PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Mastectomy

Stopped early · Not applicable

Conditions studied: Mastectomy

In brief

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).

Key facts

Study ID

NCT00943605

Run by

Medtronic Surgical Technologies

People needed

60

Starts

2009-06-01

Expected to finish

2012-03-01

Last updated by the study team

2013-01-08

Who can join

Age: 20 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Providence St. Joseph's Medical Center — Burbank, California, United States
• El Camino Hospital — Mountain View, California, United States
• Advanced Breast Care — Marietta, Georgia, United States
• St. Joseph Medical Center — Towson, Maryland, United States

Full record on ClinicalTrials.gov

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