Elastosis Clinical Trial
Official title:
A Prospective, Randomized, Controlled Two-arm Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Abdominoplasty
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04769193 -
A Clinical Trial Evaluating the Efficacy of a Skin Cream in Improving Facial Appearance and Skin Elasticity
|
N/A |