Harmonic Versus Electro Surgery in Lower Body Lift Procedures (LBL)
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|ClinicalTrials.gov Identifier: NCT00522171|
Recruitment Status : Terminated (This study was terminated early due to lack of adequate enrollment.)
First Posted : August 29, 2007
Results First Posted : November 20, 2009
Last Update Posted : December 9, 2009
|Condition or disease||Intervention/treatment|
|Obesity||Device: The Harmonic™ ultrasonic scalpel|
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|
|Actual Enrollment :||30 participants|
|Official Title:||A Randomized, Prospective, Parallel Group Study Comparing the Harmonic™ to Electro Surgery in Lower Body Lift Procedures|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||April 2009|
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.
- 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 (</= 770 hours) ]
- Total Number of Hours From Drain Placement to Drain Removal [ Time Frame: From drain placement to drain removal (</= 770 hours) ]
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): NCT00522171
|United States, Iowa|
|Dr. Al Aly|
|Coralville, Iowa, United States, 52241|
|Abteilung für Plastische und Ästhetische Chirurgie|
|Principal Investigator:||Al Aly, MD||Iowa City Plastic Surgery|
|Principal Investigator:||Dirk Richter, MD||Facharzt für Plastische Chirurgie|