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

Primary Purpose

Obesity

Status
Terminated
Phase
Locations
International
Study Type
Observational
Intervention
The Harmonic™ ultrasonic scalpel
Sponsored by
Ethicon Endo-Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Obesity focused on measuring Harmonic, Massive Weight Loss, Electro Surgery, Skin and Fat Redundancy after massive weight loss, Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dr. Al Aly
  • Abteilung für Plastische und Ästhetische Chirurgie

Arms of the Study

Arm 1

Arm Type

Arm Label

Electro Surgery

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total Number of Hours From Drain Placement to Drain Removal
Total number of hours from drain placement to drain removal

Full Information

First Posted
August 27, 2007
Last Updated
November 30, 2009
Sponsor
Ethicon Endo-Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT00522171
Brief Title
Harmonic Versus Electro Surgery in Lower Body Lift Procedures
Acronym
LBL
Official Title
A Randomized, Prospective, Parallel Group Study Comparing the Harmonic™ to Electro Surgery in Lower Body Lift Procedures
Study Type
Observational

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated early due to lack of adequate enrollment.
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ethicon Endo-Surgery

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Harmonic, Massive Weight Loss, Electro Surgery, Skin and Fat Redundancy after massive weight loss, Obesity

7. Study Design

Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electro Surgery
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
The Harmonic™ ultrasonic scalpel
Other Intervention Name(s)
Harmonic Technology, Manufacturer: Ethicon Endo-Surgery, Inc., Cincinnati, OH.
Intervention Description
A surgical instrument that uses ultrasonic energy that allows both cutting and coagulating at the precise point of application.
Primary Outcome Measure Information:
Title
Total Volume (mL) From the Time of Drain Placement to Time of Drain Removal
Description
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
Time Frame
From the time of drain placement to time of drain removal (</= 770 hours)
Secondary Outcome Measure Information:
Title
Total Number of Hours From Drain Placement to Drain Removal
Description
Total number of hours from drain placement to drain removal
Time Frame
From drain placement to drain removal (</= 770 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Study Population Description
Post massive weight loss
Sampling Method
Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Al Aly, MD
Organizational Affiliation
Iowa City Plastic Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dirk Richter, MD
Organizational Affiliation
Facharzt für Plastische Chirurgie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Al Aly
City
Coralville
State/Province
Iowa
ZIP/Postal Code
52241
Country
United States
Facility Name
Abteilung für Plastische und Ästhetische Chirurgie
City
Wesseling
Country
Germany

12. IPD Sharing Statement

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Harmonic Versus Electro Surgery in Lower Body Lift Procedures

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