PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty

Elastosis Clinical Trial

— PRECISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943150
• Other study ID #: PEAK VP-00055
• Status: Completed
• Phase: N/A
• First received: July 20, 2009
• Last updated: November 29, 2012
• Start date: December 2008
• Est. completion date: June 2011

Study information

• Verified date: November 2012
• Source: Medtronic Surgical Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elastosis

Intervention

Device:
• PEAK PlasmaBlade
The PEAK PlasmaBlade will be used for the abdominoplasty procedure.

Procedure:
• Standard of Care (SOC)
The scalpel and electrocautery will be used for the abdominoplasty procedure.

Locations

Country	Name	City	State
United States	El Camino Surgery Center	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Surgical Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Total Drainage Output		0 to 10 days postoperatively	No
Secondary	Change in Hemoglobin	The outcome measure is reported as change in hemoglobin, not the hemoglobin value itself.	Intraoperative	No
Secondary	Narcotic Consumption	Narcotic medications were coded to Fentanyl microgram equivalent units per kilogram.	Intraoperative and postoperative (0 to 10 days)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No