Harmonic™ vs. Electrocautery in Abdominoplasties
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00506740|
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : August 4, 2015
|Condition or disease||Intervention/treatment|
|Skin and Fat Redundancy and Muscle Diastases||Device: Ultrasonic scalpel Device: monopolar electrosurgery generator and tip|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized, Prospective, Parallel Group Study Comparing the Harmonic™ to Electrocautery in Abdominoplasties|
|Study Start Date :||October 2006|
|Study Completion Date :||June 2007|
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.
Device: Ultrasonic scalpel
A surgical instrument that uses ultrasonic energy that allows both cutting and coagulating at the precise point of application.
Other Names:Device: monopolar electrosurgery generator and tip
- 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 ]
- Total number of hours from drain placement to drain removal [ Time Frame: from drain placement to drain removal ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506740
|United States, Iowa|
|Iowa City Plastic Surgery|
|Coralville, Iowa, United States, 52241|
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267-0558|
|Centro Zimman de Cirugia Plastica|
|Buenos Aires, Argentina, C1425BBE|
|Abteilung für Plastische und Ästhetische Chirurgie|
|Wesseling, Germany, 50389|
|Centro Medico Dalinde|
|Mexico City, Mexico, 06760|
|Principal Investigator:||Drik F Richter, M.D.||Leiter der Abteilung fuer Plastische Chirurgie|