Clinical trial NCT00522171: Harmonic Versus Electro Surgery in Lower Body Lift Procedures
Official title: A Randomized, Prospective, Parallel Group Study Comparing the Harmonic™ to Electro Surgery in Lower Body Lift Procedures
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Keywords: Harmonic
Massive Weight Loss
Electro Surgery
Skin and Fat Redundancy after massive weight loss
Obesity
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2007-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: PROBABILITY_SAMPLE
Study population: Post massive weight loss

Brief 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.

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.

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.

Primary outcomes:
measure: Total Volume (mL) From the Time of Drain Placement to Time of Drain Removal
timeFrame: From the time of drain placement to time of drain removal (</= 770 hours)
Secondary outcomes:
measure: Total Number of Hours From Drain Placement to Drain Removal
timeFrame: From drain placement to drain removal (</= 770 hours)
Other outcomes:
Locations:
city: Coralville
country: United States
facility: Dr. Al Aly
state: Iowa
city: Wesseling
country: Germany
facility: Abteilung für Plastische und Ästhetische Chirurgie
Study officials:
affiliation: Iowa City Plastic Surgery
name: Al Aly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Facharzt für Plastische Chirurgie
name: Dirk Richter, MD
role: PRINCIPAL_INVESTIGATOR
References: