Skin and Fat Redundancy and Muscle Diastases Clinical Trial
Official title:
A Randomized, Prospective, Parallel Group Study Comparing the Harmonic™ to Electrocautery in Abdominoplasties
the objective of this study is to determine if the use of The Harmonic™ (an ultrasonic surgical instrument) in abdominolipectomy (tummy tuck)reduces volume and duration of wound drainage after surgery when compared to electrocautery.
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.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Supportive Care