PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty (PRECISE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Surgical Technologies
ClinicalTrials.gov Identifier:
NCT00943150
First received: July 20, 2009
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Elastosis
Device: PEAK PlasmaBlade
Procedure: Standard of Care (SOC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Two-arm Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Abdominoplasty

Further study details as provided by Medtronic Surgical Technologies:

Primary Outcome Measures:
  • Acute Thermal Injury Depth [ Time Frame: Immediately postoperative ] [ Designated as safety issue: No ]

    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 [ Time Frame: 0, 3, and 6 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Total Drainage Output [ Time Frame: 0 to 10 days postoperatively ] [ Designated as safety issue: No ]
  • Change in Hemoglobin [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    The outcome measure is reported as change in hemoglobin, not the hemoglobin value itself.

  • Narcotic Consumption [ Time Frame: Intraoperative and postoperative (0 to 10 days) ] [ Designated as safety issue: No ]
    Narcotic medications were coded to Fentanyl microgram equivalent units per kilogram.

  • Postoperative Pain Levels [ Time Frame: Postoperative (0 to 10 days) ] [ Designated as safety issue: No ]
    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.

  • Activity Level [ Time Frame: Postoperative (0 to 10 days) ] [ Designated as safety issue: No ]
    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.

  • Diet Volume [ Time Frame: Postoperative (0 to 10 days) ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: December 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEAK PlasmaBlade
The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
Device: PEAK PlasmaBlade
The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
Other Name: PlasmaBlade
Active Comparator: Standard of Care (SOC)
The scalpel and electrocautery will be used for the abdominoplasty procedure.
Procedure: Standard of Care (SOC)
The scalpel and electrocautery will be used for the abdominoplasty procedure.
Other Names:
  • Bovie
  • electrocautery
  • electrosurgery

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.

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943150

Locations
United States, California
El Camino Surgery Center
Mountain View, California, United States, 94040
Sponsors and Collaborators
Medtronic Surgical Technologies
Investigators
Principal Investigator: Howard L Rosenberg, MD El Camino Hospital
  More Information

No publications provided by Medtronic Surgical Technologies

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Surgical Technologies
ClinicalTrials.gov Identifier: NCT00943150     History of Changes
Other Study ID Numbers: PEAK VP-00055
Study First Received: July 20, 2009
Results First Received: November 29, 2012
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Surgical Technologies:
Abdominoplasty
PlasmaBlade
Electrosurgery
PEAK Surgical
Medtronic Advanced Energy
Medtronic

ClinicalTrials.gov processed this record on August 01, 2014