Clinical trial NCT00943150: PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty
Official title: A Prospective, Randomized, Controlled Two-arm Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Abdominoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elastosis
Keywords: Abdominoplasty
PlasmaBlade
Electrosurgery
PEAK Surgical
Medtronic Advanced Energy
Medtronic
Lead sponsor: Medtronic Surgical Technologies
Sponsor class: INDUSTRY
First posted: 2009-07-22
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-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.

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 to cut away this excess skin and fat from the abdomen and the underlying muscles are tightened together with sutures.

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 ear, nose, and throat (ENT) surgery, and has demonstrated significantly reduced serous drainage in tissue reduction surgeries, like abdominoplasty.

A total of twenty (20) human subjects were recruited from the local community against standardized inclusion/exclusion criteria. Once enrolled, each patient underwent placement of three sets of full-thickness comparison incisions in their abdominal skin with a standard scalpel, PlasmaBlade, and traditional electrosurgery at six (6) and three (3) weeks prior to abdominoplasty, and on the day of surgery under general anesthesia. Subjects were then randomized to undergo abdominoplasty with the PlasmaBlade or the SOC (scalpel and traditional electrosurgery). Following abdominoplasty, harvested healed incisions were submitted for histological analysis and burst strength testing and additional data were recorded in the 10 day post-operative period.

Eligibility criteria: Inclusion Criteria:

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

1. Age younger than 25 or greater than 60 years old
2. Anticoagulation therapy which cannot be discontinued
3. Smoking (any kind)
4. Diabetes (any type)
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. Subjects who are pregnant or lactating
12. Currently taking any medication known to affect healing
13. Subjects who are status-post gastric banding or gastric bypass
14. Reproductive age females who will not take acceptable measures to prevent pregnancy during the study.
15. Recent history of abdominal surgery or prior abdominoplasty.
16. Subjects who are known to be HIV or Hepatitis (any) positive
17. Currently enrolled in another investigational device or drug trial
18. Unable to follow instructions or complete follow-up

Primary outcomes:
measure: Acute Thermal Injury Depth
timeFrame: Immediately postoperative
measure: Inflammatory Cell Count
timeFrame: 0, 3, and 6 weeks
Secondary outcomes:
measure: Total Drainage Output
timeFrame: 0 to 10 days postoperatively
measure: Change in Hemoglobin
timeFrame: Intraoperative
measure: Narcotic Consumption
timeFrame: Intraoperative and postoperative (0 to 10 days)
measure: Postoperative Pain Levels
timeFrame: Postoperative (0 to 10 days)
measure: Activity Level
timeFrame: Postoperative (0 to 10 days)
measure: Diet Volume
timeFrame: Postoperative (0 to 10 days)
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: El Camino Surgery Center
state: California
Study officials:
affiliation: El Camino Hospital
name: Howard L Rosenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruidiaz ME, Messmer D, Atmodjo DY, Vose JG, Huang EJ, Kummel AC, Rosenberg HL, Gurtner GC. Comparative healing of human cutaneous surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a standard scalpel. Plast Reconstr Surg. 2011 Jul;128(1):104-111. doi: 10.1097/PRS.0b013e31821741ed.