Harmonic Versus Electro Surgery in Lower Body Lift Procedures

Launched by ETHICON ENDO-SURGERY · Aug 28, 2007

Keywords

ClinConnect Summary

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 f...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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.
• Exclusion Criteria:
• 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.