PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty
PRECISE
A Prospective, Randomized, Controlled Two-arm Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Abdominoplasty
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 20, 2009
CompletedFirst Posted
Study publicly available on registry
July 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
January 1, 2013
CompletedJanuary 1, 2013
November 1, 2012
2.5 years
July 20, 2009
November 29, 2012
November 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Total Drainage Output
0 to 10 days postoperatively
Change in Hemoglobin
Intraoperative
Narcotic Consumption
Intraoperative and postoperative (0 to 10 days)
Postoperative Pain Levels
Postoperative (0 to 10 days)
Activity Level
Postoperative (0 to 10 days)
- +1 more secondary outcomes
Study Arms (2)
PEAK PlasmaBlade
EXPERIMENTALThe PEAK PlasmaBlade will be used for the abdominoplasty procedure.
Standard of Care (SOC)
ACTIVE COMPARATORThe scalpel and electrocautery will be used for the abdominoplasty procedure.
Interventions
The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
The scalpel and electrocautery will be used for the abdominoplasty procedure.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
El Camino Surgery Center
Mountain View, California, 94040, United States
Related Publications (1)
Ruidiaz ME, Messmer D, Atmodjo DY, Vose JG, Huang EJ, Kummel AC, Rosenberg HL, Gurtner GC. Comparative healing of human cutaneous surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a standard scalpel. Plast Reconstr Surg. 2011 Jul;128(1):104-111. doi: 10.1097/PRS.0b013e31821741ed.
PMID: 21701326DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Swain, PhD
- Organization
- Medtronic Surgical Technologies
Study Officials
- PRINCIPAL INVESTIGATOR
Howard L Rosenberg, MD
El Camino Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2009
First Posted
July 22, 2009
Study Start
December 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
January 1, 2013
Results First Posted
January 1, 2013
Record last verified: 2012-11