ElastosisPRECISENCT00943150
PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty
A study testing PEAK PlasmaBlade in people with Elastosis, run by Medtronic Surgical Technologies at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Elastosis
- What is being tested?
- PEAK PlasmaBlade
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
El Camino Surgery Center
Mountain View, California, 94040
About this study
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.
Read the 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.
- Conditions
- Elastosis
- Being tested
- PEAK PlasmaBlade, Standard of Care (SOC)
- Keywords
- Abdominoplasty, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEAK PlasmaBladeDevice
Also called PlasmaBlade
The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
Standard of Care (SOC)Procedure or surgery
Also called Bovie, electrocautery, electrosurgery
The scalpel and electrocautery will be used for the abdominoplasty procedure.
| Study group | Role | What they receive |
|---|---|---|
| PEAK PlasmaBlade | Experimental | The PEAK PlasmaBlade will be used for the abdominoplasty procedure. Receives: Device: PEAK PlasmaBlade |
| Standard of Care (SOC) | Active comparator | The scalpel and electrocautery will be used for the abdominoplasty procedure. Receives: Procedure: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0, 3, and 6 weeks
Secondary outcomes (6)
Total Drainage Output
Measured: 0 to 10 days postoperatively
Change in Hemoglobin
The outcome measure is reported as change in hemoglobin, not the hemoglobin value itself.
Measured: Intraoperative
Narcotic Consumption
Narcotic medications were coded to Fentanyl microgram equivalent units per kilogram.
Measured: Intraoperative and postoperative (0 to 10 days)
Postoperative Pain Levels
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.
Measured: Postoperative (0 to 10 days)
Activity Level
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.
Measured: Postoperative (0 to 10 days)
Diet Volume
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.
Measured: Postoperative (0 to 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startDec 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ElastosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Surgical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard L Rosenberg, MD, Principal investigator, El Camino Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943150
- Sponsor's protocol ID
- PEAK VP-00055
- Acronym
- PRECISE
- Status last verified
- Nov 2012
- First submitted
- 20 Jul 2009
- Last updated
- 1 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 21701326
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Two-arm Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Abdominoplasty
- ClinicalTrials.gov ID
- NCT00943150
- Acronym / sponsor ID
- PRECISE / PEAK VP-00055
- Conditions
- Elastosis
- Keywords
- Abdominoplasty, PlasmaBlade, Electrosurgery, PEAK Surgical, Medtronic Advanced Energy, Medtronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medtronic Surgical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Posted 1 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEAK PlasmaBlade | Experimental | Device: PEAK PlasmaBladeThe PEAK PlasmaBlade will be used for the abdominoplasty procedure. |
| Standard of Care (SOC) | Active comparator | Procedure: Standard of Care (SOC)The scalpel and electrocautery will be used for the abdominoplasty procedure. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEAK PlasmaBladeAlso: PlasmaBladeThe PEAK PlasmaBlade will be used for the abdominoplasty procedure. | Device | PEAK PlasmaBlade |
| Standard of Care (SOC)Also: Bovie, electrocautery, electrosurgeryThe scalpel and electrocautery will be used for the abdominoplasty procedure. | Procedure or surgery | Standard of Care (SOC) |
Primary outcome
Acute Thermal Injury Depth
Time frame: Immediately postoperative
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
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.
6 secondary outcomes
Total Drainage Output
Time frame: 0 to 10 days postoperatively
Change in Hemoglobin
Time frame: Intraoperative
Narcotic Consumption
Time frame: Intraoperative and postoperative (0 to 10 days)
Postoperative Pain Levels
Time frame: Postoperative (0 to 10 days)
Activity Level
Time frame: Postoperative (0 to 10 days)
Diet Volume
Time frame: Postoperative (0 to 10 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21701326Ruidiaz 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard L Rosenberg, MD principal investigator
El Camino Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEAK PlasmaBlade in people with Elastosis, run by Medtronic Surgical Technologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Thermal Injury Depth (time frame: Immediately postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00943150, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2013.