Surgical Tools for Breast Surgery Scarring

(SCPPB Trial)

Overseen By Carol K Dingee, MD, FRCSC

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Inflammatory breast cancer, Keloid, Connective tissue disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

186 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment PEAK PlasmaBlade for reducing scarring in breast surgery?

Research shows that the PEAK PlasmaBlade causes less tissue damage and results in faster wound healing compared to traditional electrosurgery. It has been found to reduce drain output and duration, and lower the risk of complications in various surgeries, suggesting it may be effective in reducing scarring in breast surgery. ^{1 2 3 4 5}

Is the PEAK PlasmaBlade safe for use in surgeries?

The PEAK PlasmaBlade is generally considered safe for use in surgeries, but there have been reports of device malfunctions and some patient and operator injuries. Most issues were related to device malfunctions, such as coating problems and ignition, while some injuries were due to thermal effects. Educating surgeons on potential risks may help reduce complications. ^{3 4 5 6 7}

How does the PEAK PlasmaBlade treatment differ from other treatments for breast surgery scarring?

The PEAK PlasmaBlade is unique because it uses a special technology that generates less heat compared to traditional electrosurgery, which helps reduce tissue damage and improve wound healing. This makes it potentially more effective in minimizing scarring and complications after breast surgery. ^{1 3 4 5 8}

What is the purpose of this trial?

This study will compare the cosmetic scar result from the use of scalpel, electrocautery, and pulsed electron avalanche knife (PEAK) PlasmaBlade (PPB) for the initial skin incision for total mastectomy procedures without immediate breast reconstruction. It is hypothesized that there will be no significant difference in mastectomy scar cosmesis. The purpose and objectives of this study are: 1. To evaluate and compare the cosmetic scar result from the use of scalpel, standard electrocautery, or PEAK PlasmaBlade for initial incision for total mastectomy procedures without immediate breast reconstruction. 2. To inform future equipment choices for breast surgery including potential elimination of scalpels and their attendant risks.

Research Team

Carol K Dingee, MD, FRCSC

Principal Investigator

Providence Health Care, University of British Columbia

Eligibility Criteria

This trial is for patients undergoing a total mastectomy, with or without axillary surgical staging. It excludes those planning immediate breast reconstruction, diagnosed with inflammatory breast cancer, history of keloid scars or connective tissue disorders affecting the skin, prior incisions at the mastectomy site, known suture allergies, or current infections.

Inclusion Criteria

I have had or will have a complete breast removal surgery, with or without lymph node assessment.

Exclusion Criteria

I am having immediate breast reconstruction.

I have had surgery before at the site where my mastectomy is planned.

I have been diagnosed with inflammatory breast cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo total mastectomy with either scalpel, electrocautery, or PEAK PlasmaBlade

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for scar cosmesis and post-operative complications

12 months

Visits at 2-4 weeks, 6 months, and 12 months

Treatment Details

Interventions

• PEAK PlasmaBlade
• Scalpel and standard electrocautery
• Standard Electrocautery

Trial Overview The study compares cosmetic outcomes from using a scalpel, standard electrocautery, and PEAK PlasmaBlade for initial skin incisions in total mastectomies without immediate reconstruction. The goal is to determine if there's a difference in scar appearance and inform future equipment choices.

Participant Groups

Group I: Standard Electrocautery Experimental Treatment 1 Intervention

Standard electrocautery will be used for the entirety of the surgery, including the initial skin incision.

Group II: PEAK PlasmaBlade Experimental Treatment 1 Intervention

The PEAK PlasmaBlade will be used for the entirety of the surgery, including the initial skin incision.

Group III: Standard of Care Active Control 1 Intervention

The Standard of Care arm will consist of the scalpel for the initial skin incision and further randomization to have completion of the surgery with standard electrocautery or PEAK PlasmaBlade.

PEAK PlasmaBlade is already approved in United States, European Union for the following indications:

Approved in United States as PEAK PlasmaBlade for:

• General surgery
• Orthopedic surgery
• Plastic and reconstructive surgery
• ENT surgery
• Cardiac implantable electronic device procedures

Approved in European Union as PEAK PlasmaBlade for:

• General surgery
• Orthopedic surgery
• Plastic and reconstructive surgery
• ENT surgery

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Findings from Research

The PEAK PlasmaBlade™ device resulted in higher resection weights and significantly lower drain output and duration compared to traditional electrosurgery in a study of 20 patients undergoing bilateral reduction mammaplasty.

This novel low-thermal plasma dissection device appears to cause less thermal damage, suggesting it may improve wound healing outcomes, although wound-healing disorders were still observed in 35% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral reduction mammaplasty with pulsed electron avalanche knife PlasmaBlade™ and conventional electrosurgical surgery: A retrospective, randomised controlled clinical trial. Schlosshauer, T., Kiehlmann, M., Rothenberger, J., et al.[2021]

In a study of 24 patients undergoing body-contouring procedures, the PEAK PlasmaBlade device resulted in significantly lower drain output (61.1 mL) compared to conventional electrosurgery (95.1 mL), indicating better fluid management and potentially improved healing.

The PEAK PlasmaBlade also led to fewer seromas (0 cases) and less thermal damage (40% vs. 70%), suggesting it is a safer option that minimizes tissue damage and enhances postoperative recovery compared to traditional electrosurgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis on the effect of low-thermal plasma dissection device (PEAK PlasmaBlade) versus conventional electro surgery in post-bariatric body-contouring procedures: A retrospective randomised clinical study. Schlosshauer, T., Kiehlmann, M., Ramirez, P., et al.[2021]

In a study of 60 breast cancer surgery patients, the PEAK PlasmaBlade device significantly reduced the incidence of seroma (10%) compared to standard electrosurgery (37.5%), indicating a potential advantage in wound healing.

The study suggests that the PEAK PlasmaBlade may improve surgical outcomes in breast cancer procedures, but further research with larger sample sizes is needed to confirm these findings and explore its effects on other surgical aspects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound healing and postsurgical complications in breast cancer surgery: a comparison between PEAK PlasmaBlade and conventional electrosurgery - a preliminary report of a case series. Chiappa, C., Fachinetti, A., Boeri, C., et al.[2022]

The PEAK PlasmaBlade significantly reduces thermal injury depth by 74% compared to conventional electrosurgery, which may lead to better healing outcomes.

Incisions made with the PlasmaBlade resulted in less inflammation and scar width compared to electrosurgery, showing similar scar width to traditional scalpel incisions, indicating its potential for improved wound healing in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative healing of human cutaneous surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a standard scalpel. Ruidiaz, ME., Messmer, D., Atmodjo, DY., et al.[2022]

The PEAK PlasmaBlade™ significantly reduced procedure time (28.4 minutes) and hospital stay (2.1 days) compared to conventional electrocautery (47.5 minutes and 3.1 days, respectively), indicating greater efficiency in device replacement surgeries.

Using the PEAK PlasmaBlade™ resulted in a lower complication rate (2.4% major complications and no lead damage) compared to conventional methods (6.9% major complications and 5.7% lead damage), highlighting its safety and effectiveness in reducing risks associated with surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An electrical plasma surgery tool for device replacement--retrospective evaluation of complications and economic evaluation of costs and resource use. Kypta, A., Blessberger, H., Saleh, K., et al.[2022]

A review of 384 reports on the PEAK PlasmaBlade 3.0 and 4.0 revealed that 82.1% of adverse events were due to device malfunctions, with the most common issues being delaminated coating and ignition or fire.

While the device is useful in surgeries, it has been linked to patient and operator injuries, highlighting the need for better education on its risks and standardized reporting protocols to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications associated with PEAK PlasmaBlade from 2010 to 2020 from MAUDE. Lee, E., Elzomor, A., Boulos, S., et al.[2022]

In a study of 282 patients undergoing cardiac implantable electronic device (CIED) procedures, the use of the PlasmaBlade™ showed a low overall perioperative complication rate of 3.9%, indicating its safety and feasibility as an alternative to conventional electrocautery.

No lead damage was observed within a 6-month follow-up period, and while there were some complications like device-pocket hematomas and infections, the results suggest that PlasmaBlade™ could be a viable option for CIED surgeries, warranting further comparative studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulsed electron avalanche knife (PEAK) PlasmaBlade™ in pacemaker and defibrillator procedures. Kaya, E., Totzeck, M., Rassaf, T.[2022]

The PEAK PlasmaBlade significantly reduces bleeding during surgery, with a 59% decrease in blood loss compared to traditional scalpel incisions, while also causing less thermal damage to surrounding tissues.

Histological analysis shows that the PlasmaBlade results in similar wound strength and better cosmetic outcomes compared to scalpel incisions, making it a promising tool for precise and safe surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative healing of surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a scalpel. Loh, SA., Carlson, GA., Chang, EI., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Bilateral reduction mammaplasty with pulsed electron avalanche knife PlasmaBlade™ and conventional electrosurgical surgery: A retrospective, randomised controlled clinical trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Comparative analysis on the effect of low-thermal plasma dissection device (PEAK PlasmaBlade) versus conventional electro surgery in post-bariatric body-contouring procedures: A retrospective randomised clinical study. [2021]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Wound healing and postsurgical complications in breast cancer surgery: a comparison between PEAK PlasmaBlade and conventional electrosurgery - a preliminary report of a case series. [2022]

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

Comparative healing of human cutaneous surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a standard scalpel. [2022]

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

An electrical plasma surgery tool for device replacement--retrospective evaluation of complications and economic evaluation of costs and resource use. [2022]

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

Complications associated with PEAK PlasmaBlade from 2010 to 2020 from MAUDE. [2022]

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

Pulsed electron avalanche knife (PEAK) PlasmaBlade™ in pacemaker and defibrillator procedures. [2022]

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

Comparative healing of surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a scalpel. [2022]