N/A
N=45
PEAK PlasmaBlade 4.0 in Bilateral Breast Reduction
Macromastia
Bottom Line
View on ClinicalTrials.gov: NCT00986453 ↗Enrolled (actual)
45
Serious AEs
1.2%
Results posted
Jan 2013
Primary outcome: Primary: Postoperative Pain — 4.47; 4.66 units on a scale — p=0.4697
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PEAK PlasmaBlade (Device); Traditional Electrosurgery with scalpel (Procedure)
- Age
- Adult · 20+ yrs
- Sex
- Female
- Sponsor
- Medtronic Surgical Technologies
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain |
4.47; 4.66 | 0.4697 |
| SECONDARY Estimated Blood Loss |
56.59; 64.27 | 0.1470 |
| SECONDARY Operative Time |
37.40; 41.55 | 0.0428 sig |
| SECONDARY Amount of Tissue Removed |
685.92; 649.18 | 0.0776 |
| SECONDARY Dissection Performance |
19.81; 15.99 | 0.0002 sig |
Summary
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following surgery; and compare these outcomes to the current standard of care (SOC).
Eligibility Criteria
Inclusion Criteria
- Age between 20 and 60
- Physically healthy, stable weight, non-smoker
- Desiring bilateral breast reduction
- 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 20 or greater than 60 years old
- Anticoagulation therapy which cannot be discontinued
- Smoking (any kind)
- Infection (local or systemic)
- Cognitive impairment or mental illness
- Severe cardiopulmonary deficiencies
- Known coagulopathy
- Immunocompromised
- Prior history of breast cancer
- Kidney disease (any type)
- Currently taking any medication known to affect healing
- Subjects who are status-post gastric banding or gastric bypass
- Currently enrolled in another investigational device or drug trial
- Unable to follow instructions or complete follow-up
Data sourced from ClinicalTrials.gov (NCT00986453). 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.