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

Medtronic

Status: Completed

Conditions: Elastosis

Treatments: Device: PEAK PlasmaBlade; Procedure: Standard of Care (SOC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00943150

PEAK VP-00055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

PEAK PlasmaBlade

Experimental group

Description:

The PEAK PlasmaBlade will be used for the abdominoplasty procedure.

Treatment:

Device: PEAK PlasmaBlade

Standard of Care (SOC)

Active Comparator group

Description:

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

Treatment:

Procedure: Standard of Care (SOC)