PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty

Completed · Not applicable

Conditions studied: Elastosis

In brief

The objective of this clinical study is to evaluate healing of incisions made with the PEAK PlasmaBlade 4.0 compared to scalpel and traditional electrosurgery (Bovie); to monitor and record key post-operative metrics following abdominoplasty with the PEAK PlasmaBlade 4.0 versus current standard of care (SOC); and to evaluate performance metrics of the PEAK PlasmaBlade 4.0 during abdominoplasty.

Key facts

Study ID

NCT00943150

Run by

Medtronic Surgical Technologies

People needed

20

Starts

2008-12-01

Expected to finish

2011-06-01

Last updated by the study team

2013-01-01

Who can join

Age: 25 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 25 and 60 years old
• Physically healthy, stable weight, non-smoker
• Protruding abdomen, excess fat and skin and/or weak abdominal muscles qualifying for abdominoplasty.
• 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 specified follow-up evaluations.
• 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.

You may not qualify if…

• Age younger than 25 or greater than 60 years old
• Anticoagulation therapy which cannot be discontinued
• Smoking (any kind)
• Diabetes (any type)
• Infection (local or systemic)
• Cognitive impairment or mental illness
• Severe cardiopulmonary deficiencies
• Known coagulopathy
• Immunocompromised
• Kidney disease (any type)
• Subjects who are pregnant or lactating
• Currently taking any medication known to affect healing
• Subjects who are status-post gastric banding or gastric bypass
• Reproductive age females who will not take acceptable measures to prevent pregnancy during the study.
• Recent history of abdominal surgery or prior abdominoplasty.
• Subjects who are known to be HIV or Hepatitis (any) positive
• Currently enrolled in another investigational device or drug trial
• Unable to follow instructions or complete follow-up

Where it is running

• El Camino Surgery Center — Mountain View, California, United States

Full record on ClinicalTrials.gov

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