N/A
N=20
PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty
Elastosis
Bottom Line
View on ClinicalTrials.gov: NCT00943150 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Acute Thermal Injury Depth — 195; 763 micrometers — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PEAK PlasmaBlade (Device); Standard of Care (SOC) (Procedure)
- Age
- Adult · 25+ yrs
- Sex
- All
- Sponsor
- Medtronic Surgical Technologies
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Thermal Injury Depth |
195; 763 | <0.001 sig |
| PRIMARY Inflammatory Cell Count |
93; 120; 138; 207; 239; 171 | 0.33 |
| SECONDARY Total Drainage Output |
654.89; 887.70 | 0.1128 |
| SECONDARY Change in Hemoglobin |
-0.68; -1.62 | 0.0898 |
| SECONDARY Narcotic Consumption |
3.82; 4.92; 2.39; 3.33 | 0.0760 |
| SECONDARY Postoperative Pain Levels |
2.15; 3.30 | 0.4589 |
| SECONDARY Activity Level |
452.78; 347.00 | 0.999 |
| SECONDARY Diet Volume |
701.11; 470.50 | 0.0412 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00943150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.