PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Elastosis

Intervention / Treatment
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* Device: PEAK PlasmaBlade
* Procedure: Standard of Care (SOC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEAK PlasmaBlade<br>The PEAK PlasmaBlade will be used for the abdominoplasty procedure. | Device: PEAK PlasmaBlade<br>* The PEAK PlasmaBlade will be used for the abdominoplasty procedure.<br>* Other names: PlasmaBlade;|
| Active Comparator: Standard of Care (SOC)<br>The scalpel and electrocautery will be used for the abdominoplasty procedure. | Procedure: Standard of Care (SOC)<br>* The scalpel and electrocautery will be used for the abdominoplasty procedure.<br>* Other names: electrosurgery;|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominoplasty, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic