Status:
COMPLETED
PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty
Lead Sponsor:
Medtronic Surgical Technologies
Conditions:
Elastosis
Eligibility:
All Genders
25-60 years
Phase:
NA
Brief Summary
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-o...
Detailed Description
Abdominoplasty is a cosmetic surgical procedure performed to correct abdominal elastosis with skin and fat redundancy. During the procedure, a scalpel and traditional electrosurgical device are used t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00943150
Start Date
December 1 2008
End Date
June 1 2011
Last Update
January 1 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
El Camino Surgery Center
Mountain View, California, United States, 94040