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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores which surgical tool—scalpel, electrocautery (a tool that cuts using electric current), or PEAK PlasmaBlade (a precise cutting tool using plasma)—results in the best-looking scar after a total mastectomy without immediate breast reconstruction. Researchers aim to determine if any tool produces significantly better or worse scarring, potentially influencing future breast surgery techniques. The trial is open to patients undergoing a total mastectomy, provided they are not having immediate reconstruction and do not have conditions like inflammatory breast cancer or a history of keloid scars. As an unphased trial, it offers patients the chance to contribute to advancements in surgical techniques that could enhance cosmetic outcomes for future patients.

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 prior data suggests that these surgical tools are safe for breast surgery?

Research shows that the PEAK PlasmaBlade, a tool for making surgical cuts, is generally safe. Studies have found that it can reduce heat damage and swelling, which may aid healing. Reports of the device malfunctioning are rare.

Standard electrocautery, another surgical tool, is also considered safe. However, one study found it might increase the risk of fluid buildup under the skin after surgery. Despite this, it remains widely used and well-tolerated in many surgeries.

Both the PEAK PlasmaBlade and standard electrocautery are proven methods for making precise cuts with minimal risk. Safety data supports their continued use, though each has its own considerations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the surgical tools being tested for breast surgery scarring because they offer potential improvements over traditional methods. Unlike the standard use of scalpels and standard electrocautery, the PEAK PlasmaBlade delivers precise, cool incisions using pulsed plasma technology, which may reduce tissue damage and improve healing. This innovative approach contrasts with standard electrocautery, which uses heat to cut and cauterize, potentially leading to more scarring. By comparing these methods, researchers hope to find out if the PEAK PlasmaBlade can offer better cosmetic outcomes and quicker recovery for patients.

What evidence suggests that these surgical tools are effective for improving mastectomy scar cosmesis?

Research has shown that the PEAK PlasmaBlade, which participants in this trial may receive, might help reduce post-surgery complications. One study with 60 breast cancer patients found that the PEAK PlasmaBlade lowered the chance of fluid buildup (seroma) to 10% compared to regular tools. This tool operates at a cooler temperature than standard electrocautery, potentially causing less harm to nearby tissues. Meanwhile, standard electrocautery, another option in this trial, can make surgeries quicker and easier than using traditional scalpels. Both tools offer advantages, so the best choice depends on what is most important for the surgery's success. ^{1 4 6 7 8}

Who Is on the Research Team?

Carol K Dingee, MD, FRCSC

Principal Investigator

Providence Health Care, University of British Columbia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06191159

Cosmetic Outcome of Electrocautery, Scalpel and PEAK ... This study will compare the cosmetic scar result from the use of scalpel, electrocautery, and pulsed electron avalanche knife (PEAK) PlasmaBlade (PPB) for ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7949310/

Bilateral reduction mammaplasty with pulsed electron ... Breasts treated with PEAK PlasmaBlade™ had significantly higher resection weights (728.0 ± 460.1 g vs 661.6 ± 463.4 g; P = .038), significantly lower drain ...

3. withpower.com withpower.com/trial/phase-scarring-2024-b66a1

Surgical Tools for Breast Surgery Scarring (SCPPB Trial) In a study of 60 breast cancer surgery patients, the PEAK PlasmaBlade device significantly reduced the incidence of seroma (10%) compared to standard ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6121169/

Wound healing and postsurgical complications in breast ... With the present study we would like to assess the effectiveness of PEAK PlasmaBlade, compared to standard electrosurgery, not only in mastectomy but also in ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00986453?tab=table

PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during bilateral breast reduction; to monitor and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7949418/

Comparative analysis on the effect of low‐thermal plasma ... We also want to visually evaluate the scarring and aesthetic outcomes caused by PEAK PlasmaBlade 6 months after surgery, which is an important parameter for ...

7. trialx.com trialx.com/clinical-trials/listings/316064/cosmetic-outcome-of-electrocautery-scalpel-and-peak-plasmablade-for-surgical-breast-incisions/

Cosmetic Outcome of Electrocautery, Scalpel and PEAK ... Scalpel, electrocautery, and PEAK PlasmaBlade (PPB) have all been shown to be safe techniques for surgical incision, but no study has proven the ...

8. medtronic.com medtronic.com/se-sv/healthcare-professionals/products/spinal-orthopaedic/electrosurgical/peak-plasmablade-device-orthopaedic/clinical.html

Clinical Studies Related to the PEAK PlasmaBlade Device ... Specific to the PEAK PlasmaBlade device, clinical research has demonstrated significant reduction in thermal injury depth, inflammatory response and healed scar ...