Elastosis
Conditions
Keywords
Abdominoplasty, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
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.
Interventions
DEVICEPEAK PlasmaBlade
The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
PROCEDUREStandard of Care (SOC)
The scalpel and electrocautery will be used for the abdominoplasty procedure.
Sponsors
Medtronic Surgical Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Total Drainage Output | 0 to 10 days postoperatively | — |
| 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. |
| 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. |
| Change in Hemoglobin | Intraoperative | The outcome measure is reported as change in hemoglobin, not the hemoglobin value itself. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PEAK PlasmaBlade The PEAK PlasmaBlade will be used for the abdominoplasty procedure. | 10 |
| Standard of Care (SOC) The scalpel and electrocautery will be used for the abdominoplasty procedure. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | PEAK PlasmaBlade | Standard of Care (SOC) | Total |
|---|---|---|---|
| Age Continuous | 42.11 years FULL_RANGE 9.41 | 44.40 years FULL_RANGE 10.72 | 43.26 years |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 10 | 3 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: Immediately postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAK PlasmaBlade | Acute Thermal Injury Depth | 195 micrometers | Standard Deviation 127 |
| Electrocautery | Acute Thermal Injury Depth | 763 micrometers | Standard Deviation 208 |
p-value: <0.001Regression, Linear
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.
Time frame: 0, 3, and 6 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| PEAK PlasmaBlade | Inflammatory Cell Count | CD3+ 0 weeks | 93 cells per square millimeter |
| PEAK PlasmaBlade | Inflammatory Cell Count | CD3+ 3 weeks | 207 cells per square millimeter |
| PEAK PlasmaBlade | Inflammatory Cell Count | CD3+ 6 weeks | 216 cells per square millimeter |
| PEAK PlasmaBlade | Inflammatory Cell Count | CD68+ 0 weeks | 71 cells per square millimeter |
| PEAK PlasmaBlade | Inflammatory Cell Count | CD68+ 3 weeks | 201 cells per square millimeter |
| PEAK PlasmaBlade | Inflammatory Cell Count | CD68+ 6 weeks | 232 cells per square millimeter |
| Electrocautery | Inflammatory Cell Count | CD68+ 6 weeks | 185 cells per square millimeter |
| Electrocautery | Inflammatory Cell Count | CD3+ 0 weeks | 120 cells per square millimeter |
| Electrocautery | Inflammatory Cell Count | CD68+ 0 weeks | 75 cells per square millimeter |
| Electrocautery | Inflammatory Cell Count | CD68+ 3 weeks | 263 cells per square millimeter |
| Electrocautery | Inflammatory Cell Count | CD3+ 3 weeks | 239 cells per square millimeter |
| Electrocautery | Inflammatory Cell Count | CD3+ 6 weeks | 223 cells per square millimeter |
| Scalpel | Inflammatory Cell Count | CD3+ 3 weeks | 171 cells per square millimeter |
| Scalpel | Inflammatory Cell Count | CD3+ 6 weeks | 196 cells per square millimeter |
| Scalpel | Inflammatory Cell Count | CD68+ 6 weeks | 202 cells per square millimeter |
| Scalpel | Inflammatory Cell Count | CD68+ 0 weeks | 87 cells per square millimeter |
| Scalpel | Inflammatory Cell Count | CD3+ 0 weeks | 138 cells per square millimeter |
| Scalpel | Inflammatory Cell Count | CD68+ 3 weeks | 173 cells per square millimeter |
Comparison: CD3+ at 0 weeksp-value: 0.33ANOVA
Comparison: CD3+ at 3 weeksp-value: 0.02ANOVA
Comparison: CD3+ at 6 weeksp-value: 0.71ANOVA
Comparison: CD68+ at 0 weeksp-value: 0.67ANOVA
Comparison: CD68+ at 3 weeksp-value: 0.01ANOVA
Comparison: CD68+ at 6 weeksp-value: 0.48ANOVA
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.
Time frame: Postoperative (0 to 10 days)
Population: One subject was removed from the analysis of secondary variables owing to a protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAK PlasmaBlade | Activity Level | 452.78 units on a scale | Standard Deviation 139.57 |
| Electrocautery | Activity Level | 347.00 units on a scale | Standard Deviation 165.92 |
p-value: 0.999Exact Wilcoxon test
Secondary
Change in Hemoglobin
The outcome measure is reported as change in hemoglobin, not the hemoglobin value itself.
Time frame: Intraoperative
Population: One subject was removed from the analysis of secondary variables owing to a protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAK PlasmaBlade | Change in Hemoglobin | -0.68 g/dL | Standard Deviation 1.03 |
| Electrocautery | Change in Hemoglobin | -1.62 g/dL | Standard Deviation 1.21 |
p-value: 0.0898Exact Wilcoxon test
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.
Time frame: Postoperative (0 to 10 days)
Population: One subject was removed from the analysis of secondary variables owing to a protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAK PlasmaBlade | Diet Volume | 701.11 units on a scale | Standard Deviation 160.97 |
| Electrocautery | Diet Volume | 470.50 units on a scale | Standard Deviation 243.35 |
p-value: 0.0412Exact Wilcoxon test
Secondary
Narcotic Consumption
Narcotic medications were coded to Fentanyl microgram equivalent units per kilogram.
Time frame: Intraoperative and postoperative (0 to 10 days)
Population: One subject was removed from the analysis of secondary variables owing to a protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEAK PlasmaBlade | Narcotic Consumption | Intraoperative | 3.82 Fentanyl microgram units/g | Standard Deviation 2.26 |
| PEAK PlasmaBlade | Narcotic Consumption | Postoperative (0 to 10 days) | 2.39 Fentanyl microgram units/g | Standard Deviation 2.26 |
| Electrocautery | Narcotic Consumption | Intraoperative | 4.92 Fentanyl microgram units/g | Standard Deviation 1.72 |
| Electrocautery | Narcotic Consumption | Postoperative (0 to 10 days) | 3.33 Fentanyl microgram units/g | Standard Deviation 2.75 |
Comparison: Intraoperative narcotic use comparisonp-value: 0.076Exact Wilcoxon test
Comparison: Postoperative narcotic use comparisonp-value: 0.59Exact Wilcoxon test
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.
Time frame: Postoperative (0 to 10 days)
Population: One subject was removed from the analysis of secondary variables owing to a protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAK PlasmaBlade | Postoperative Pain Levels | 2.15 units on a scale | Standard Deviation 1.05 |
| Electrocautery | Postoperative Pain Levels | 3.30 units on a scale | Standard Deviation 2.72 |
p-value: 0.4589Exact Wilcoxon test
Secondary
Total Drainage Output
Time frame: 0 to 10 days postoperatively
Population: One subject was removed from the analysis of secondary variables owing to a protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAK PlasmaBlade | Total Drainage Output | 654.89 mL | Standard Deviation 217.74 |
| Electrocautery | Total Drainage Output | 887.70 mL | Standard Deviation 325.79 |
p-value: 0.1128Exact Wilcoxon rank-sum test