Harmonic™ vs. Electrocautery in Abdominoplasties

Completed · Not applicable

Conditions studied: Skin and Fat Redundancy and Muscle Diastases

In brief

the objective of this study is to determine if the use of The Harmonic™ (an ultrasonic surgical instrument) in abdominolipectomy (tummy tuck)reduces volume and duration of wound drainage after surgery when compared to electrocautery.

Key facts

Study ID

NCT00506740

Run by

Ethicon Endo-Surgery

People needed

70

Starts

2006-10-01

Expected to finish

2007-06-01

Last updated by the study team

2015-08-04

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:
• Elected to undergo a full abdominoplasty procedure for aesthetics or post-obesity reasons
• Able to comprehend and sign the study informed consent form
• Able to return for all study mandated postoperative visits (3-4 days after the removal of drains, as well as 15 ± 2 days, and 30 ± 5 days after surgery); and
• Be greater than or equal to 18 years of age.

You may not qualify if…

• Subjects with any of the following criteria are not eligible to participate in this clinical research study:
• Current smoker
• Current use of steroids
• Diabetes Mellitus
• Need of lipocontouring, other than complementary liposuction of the flanks
• Need of a full body lift (belt lipectomy)
• Need of concomitant surgical procedures via the abdominal flap (other than hernia repair, rectus plication, or liposuction of the flanks) or procedures in which the wound drainage would interconnect with the abdominal wound.
• Presence of ventral or umbilical hernia requiring repair with the use of prosthetic material (e.g., mesh)
• Morbid obesity (BMI ≥ 40)
• At risk for ischemia due to presence of obstruction of the arterial blood supply or inadequate blood flow
• Presence of midline scars that could limit flap advancement that are not limited to the infraumbilical region so they can be completely excised
• Right, left, or bilateral upper quadrant scars, (e.g., previous laparotomy via sub costal incision)
• Heart disease
• History of thromboembolic disease
• Current diagnosis or history of any disease that would impair healing process
• Current diagnosis or history of immune system disorders
• 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.

Where it is running

• Iowa City Plastic Surgery — Coralville, Iowa, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Centro Zimman de Cirugia Plastica — Buenos Aires, Argentina
• Abteilung für Plastische und Ästhetische Chirurgie — Wesseling, Germany
• Centro Medico Dalinde — Mexico City, Mexico

Full record on ClinicalTrials.gov

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