An interventional study of Ultrasonic scalpel and monopolar electrosurgery generator and tip in Skin and Fat Redundancy and Muscle Diastases, sponsored by Ethicon Endo-Surgery. Completed at 5 sites in 4 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-04.
Sponsored by Ethicon Endo-Surgery · Not applicable, Interventional, and Supportive care
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.
41 studies on the registry are indexed under Diastasis, Muscle; 9 are open to participants now.
This study's enrollment of 70 is above the median of 48 across 31 interventional studies indexed under Diastasis, Muscle.
Browse Diastasis, Muscle studies →Ethicon Endo-Surgery is the lead sponsor of 47 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
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Subjects eligible for this clinical research study must fulfill all of the following criteria:
Exclusion Criteria:
Subjects with any of the following criteria are not eligible to participate in this clinical research study:
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 · Device: monopolar electrosurgery generator and tip
A surgical instrument that uses ultrasonic energy that allows both cutting and coagulating at the precise point of application.
Also known as: 1) Sharp Curved Blade (HF105), 2) Generator (GEN04), 3) Hand Piece (HP054), Manufacturer: Ethicon Endo-Surgery, Inc., Cincinnati, OH.
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
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Ethicon Endo-Surgery