PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy

Mastectomy Clinical Trial

— PRECISE  

Official title:

A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Mastectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00943605
• Other study ID #: PEAK VP-00074
• Status: Terminated
• Phase: N/A
• First received: July 21, 2009
• Last updated: January 3, 2013
• Start date: June 2009
• Est. completion date: March 2012

Study information

• Verified date: January 2013
• Source: Medtronic Surgical Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objective of this clinical study is to evaluate the incidence of partial skin necrosis following modified-radical mastectomy with or without same-day (two-stage) reconstruction with the PEAK PlasmaBlade 4.0; to monitor and record operative performance, post-operative pain, drain output, and skin scarring following surgery; and to compare these endpoints to the current standard of care (SOC).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age between 20 and 70 years old

2. Physically healthy, stable weight

3. Requiring single or bilateral simple mastectomy, with or without sentinel lymph node biopsy

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 all follow-up evaluations

Exclusion Criteria:

1. Age younger than 20 or greater than 70 years old

2. Anticoagulation therapy which cannot be discontinued

3. Prior external beam or implanted radiotherapy

4. Tobacco use (any kind)

5. Infection (local or systemic)

6. Cognitive impairment or mental illness

7. Severe cardiopulmonary deficiencies

8. Known coagulopathy

9. Immunocompromised

10. Kidney disease (any type)

11. Desiring or requiring same-day breast reconstruction

12. Prior breast reduction or augmentation surgery

13. Unable to follow instructions or complete follow-up

14. Currently taking any medication known to affect healing

15. Subjects who are status-post gastric banding or gastric bypass

16. Currently enrolled in another investigational device or drug trial

17. Time from most recent neoadjuvant therapy less than 4 weeks

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mastectomy

Intervention

Device:
• Scalpel and Traditional Electrosurgery
The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
• PEAK PlasmaBlade
The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.

Locations

Country	Name	City	State
United States	Providence St. Joseph's Medical Center	Burbank	California
United States	Advanced Breast Care	Marietta	Georgia
United States	El Camino Hospital	Mountain View	California
United States	St. Joseph Medical Center	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Surgical Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Serous Drainage (mL) From Time of Drain Placement to Removal.		0 to 10 days postoperatively	No
Primary	Area of Skin Necrosis Measured With a Standard Ruler		1 and 6 weeks postoperative	No
Secondary	Pain Score by Visual Analog Scale, Narcotic Consumption, Operative Time, Time to Surgical Drain Removal		0 to 10 days postoperatively	No