ObesityLBLNCT00522171
Harmonic Versus Electro Surgery in Lower Body Lift Procedures
An observational study of Obesity, run by Ethicon Endo-Surgery at 2 sites in 2 countries.
Trial summary
The objective of this study is to determine if the use of The Harmonic™ (an ultrasonic surgical instrument) in Lower Body Lift procedures reduces volume and duration of wound drainage after surgery when compared to Electro Surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- The Harmonic™ ultrasonic scalpel
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2007to Apr 2009
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Post massive weight loss
Who may be able to join
- Subjects eligible for this clinical research study must fulfill all of the following criteria:
- Elect to undergo a Lower Body Lift procedure for post-obesity reasons;
- Able to comprehend and sign the study informed consent form;
- Able to return for all study mandated visits;
- Be a male or female greater than or equal to 18 years of age;
- Obtain medical clearance for a Lower Body Lift procedure according to institutional requirements.
Who cannot join
- Subjects with any of the following criteria are not eligible to participate in this clinical research study:
- American Society Anesthesiologists (ASA) Classification of Physical Status greater than III;
- Current smoker (documented abstinence of 3 months);
- Documented current use of steroids or anti-inflammatory medications (within the past month) and no history of prolonged usage (for 1 month in the past 3 months);
- Diabetes mellitus (requiring treatment within the past year);
- Need of concomitant surgical procedures in which the wound drainage would interconnect with the wound regions studied by the trial (with the exception of liposuction);
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- Presence of ventral or umbilical hernia requiring repair with the use of prosthetic material (e.g. mesh);
- Morbid obesity (Body Mass Index ≥ 40);
- At risk for ischemia due to presence of obstruction of the arterial blood supply or inadequate blood flow;
- Presence of scars that could limit flap advancement or that could not be completely excised;
- Current diagnosis or history of any disease that would impair the healing process;
- Current diagnosis or history of immune system disorders;
- Documented history of bleeding disorders;
- Presence of uncontrolled hypertension;
- Pregnant or lactating;
- Being treated with anticoagulants including aspirin within 7 days prior to surgery (a washout period of 7 days will be required); or
- Participation in any other clinical studies within the past 30 days.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized, Prospective, Parallel Group Study Comparing the Harmonic™ to Electro Surgery in Lower Body Lift Procedures
The objective of this study is to determine if the use of The Harmonic™ (an ultrasonic surgical instrument) in Lower Body Lift procedures reduces volume and duration of wound drainage after surgery when compared to Electro Surgery.
Read the detailed description
Lower Body Lift procedures are performed to correct skin redundancy and muscle diastases caused by significant weight loss, poor skin tone, etc. Lower Body Lift procedures involve a high risk of early complications, including hematomas, seromas, necrosis, and wound-healing problems. The occurrence of these complications may be due in part to the extensive undermining and division of the superficial and the deep arterial systems, done in conventional procedures.
Persistent serous wound drainage and seromas are the most common complications in Lower Body Lift procedures. The rate of serous fluid collection determines the time drains need to remain in place. Although suction drains reduce seroma formation, prolonged use can delay healing, cause injury, and increase the risk of retrograde infection and patient discomfort. Wound drainage has a direct correlation with seroma formation. The loss of protein nutrients and minerals in the serum drained is also a concern with prolonged drainage that can result in healing delays.
The Harmonic™ technology uses ultrasonic energy that allows both cutting and coagulating at the precise point of application. The Harmonic™ has been used since 1992 predominantly in urology and gastro-intestinal surgery (laparoscopic surgery). Significantly reduced serous drainage in a number of general surgery procedures such as superficial and total parotidectomy; thyroidectomy; tonsillectomy; pectoralis major myocutaneous flap dissection; axillary dissection; and lymphadenectomy have been reported with the use of Harmonic™.
The Harmonic™ has also been used in parotidectomy and maxillofacial surgery, but its use has been seldom mentioned in the field of plastic and reconstructive surgery. Recent use of the Harmonic™ has shown promise in plastic and reconstructive surgery in dissection of the pectoralis major myocutaneous flap and total body lifts.
Comparisons: The Harmonic™ vs. Electro Surgery in Lower Body Lift procedures.
- Conditions
- Obesity
- Being tested
- The Harmonic™ ultrasonic scalpel
- Keywords
- Harmonic, Massive Weight Loss, Electro Surgery, Skin and Fat Redundancy after massive weight loss, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Harmonic™ ultrasonic scalpelDevice
Also called Harmonic Technology, Manufacturer: Ethicon Endo-Surgery, Inc., Cincinnati, OH.
A surgical instrument that uses ultrasonic energy that allows both cutting and coagulating at the precise point of application.
| Study group | Role | What they receive |
|---|---|---|
| Electro Surgery | Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body. Receives: Device: The Harmonic™ ultrasonic scalpel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Volume (mL) From the Time of Drain Placement to Time of Drain Removal
Postoperative serous drainage volume was measured in milliliters and defined as the volume of serous fluid collected from the wound drains installed after the study procedure
Measured: From the time of drain placement to time of drain removal (</= 770 hours)
Secondary outcomes (1)
Total Number of Hours From Drain Placement to Drain Removal
Total number of hours from drain placement to drain removal
Measured: From drain placement to drain removal (</= 770 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionFeb 2009
- Study completionApr 2009
Why it stopped: This study was terminated early due to lack of adequate enrollment.
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.
- Other trials for ObesityStudies 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
- Observational
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon Endo-Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Al Aly, MD, Principal investigator, Iowa City Plastic SurgeryDirk Richter, MD, Principal investigator, Facharzt für Plastische Chirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522171
- Sponsor's protocol ID
- CI-06-0009
- Acronym
- LBL
- Status last verified
- Nov 2009
- First submitted
- 27 Aug 2007
- Last updated
- 9 Dec 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Parallel Group Study Comparing the Harmonic™ to Electro Surgery in Lower Body Lift Procedures
- ClinicalTrials.gov ID
- NCT00522171
- Acronym / sponsor ID
- LBL / CI-06-0009
- Conditions
- Obesity
- Keywords
- Harmonic, Massive Weight Loss, Electro Surgery, Skin and Fat Redundancy after massive weight loss, Obesity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: This study was terminated early due to lack of adequate enrollment.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ethicon Endo-SurgeryIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 29 Aug 2007 (estimated)
- Results
- Posted 20 Nov 2009
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 study is to determine if the use of The Harmonic™ (an ultrasonic surgical instrument) in Lower Body Lift procedures reduces volume and duration of wound drainage after surgery when compared to Electro Surgery.
Detailed description
Lower Body Lift procedures are performed to correct skin redundancy and muscle diastases caused by significant weight loss, poor skin tone, etc. Lower Body Lift procedures involve a high risk of early complications, including hematomas, seromas, necrosis, and wound-healing problems. The occurrence of these complications may be due in part to the extensive undermining and division of the superficial and the deep arterial systems, done in conventional procedures.
Persistent serous wound drainage and seromas are the most common complications in Lower Body Lift procedures. The rate of serous fluid collection determines the time drains need to remain in place. Although suction drains reduce seroma formation, prolonged use can delay healing, cause injury, and increase the risk of retrograde infection and patient discomfort. Wound drainage has a direct correlation with seroma formation. The loss of protein nutrients and minerals in the serum drained is also a concern with prolonged drainage that can result in healing delays.
The Harmonic™ technology uses ultrasonic energy that allows both cutting and coagulating at the precise point of application. The Harmonic™ has been used since 1992 predominantly in urology and gastro-intestinal surgery (laparoscopic surgery). Significantly reduced serous drainage in a number of general surgery procedures such as superficial and total parotidectomy; thyroidectomy; tonsillectomy; pectoralis major myocutaneous flap dissection; axillary dissection; and lymphadenectomy have been reported with the use of Harmonic™.
The Harmonic™ has also been used in parotidectomy and maxillofacial surgery, but its use has been seldom mentioned in the field of plastic and reconstructive surgery. Recent use of the Harmonic™ has shown promise in plastic and reconstructive surgery in dissection of the pectoralis major myocutaneous flap and total body lifts.
Comparisons: The Harmonic™ vs. Electro Surgery in Lower Body Lift procedures.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electro Surgery | – | Device: The Harmonic™ ultrasonic scalpelElectro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Post massive weight loss
Key inclusion criteria (6 listed)
- Subjects eligible for this clinical research study must fulfill all of the following criteria:
- Elect to undergo a Lower Body Lift procedure for post-obesity reasons;
- Able to comprehend and sign the study informed consent form;
- Able to return for all study mandated visits;
- Be a male or female greater than or equal to 18 years of age;
Key exclusion criteria (17 listed)
- Subjects with any of the following criteria are not eligible to participate in this clinical research study:
- American Society Anesthesiologists (ASA) Classification of Physical Status greater than III;
- Current smoker (documented abstinence of 3 months);
- Documented current use of steroids or anti-inflammatory medications (within the past month) and no history of prolonged usage (for 1 month in the past 3 months);
- Diabetes mellitus (requiring treatment within the past year);
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 |
|---|---|---|
| The Harmonic™ ultrasonic scalpelAlso: Harmonic Technology, Manufacturer: Ethicon Endo-Surgery, Inc., Cincinnati, OH.A surgical instrument that uses ultrasonic energy that allows both cutting and coagulating at the precise point of application. | Device | Electro Surgery |
Primary outcome
Total Volume (mL) From the Time of Drain Placement to Time of Drain Removal
Time frame: From the time of drain placement to time of drain removal (</= 770 hours)
Postoperative serous drainage volume was measured in milliliters and defined as the volume of serous fluid collected from the wound drains installed after the study procedure
1 secondary outcome
Total Number of Hours From Drain Placement to Drain Removal
Time frame: From drain placement to drain removal (</= 770 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Al Aly, MD principal investigator
Iowa City Plastic Surgery
Dirk Richter, MD principal investigator
Facharzt für Plastische Chirurgie
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Ethicon Endo-Surgery at 2 sites in 2 countries.
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 17 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: stopped early, as of the sponsor's last update on 9 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. 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 20 Nov 2009). 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?
Total Volume (mL) From the Time of Drain Placement to Time of Drain Removal (time frame: From the time of drain placement to time of drain removal (</= 770 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2009.