Obesity
Conditions
Keywords
Harmonic, Massive Weight Loss, Electro Surgery, Skin and Fat Redundancy after massive weight loss, Obesity
Brief summary
The objective of this study is to determine if the use of The Harmonic™ (an ultrasonic surgical instrument) in Lower Body Lift procedures reduces volume and duration of wound drainage after surgery when compared to Electro Surgery.
Detailed description
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.
Interventions
DEVICEThe Harmonic™ ultrasonic scalpel
A surgical instrument that uses ultrasonic energy that allows both cutting and coagulating at the precise point of application.
Sponsors
Ethicon Endo-Surgery
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects eligible for this clinical research study must fulfill all of the following criteria: * Elect to undergo a Lower Body Lift procedure for post-obesity reasons; * Able to comprehend and sign the study informed consent form; * Able to return for all study mandated visits; * Be a male or female greater than or equal to 18 years of age; * Obtain medical clearance for a Lower Body Lift procedure according to institutional requirements.
Exclusion criteria
Subjects with any of the following criteria are not eligible to participate in this clinical research study: * American Society Anesthesiologists (ASA) Classification of Physical Status greater than III; * Current smoker (documented abstinence of 3 months); * Documented current use of steroids or anti-inflammatory medications (within the past month) and no history of prolonged usage (for 1 month in the past 3 months); * Diabetes mellitus (requiring treatment within the past year); * Need of concomitant surgical procedures in which the wound drainage would interconnect with the wound regions studied by the trial (with the exception of liposuction); * Presence of ventral or umbilical hernia requiring repair with the use of prosthetic material (e.g. mesh); * Morbid obesity (Body Mass Index ≥ 40); * At risk for ischemia due to presence of obstruction of the arterial blood supply or inadequate blood flow; * Presence of scars that could limit flap advancement or that could not be completely excised; * Current diagnosis or history of any disease that would impair the healing process; * Current diagnosis or history of immune system disorders; * Documented 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 within the past 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Volume (mL) From the Time of Drain Placement to Time of Drain Removal | From the time of drain placement to time of drain removal (</= 770 hours) | Postoperative serous drainage volume was measured in milliliters and defined as the volume of serous fluid collected from the wound drains installed after the study procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Hours From Drain Placement to Drain Removal | From drain placement to drain removal (</= 770 hours) | Total number of hours from drain placement to drain removal |
Countries
Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Electro Surgery 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. | 15 |
| Harmonic® Technology Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.
The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.
These devices were not modified from their commercially available specifications. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Electro Surgery | Harmonic® Technology | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 30 Participants |
| Age Continuous | 39.13 years STANDARD_DEVIATION 10.239 | 38.13 years STANDARD_DEVIATION 8.105 | 38.63 years STANDARD_DEVIATION 9.088 |
| Region of Enrollment Germany | 8 participants | 7 participants | 15 participants |
| Region of Enrollment United States | 7 participants | 8 participants | 15 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 15 | 11 / 15 |
| serious Total, serious adverse events | 1 / 15 | 1 / 15 |
Outcome results
Primary
Total Volume (mL) From the Time of Drain Placement to Time of Drain Removal
Postoperative serous drainage volume was measured in milliliters and defined as the volume of serous fluid collected from the wound drains installed after the study procedure
Time frame: From the time of drain placement to time of drain removal (</= 770 hours)
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electro Surgery | Total Volume (mL) From the Time of Drain Placement to Time of Drain Removal | 2163.03 milliliter | Standard Deviation 756.295 |
| Harmonic® Technology | Total Volume (mL) From the Time of Drain Placement to Time of Drain Removal | 1863.60 milliliter | Standard Deviation 1471.39 |
Secondary
Total Number of Hours From Drain Placement to Drain Removal
Total number of hours from drain placement to drain removal
Time frame: From drain placement to drain removal (</= 770 hours)
Population: terminated study