PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty

NCT ID: NCT00943150

Last Updated: 2013-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-06-30

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.

Conditions

Elastosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PEAK PlasmaBlade

The PEAK PlasmaBlade will be used for the abdominoplasty procedure.

Group Type: EXPERIMENTAL

PEAK PlasmaBlade

Intervention Type: DEVICE

The PEAK PlasmaBlade will be used for the abdominoplasty procedure.

Standard of Care (SOC)

The scalpel and electrocautery will be used for the abdominoplasty procedure.

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type: PROCEDURE

The scalpel and electrocautery will be used for the abdominoplasty procedure.

Interventions

PEAK PlasmaBlade

The PEAK PlasmaBlade will be used for the abdominoplasty procedure.

Intervention Type: DEVICE

Standard of Care (SOC)

The scalpel and electrocautery will be used for the abdominoplasty procedure.

Intervention Type: PROCEDURE

Other Intervention Names

PlasmaBlade; Bovie; electrocautery; electrosurgery

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Surgical Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard L Rosenberg, MD

Role: PRINCIPAL_INVESTIGATOR

El Camino Hospital

Locations

El Camino Surgery Center

Mountain View, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21701326 (View on PubMed)

Other Identifiers

PEAK VP-00055

Identifier Type: -

Identifier Source: org_study_id