- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00506740
Harmonic™ vs. Electrocautery in Abdominoplasties
A Randomized, Prospective, Parallel Group Study Comparing the Harmonic™ to Electrocautery in Abdominoplasties
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Abdominolipectomy is performed to correct abdominal skin and fat redundancy and muscle diastases. Persistent serous wound drainage and seromas are the most common complications in abdominolipectomy. 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 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. electrocautery in abdominolipectomy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, C1425BBE
- Centro Zimman de Cirugia Plastica
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Wesseling, Germany, 50389
- Abteilung für Plastische und Ästhetische Chirurgie
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Mexico City, Mexico, 06760
- Centro Medico Dalinde
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Iowa
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Coralville, Iowa, United States, 52241
- Iowa City Plastic Surgery
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Ohio
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Cincinnati, Ohio, United States, 45267-0558
- University of Cincinnati
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Electrocautery
Elesurgical instruments are used to cut and coagulate tissue using alternatig electric current focusing intense heat at the surgical site.
In electrosurgery, the patient is included in the circuit and current enters the patient's body.
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A surgical instrument that uses ultrasonic energy that allows both cutting and coagulating at the precise point of application.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total volume (mL) from the time of drain placement to time of drain removal.
Time Frame: from the time of drain placement to time of drain removal
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from the time of drain placement to time of drain removal
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Total number of hours from drain placement to drain removal
Time Frame: from drain placement to drain removal
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from drain placement to drain removal
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Drik F Richter, M.D., Leiter der Abteilung fuer Plastische Chirurgie
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CI-06-0002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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