PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty

Not Applicable

Completed

Conditions: Elastosis

Interventions: Device: PEAK PlasmaBlade
Procedure: Standard of Care (SOC)

Registration Number: NCT00943150

Lead Sponsor: Medtronic Surgical Technologies

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

Age between 25 and 60 years old
Physically healthy, stable weight, non-smoker
Protruding abdomen, excess fat and skin and/or weak abdominal muscles qualifying for abdominoplasty.
Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
Subject must be willing and able to comply with specified follow-up evaluations.
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

Age younger than 25 or greater than 60 years old
Anticoagulation therapy which cannot be discontinued
Smoking (any kind)
Diabetes (any type)
Infection (local or systemic)
Cognitive impairment or mental illness
Severe cardiopulmonary deficiencies
Known coagulopathy
Immunocompromised
Kidney disease (any type)
Subjects who are pregnant or lactating
Currently taking any medication known to affect healing
Subjects who are status-post gastric banding or gastric bypass
Reproductive age females who will not take acceptable measures to prevent pregnancy during the study.
Recent history of abdominal surgery or prior abdominoplasty.
Subjects who are known to be HIV or Hepatitis (any) positive
Currently enrolled in another investigational device or drug trial
Unable to follow instructions or complete follow-up

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEAK PlasmaBlade	PEAK PlasmaBlade	The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
Standard of Care (SOC)	Standard of Care (SOC)	The scalpel and electrocautery will be used for the abdominoplasty procedure.

Primary Outcome Measures

Name	Time	Method
Acute Thermal Injury Depth	Immediately postoperative	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.
Inflammatory Cell Count	0, 3, and 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Total Drainage Output	0 to 10 days postoperatively
Change in Hemoglobin	Intraoperative	The outcome measure is reported as change in hemoglobin, not the hemoglobin value itself.
Narcotic Consumption	Intraoperative and postoperative (0 to 10 days)	Narcotic medications were coded to Fentanyl microgram equivalent units per kilogram.
Postoperative Pain Levels	Postoperative (0 to 10 days)	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.
Activity Level	Postoperative (0 to 10 days)	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.
Diet Volume	Postoperative (0 to 10 days)	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.