PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty (PRECISE)

A Prospective, Randomized, Controlled Two-arm Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Abdominoplasty

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.

Study Overview

• Status: Completed
• Conditions: Elastosis
• Intervention / Treatment: Device: PEAK PlasmaBlade; Procedure: Standard of Care (SOC)

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Mountain View, California, United States, 94040
      • El Camino Surgery Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEAK PlasmaBlade; The PEAK PlasmaBlade will be used for the abdominoplasty procedure.	Device: PEAK PlasmaBlade; The PEAK PlasmaBlade will be used for the abdominoplasty procedure.; Other Names: PlasmaBlade
Active Comparator: Standard of Care (SOC); The scalpel and electrocautery will be used for the abdominoplasty procedure.	Procedure: Standard of Care (SOC); The scalpel and electrocautery will be used for the abdominoplasty procedure.; Other Names: Bovie; electrocautery; electrosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Thermal Injury Depth	Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures. Acute thermal injury depth was assessed by incising the resected area during the abdominoplasty operation.	Immediately postoperative
Inflammatory Cell Count	Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.	0, 3, and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Drainage Output		0 to 10 days postoperatively
Change in Hemoglobin	The outcome measure is reported as change in hemoglobin, not the hemoglobin value itself.	Intraoperative
Narcotic Consumption	Narcotic medications were coded to Fentanyl microgram equivalent units per kilogram.	Intraoperative and postoperative (0 to 10 days)
Postoperative Pain Levels	Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.	Postoperative (0 to 10 days)
Activity Level	Sum of activity over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their activity level by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.	Postoperative (0 to 10 days)
Diet Volume	Sum of diet volume (i.e., how much food the subject ate) over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their diet volume by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.	Postoperative (0 to 10 days)

Collaborators and Investigators

• Sponsor: Medtronic Surgical Technologies
• Investigators: Principal Investigator: Howard L Rosenberg, MD, El Camino Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 20, 2009
• First Submitted That Met QC Criteria: July 21, 2009
• First Posted (Estimate): July 22, 2009

Study Record Updates

• Last Update Posted (Estimate): January 1, 2013
• Last Update Submitted That Met QC Criteria: November 29, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Abdominoplasty; PlasmaBlade; Electrosurgery; PEAK Surgical; Medtronic Advanced Energy; Medtronic
• Other Study ID Numbers: PEAK VP-00055