Harmonic Versus Electro Surgery in Lower Body Lift Procedures (LBL)

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.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Device: The Harmonic™ ultrasonic scalpel

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Germany
  • Wesseling, Germany
    • Abteilung für Plastische und Ästhetische Chirurgie
• United States
  • Iowa
    • Coralville, Iowa, United States, 52241
      • Dr. Al Aly

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Post massive weight loss

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: The Harmonic™ ultrasonic scalpel; A surgical instrument that uses ultrasonic energy that allows both cutting and coagulating at the precise point of application.; Other Names: Harmonic Technology; Manufacturer: Ethicon Endo-Surgery, Inc., Cincinnati, OH.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From the time of drain placement to time of drain removal (</= 770 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Hours From Drain Placement to Drain Removal	Total number of hours from drain placement to drain removal	From drain placement to drain removal (</= 770 hours)

Collaborators and Investigators

• Sponsor: Ethicon Endo-Surgery
• Investigators: Principal Investigator: Al Aly, MD, Iowa City Plastic Surgery; Principal Investigator: Dirk Richter, MD, Facharzt für Plastische Chirurgie

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: August 27, 2007
• First Submitted That Met QC Criteria: August 28, 2007
• First Posted (Estimate): August 29, 2007

Study Record Updates

• Last Update Posted (Estimate): December 9, 2009
• Last Update Submitted That Met QC Criteria: November 30, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Obesity; Harmonic; Massive Weight Loss; Electro Surgery; Skin and Fat Redundancy after massive weight loss
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: CI-06-0009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No