tools used for the very first cut in breast cancer surgery (mastectomy) impact the scar. The doctors are comparing three different ways to make this cut: using a traditional scalpel, using 'standard electrocautery' (which uses heat to cut the skin and stop bleeding at the same time), and using a newer, special tool called the 'PEAK PlasmaBlade'.

The researchers want to see if one of these methods results in a scar that looks better or is less noticeable. While all these methods are considered safe for surgery, it's not yet clear if one is better than another for the final appearance of the scar. This study aims to provide that information. It could help surgeons decide which tools to use in the future to give patients the best possible scar appearance after their operation.

To do this, they will carefully compare the scars of patients who have had their surgery using one of these three methods. Scar appearance will be checked by experts who don't know which tool was used, and patients will also share their own feelings about their scars using a special questionnaire. This study is particularly for those having a mastectomy without immediate breast reconstruction.

Key takeaways

The study compares three surgical tools for mastectomy: scalpel, standard electrocautery, and PEAK PlasmaBlade.
The main goal is to see if one tool leads to a better-looking scar.
Participation involves having scar assessments at 2-4 weeks, 6 months, and 12 months post-surgery.
Patients and scar assessors won't know which tool was used, to ensure unbiased results.
This study is for people having a mastectomy without immediate breast reconstruction.

Who may be eligible?

This study is looking for patients who are scheduled to have a total mastectomy, which means the whole breast is being removed. This might also include surgery to check lymph nodes in the armpit.

However, you wouldn't be able to join the study if you are having immediate breast reconstruction right after your mastectomy. Also, if you have a specific type of breast cancer called inflammatory breast cancer, or if you have a history of developing thick, raised scars (called keloid scars), you wouldn't be suitable. If you have certain connective tissue disorders that affect your skin, or if you've already had surgery at the mastectomy site, or if you're allergic to surgical stitches, you also wouldn't be able to take part. Finally, if there's any sign of an infection at the time of your surgery, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you having a total mastectomy (removal of the entire breast)?
Are you NOT having immediate breast reconstruction at the same time?
Do you NOT have a history of developing thick, raised keloid scars?
Have you NOT had previous surgery at the planned mastectomy site?
Do you NOT have inflammatory breast cancer or certain connective tissue disorders affecting your skin?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't get to choose which surgical tool is used for your initial skin incision – it will be decided randomly, like flipping a coin. After your mastectomy, doctors will carefully assess your scar. This will happen at three different times: about two to four weeks after your surgery, then again at six months, and finally at twelve months. During these follow-up visits, independent experts will look at your scar and you will be asked to fill out a questionnaire (called the SCAR-Q) about how you feel about your scar. The total duration of your participation, including follow-up, would be about one year.

Potential risks and benefits

Taking part in this study might offer the benefit of helping doctors learn more about how surgical tools affect scar appearance, potentially leading to better outcomes for future patients. There are no direct personal benefits guaranteed regarding your own scar outcome beyond standard care. The risks involved are generally those associated with any mastectomy surgery. There are no additional procedural risks from being part of the study; the surgical techniques used are already considered safe. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Mount Saint Joseph Hospital
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is a 'cosmetic outcome' in this study?

It means how the scar looks and feels after surgery – its appearance, texture, and how it affects you.

What is electrocautery?

It's a surgical tool that uses a heated wire to cut tissue and seal small blood vessels at the same time, helping to prevent bleeding.

What is a PEAK PlasmaBlade?

It's a newer surgical tool designed to cut tissue very precisely while causing less heat damage than traditional electrocautery, which might lead to better healing.

Will I know which tool was used on me?

No, you won't know which tool was used because neither you nor the doctors assessing the scar will be told. This helps keep the results unbiased.

How will my scar be assessed?

Independent experts will carefully examine your scar, and you'll also complete a questionnaire about how you feel about your scar's appearance and any symptoms it causes.

How to find out more

Carol K Dingee, MD, FRCSC

cdingee2@providencehealth.bc.ca 6048741141 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.