- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00943605
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy (PRECISE)
A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Mastectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Mastectomy is a surgical procedure performed to remove breast tissue that contains cancer, or has a high probability of containing cancer. During the procedure, a scalpel is used for the skin incision and a traditional electrosurgical device is used to cut away the breast tissue from the chest and control bleeding. Once the breast tissue is removed the remaining skin edges are brought together with sutures.
Following mastectomy, the most common complication is persistent serous wound drainage and seroma, a collection of fluid in the closed surgical space. To help prevent this complication a tissue drain is used to remove serous fluid from the surgical space via bulb suction. The rate of serous fluid collection is used to determine the time the drain remains in place. Although suction drains help reduce seroma formation, prolonged use may delay healing, cause injury, and increase the risk of infection and patient discomfort.
The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy to enable precision cutting and coagulating at the point of application, without the thermal damage to surrounding tissues that is normally seen with traditional electrosurgery. The PlasmaBlade has received FDA clearance for use in plastic, general, and ENT surgery, and has demonstrated significantly reduced serous drainage in tissue reduction surgeries, like mastectomy.
This multi-site study was granted IRB approval and conducted between June 2009 and January 2011. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were then required to provide informed consent prior to enrollment. Following enrollment, subjects were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for mastectomy with or without same day reconstruction.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Burbank, California, United States, 94505
- Providence St. Joseph's Medical Center
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Mountain View, California, United States, 94040
- El Camino Hospital
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Georgia
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Marietta, Georgia, United States, 30060
- Advanced Breast Care
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Maryland
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Towson, Maryland, United States, 21204
- St. Joseph Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 20 and 70 years old
- Physically healthy, stable weight
- Requiring single or bilateral simple mastectomy, with or without sentinel lymph node biopsy
- Subject must understand the nature of the procedure and provide written informed consent prior to the procedure
- Subject must be willing and able to comply with all follow-up evaluations
Exclusion Criteria:
- Age younger than 20 or greater than 70 years old
- Anticoagulation therapy which cannot be discontinued
- Prior external beam or implanted radiotherapy
- Tobacco use (any kind)
- Infection (local or systemic)
- Cognitive impairment or mental illness
- Severe cardiopulmonary deficiencies
- Known coagulopathy
- Immunocompromised
- Kidney disease (any type)
- Desiring or requiring same-day breast reconstruction
- Prior breast reduction or augmentation surgery
- Unable to follow instructions or complete follow-up
- Currently taking any medication known to affect healing
- Subjects who are status-post gastric banding or gastric bypass
- Currently enrolled in another investigational device or drug trial
- Time from most recent neoadjuvant therapy less than 4 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard of Care
Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
|
The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
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Experimental: PEAK PlasmaBlade
The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
|
The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total Serous Drainage (mL) From Time of Drain Placement to Removal.
Time Frame: 0 to 10 days postoperatively
|
0 to 10 days postoperatively
|
Area of Skin Necrosis Measured With a Standard Ruler
Time Frame: 1 and 6 weeks postoperative
|
1 and 6 weeks postoperative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain Score by Visual Analog Scale, Narcotic Consumption, Operative Time, Time to Surgical Drain Removal
Time Frame: 0 to 10 days postoperatively
|
0 to 10 days postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Teresa Ponn, MD, Elliot Breast Health Center
- Principal Investigator: Edward Dalton, MD, Elliot Breast Health Center
- Principal Investigator: Richard Fine, MD, Advanced Breast Care
- Principal Investigator: Peter Naruns, MD, Midpeninsula Surgical Associates
- Principal Investigator: Saul Eisenstat, MD, Midpeninsula Surgical Associates
- Principal Investigator: Michael Schultz, MD, St. Joseph Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PEAK VP-00074
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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