Harmonic Versus Electro Surgery in Lower Body Lift Procedures

Stopped early

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00522171

Run by

Ethicon Endo-Surgery

People needed

30

Starts

2007-09-01

Expected to finish

2009-04-01

Last updated by the study team

2009-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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);
• 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.

Where it is running

• Dr. Al Aly — Coralville, Iowa, United States
• Abteilung für Plastische und Ästhetische Chirurgie — Wesseling, Germany

Full record on ClinicalTrials.gov

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