A Randomized, Prospective, Parallel Group Study Comparing ...



FORMAL SYNOPSIS

A Randomized, Prospective, Parallel Group Study Comparing the Harmonic™ to Electrocautery in Abdominolipectomies

Dirk F. Richter, MD; Oscar A. Zimman, MD, PhD; José A. León Pérez, MD; Al S. Aly, MD; Alexander Stoff, MD; Fernado Urrutia, MD; Sabina Zimman, MD; Albert Cram, MD; Mario Gutierrez, MSHS; Nfii Ndikintum, PhD

Introduction: 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. Furthermore; the loss of protein nutrients and minerals in the serum drained is also a concern with prolonged drainage that can result in healing delays (1-2).

The Harmonic™ technology (HT) uses ultrasonic energy that allows both cutting and coagulating at the precise point of application, using lower temperatures than those used by electrosurgery or lasers, resulting in minimal lateral thermal tissue damage. The HT has been used since 1992 predominantly in urology and gastro-intestinal surgery (laparoscopic surgery) (3). Less tissue trauma with HT has significantly reduced serous drainage in a number of general surgery procedures such as superficial and total parotidectomy (4); thyroidectomy (5-6); tonsillectomy (7-9); pectoralis major myocutaneous flap dissection (10-11); axillary dissection (12); and lymphadenectomy (13).

The harmonic has also been used in parotidectomy (14-15) and maxillofacial surgery (16), but its use has been seldom mentioned in the field of plastic and reconstructive surgery. Recently use of HT has shown promise in plastic and reconstructive surgery in dissection of the pectoralis major myocutaneous flap (10-11) and lower body lifts (17). Additionally, one of the authors' not yet published data in total lower body lifts using HT demonstrated a significant reduction in drainage compared to electrocoagulation (EC). The aim of this study was to determine if the use of HT in abdominolipectomy reduces volume and duration of postoperative wound drainage when compared to EC.

Method: A prospective, randomized, single blind, parallel group, multi-center study of the HT versus EC for tissue dissection and vascular control in abdominolipectomy was conducted by plastic surgeons located in Germany, Argentina, Mexico, and the U.S. After signing an informed consent, forty-five adults scheduled for full standard abdominolipectomy were randomly allocated to undergo surgery with HT or EC. Forty-five subjects (42 females and 3 males) were enrolled from October 2006 to February 2007 (14 in Germany, 11 in Mexico, 14 in Argentina, and 6 in the U.S.). The group allocation was not revealed to the surgeon until after the induction of sedation/anesthesia. Two closed wound drains were placed in all subjects intraoperatively and serous secretion was measured daily until volume was ≤50 mL/24 hour, at which time the drains were removed. All statistical tests were based on two-side t-test at a significance level of a=0.05. All null hypotheses are stated as no difference in serous drainage volume and duration, and operative time between HT and EC.

Materials: The Harmonic™ (Figure 1) consists of a generator, a hand piece with a connecting cable, and a sharp curved blade (Ethicon Endo-Surgery, Cincinnati, Ohio). The generator is a microprocessor-controlled, high frequency switching power supply that drives the acoustic system in the hand piece. The transducer, found in the hand piece, converts the electrical energy from the generator into mechanical vibration. The ultrasonic vibration is transmitted from the transducer through an extending rod to the attached blade. No electrical energy is conducted through the patient with HT. Monopolar EC was used by all sites (different vendors). All sites used two 19F round Blake™ full fluted silicone drain with J-VAC bulb reservoir for suction of postoperative serious drainage (Ethicon Inc., New Jersey, NY).

results: There was no significant difference in demographic characteristics between the groups. The majority of subjects were either Hispanic (24) or Caucasian (20). Procedurally, no significant differences were observed in weight of excess tissue excised, type of postoperative compression, time to ambulation, and hospitalization time. Serous secretion data were available in forty-four subjects, 23 (12 Hispanic, 2 male) in the HT and 21 (12 Hispanic, 1 male) in the EC group; one subject was excluded from analysis due to noncompliance to postoperative care instructions. Significant reductions in drainage volume and duration of drains were observed for the HT group, with a mean total drainage of near half (46%) of that in the EC group (Table 1). All (100%) drains in the HT group were removed within a week (8 days) compared to 15 (71%) in the EC group (Figure 2). Operative time average with HT averaged approximately 20 minutes longer that with EC, but this did not reached statistical significance (P=0.065). Two cases of seroma requiring aspiration occurred with EC and one with HT. One mild hematoma was reported with HT and two with EC. One case of mild skin-flap ischemia was reported in the HT group but was not related to the use of the device.

Table 1: Summary Statistics for Cumulative Serous Secretions, Duration of Drains and Operative Time and other variables

|Variable |HT (N=23) |EC (N=21) | |

| | | |P value a |

| |Mean ± SD |Range |Mean ± SD |Range | |

|Age |39.7 ± 8.2 |26-53 |40.5 ± 8.4 |31-65 |NS |

|BMI |24.4 ± 3.8 |20-34 |24.6 ± 2.5 |18-30 |NS |

|Weight of excised tissue (grams) |856.2 ± 1121.8 |156-5,768 |735.4 ± 397.7 |329-1855 |NS |

|Cumulative serous secretion (mL) |461.3 ± 219.7 |115.0-860.0 |853.7 ± 587.3 |80.0-2,670.0 |0.008 |

|Duration of drains (hours) |114.5 ± 39.1 |47.8-191.6 |170.6 ± 99.1 |27.3-476.8 |0.023 |

|Operative time (minutes)b |121.2 ± 38.8 |72-217 |102.2 ± 27.2 |53-172 |NS |

|Time to ambulation (hr) |32.7 ± 19.0 |7.3-74.3 |36.8 ± 25.4 |5.4-97.1 |NS |

a p-value is based on t-test for comparing the two surgical device groups.

b For this parameter the N in the EC group = 22

NS= Not Statistically significant (P > 0.05)

Conclusions: This study demonstrates that the use of HT in abdominolipectomies appears safe and, compared to EC, results in near 50% reduction in postoperative serous accumulation and a corresponding 2-day reduction in the use of closed suction drainage. There was a trend suggesting a longer average operative time with HT; however, this difference may be related to inexperience with HT as suggested by the finding that the one study site with previous HT experience reported similar operative times for both groups. Additional studies may be warranted to confirm these results and to investigate additional related outcomes such as healing, risk of retrograde infection, and patient comfort.

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Figure 1. Harmonic™ generator and hand piece with Figure 2. Drain Duration Post Abdominoplasty

Sharp Curved Blade (5mm in diameter, 10cm in length)

REFERENCES

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17. Stoff, A, Reichenberger, MA, and Richter, DF. Comparing the ultrasonically-activated scalpel (Harmonic™) versus high-frequency electrocautery on postoperative serous drainage in massive-weight-loss surgery. Presented at the 37th Annual Meeting of the German Society of Plastics Surgeons, in Aachen, Germany, September 29 through October 2, 2006.

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