PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction (PRECISE)

• ClinicalTrials.gov Identifier: NCT00986453
• Recruitment Status: Completed
• First Posted: September 30, 2009
• Results First Posted: January 1, 2013
• Last Update Posted: January 1, 2013
• Sponsor: Medtronic Surgical Technologies
• Information provided by (Responsible Party): Medtronic Surgical Technologies

Study Description

Brief Summary:

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 record post-operative pain, adverse events and skin scarring following surgery; and compare these outcomes to the current standard of care (SOC).

Condition or disease	Intervention/treatment	Phase
Macromastia	Device: PEAK PlasmaBlade; Procedure: Traditional Electrosurgery with scalpel	Not Applicable

Detailed Description:

Bilateral breast reduction is a surgical procedure performed to remove excess breast tissue from both female breasts for therapeutic or cosmetic indications. The purpose of the breast reduction is to decrease the weight of the breasts and restructure the breast tissue for a more favorable appearance. Typically, a scalpel is used for the skin incision and a traditional electrosurgical device is used to cut away any excess tissue.

The PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. The PlasmaBlade has received FDA clearance for use in plastic, general, and ear, nose, and throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit may improve the post-operative outcome of patients undergoing bilateral breast reduction.

A total of forty-five (45) subjects were enrolled into the study. Forty-three (43) underwent bilateral breast reduction, and two (2) subjects were withdrawn prior to surgery. Enrollment and surgeries took place between 18 September 2009 and 12 August 2011. Potential subjects were screened against the inclusion and exclusion criteria of the study protocol and were required to provide informed consent prior to enrollment. Following enrollment, subject operative sites were prospectively randomized to the SOC or PlasmaBlade (PB or PEAK) study groups and scheduled for bilateral breast reduction. Subjects were unaware of which device was used on which breast. Subjects were required to attend two follow-up visits after surgery, approximately one and six weeks following surgery.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Controlled Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
• Study Start Date: January 2010
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: September 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: PlasmaBlade arm; The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.	Device: PEAK PlasmaBlade; The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.; Other Name: PlasmaBlade
Active Comparator: Standard of Care; Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.	Procedure: Traditional Electrosurgery with scalpel; Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.; Other Names: Scalpel; Electrosurgery; SOC

Outcome Measures

Primary Outcome Measures :

1. Postoperative Pain [ Time Frame: 0 to 10 days postoperative ]

   The difference in pain was measured by visual analog scale for 24 hours post-operatively and for 10 post-operative days twice daily between the SOC and PlasmaBlade operative sites.

   Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.

Secondary Outcome Measures :

1. Estimated Blood Loss [ Time Frame: Intraoperative ]
2. Operative Time [ Time Frame: Intraoperative ]
3. Amount of Tissue Removed [ Time Frame: Intraoperative ]
4. Dissection Performance [ Time Frame: Intraoperative ]
   Amount of tissue (g) removed over time (min)

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Age between 20 and 60
2. Physically healthy, stable weight, non-smoker
3. Desiring bilateral breast reduction
4. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
5. Subject must be willing and able to comply with specified follow-up evaluations.
6. Female subjects must either be no longer capable of reproduction, or taking acceptable measures to prevent pregnancy during the study, and have a negative pregnancy test prior to participation in the study.

Exclusion Criteria:

1. Age younger than 20 or greater than 60 years old
2. Anticoagulation therapy which cannot be discontinued
3. Smoking (any kind)
4. Infection (local or systemic)
5. Cognitive impairment or mental illness
6. Severe cardiopulmonary deficiencies
7. Known coagulopathy
8. Immunocompromised
9. Prior history of breast cancer
10. Kidney disease (any type)
11. Currently taking any medication known to affect healing
12. Subjects who are status-post gastric banding or gastric bypass
13. Currently enrolled in another investigational device or drug trial
14. Unable to follow instructions or complete follow-up

Contacts and Locations

Locations

United States, California

Providence St. Joseph's

Burbank, California, United States, 91505

Verdugo Hills Hospital

Glendale, California, United States, 91218

El Camino Hospital

Mountain View, California, United States, 94040

Tri-City Medical Center

Oceanside, California, United States, 92056

Sharp Outpatient Pavilion

San Diego, California, United States, 92123

Rancho Bernardo Surgery Center

San Diego, California, United States, 92128

United States, Ohio

University Hospitals

Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

Medtronic Surgical Technologies

Investigators

• Principal Investigator: Abhay Gupta, MD; Gupta Plastic Surgery
• Principal Investigator: Howard Rosenberg, MD; Accent on Aesthetics Plastic Surgery
• Principal Investigator: Susan Downey, MD; Susan Downey, MD, FACS
• Principal Investigator: Larry Pollack, MD; Del Mar Plastic Surgery
• Principal Investigator: Hooman Soltanian, MD; University Hospital Cleveland

More Information

• Responsible Party: Medtronic Surgical Technologies
• ClinicalTrials.gov Identifier: NCT00986453
• Other Study ID Numbers: PEAK VP-00065
• First Posted: September 30, 2009
• Results First Posted: January 1, 2013
• Last Update Posted: January 1, 2013
• Last Verified: November 2012

Keywords provided by Medtronic Surgical Technologies:

Breast Reduction; PlasmaBlade; Electrosurgery; PEAK Surgical; Medtronic Advanced Energy; Medtronic