Surgical Tools for Breast Surgery Scarring
(SCPPB Trial)
Recruiting in Palo Alto (17 mi)
Overseen byCarol K Dingee, MD, FRCSC
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of British Columbia
Disqualifiers: Inflammatory breast cancer, Keloid, Connective tissue disorder, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
34567How 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.
13458Eligibility 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.
+4 more
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Standard ElectrocauteryExperimental Treatment1 Intervention
Standard electrocautery will be used for the entirety of the surgery, including the initial skin incision.
Group II: PEAK PlasmaBladeExperimental Treatment1 Intervention
The PEAK PlasmaBlade will be used for the entirety of the surgery, including the initial skin incision.
Group III: Standard of CareActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mount Saint Joseph HospitalVancouver, Canada
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Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor
References
Bilateral reduction mammaplasty with pulsed electron avalanche knife PlasmaBlade™ and conventional electrosurgical surgery: A retrospective, randomised controlled clinical trial. [2021]Wound-healing disorders are common complications in bilateral reduction mammaplasty. Traditional electrosurgical devices generate large amounts of thermal energy, often causing extensive thermal-related collateral tissue damage. This study aimed to retrospectively analyse the operative performance of a novel low-thermal plasma dissection device (pulsed electron avalanche knife-PEAK PlasmaBlade™) compared with traditional electrosurgery. Twenty patients with breast hypertrophy were randomly treated with PEAK PlasmaBlade™ on one breast and conventional electrosurgery on the other. Primary outcome measures were resection weight, drain duration, total drainage volume, and drain output on the first postoperative day. 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 output on the first postoperative day (15.9 ± 15.2 mL vs 27.6 ± 23.5 mL; P = .023), and significantly lower drain durations (2.8 ± 1.0 days vs 3.3 ± 1.0 days; P = .030). Mean total drainage volume was lower where breast reduction was performed with PEAK PlasmaBlade™, but this difference was not significant. No major complications occurred, but wound-healing disorders were documented in almost one-third of the patients (35.0%, n = 7). The PEAK PlasmaBlade™ seems to be superior to conventional electrosurgery for bilateral reduction mammaplasty in terms of tissue damage and wound healing.
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]Postoperative wound-healing problems are relatively high in post-bariatric body-contouring procedures, partly because of electrosurgery and the associated thermal tissue damage. This study is a retrospective randomised evaluation of the effect of a low-thermal plasma dissection device (PEAK PlasmaBlade, Medtronic, Minneapolis, Minnesota) in comparison with conventional electrosurgery. A total of 24 patients undergoing upper arm or medial thigh lifting were randomised to PEAK PlasmaBlade on one side and to monopolar electrosurgery on the other side of the same patient. Wounds of 10 patients were examined histologically for acute thermal injury depth. Significantly lower total volume of drain output (61,1 ± 70,2 mL versus 95,1 ± 176,0 mL; P = .04) was found on the PEAK PlasmaBlade side compared with the electrosurgery side. Furthermore, the PEAK PlasmaBlade side showed fewer seromas (no case of seroma versus three seromas in the electrosurgery group) and less thermal damage (40% versus 70%; P = .26). Acute thermal injury depth from the PEAK PlasmaBlade was less than from monopolar electrosurgery (425 ± 171 μm versus 686 ± 1037 μm; P = .631). PEAK PlasmaBlade appears to be superior to traditional monopolar electrosurgery for post-bariatric body-contouring procedures because it demonstrated less tissue damage, lower total volume of drain output, and fewer postoperative seromas resulting in faster wound healing.
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]PEAK PlasmaBlade is a recent and distinctive type of electrosurgical device. Previous studies have already documented some meaningful advantages of this device over conventional electrosurgery. This study compared the use of PEAK PlasmaBlade to standard electrosurgery in mastectomy and breast conservative surgery. The purpose was to test the impact of PEAK PlasmaBlade on the wound-healing process and on postsurgical complications in breast cancer surgery.
Comparative healing of human cutaneous surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a standard scalpel. [2022]The authors investigated thermal injury depth, inflammation, and scarring in human abdominal skin by comparing the histology of incisions made with a standard "cold" scalpel blade, conventional electrosurgery, and the PEAK PlasmaBlade, a novel, low-thermal-injury electrosurgical instrument.
An electrical plasma surgery tool for device replacement--retrospective evaluation of complications and economic evaluation of costs and resource use. [2022]Device replacements bear many potential risks for patients. Electrocautery should be used cautiously because of heating of the cautery tip which may lead to insulation melting. The PEAK PlasmaBlade™ (Medtronic Inc., Minneapolis, MN, USA) uses a novel technology to cut tissue. The objective of this study was to evaluate if this instrument is less destructive and can decrease complications and shorten procedure times.
Complications associated with PEAK PlasmaBlade from 2010 to 2020 from MAUDE. [2022]The pulse-electron avalanche knife (PEAK) PlasmaBlade 3.0 and 4.0 (Medtronic, Minneapolis, MN) is an electrosurgical technology that is widely used in surgery. Our study aimed to summarize device malfunctions, patient injuries, and interventions related to PEAK PlasmaBlade 3.0 and 4.0. The US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of PlasmaBlade adverse events from June 6, 2010, to August 30, 2020. Data were extracted from reports pertaining to PlasmaBlade 3.0 and 4.0. A total of 384 medical device reports were identified, from which 424 adverse events were extracted. Of those, 348 (82.1%) were device malfunctions, 53 (12.5%) were patient injuries, and 23 (5.4%) were operator injuries. Device malfunctions were most frequently caused by delaminated coating (110, 25.9%), followed by ignition or fire (56, 13.2%). Operator injury was most frequently caused by thermal injury (19, 4.5%), followed by laceration (4, 0.9%). Pacemakers (22, 57.9%) were the most common devices causing interference. PEAK PlasmaBlade 3.0 and 4.0 have demonstrated utility during surgeries but are associated with adverse events. Interventions that aim to educate physicians on potential risks may help reduce the incidence of complications. Future studies with standardized reporting protocols are warranted.
Pulsed electron avalanche knife (PEAK) PlasmaBlade™ in pacemaker and defibrillator procedures. [2022]The pulsed electron avalanche knife (PEAK) PlasmaBlade™ is an innovative electrosurgical device that uses a novel technology to cut tissues. It has been proven to be safe and feasible in ear, nose, and throat surgery, but there are only limited data concerning the use of PlasmaBlade™ instead of conventional electrocautery in cardiac implantable electronic device (CIED) procedures except for generator replacements.
Comparative healing of surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a scalpel. [2022]The PEAK PlasmaBlade is a new electrosurgical device that uses pulsed radiofrequency to generate a plasma-mediated discharge along the exposed rim of an insulated blade, creating an effective cutting edge while the blade stays near body temperature.