Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT00943605
Status:
TERMINATED
Last Update Posted:
2013-01-08
First Post:
2009-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy
Sponsor:
Medtronic Surgical Technologies
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Mastectomy
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Termination due to acquisition of PEAK Surgical by Medtronic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECISE
Brief 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).
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: