title: Modified radical mastectomy: a pilot clinical trial comparing the use of conventional electric scalpel and harmonic scalpel.
abstract: BACKGROUND
  The aim of this study was to compare the rates of local postoperative complications among women undergoing modified radical mastectomy with an electric scalpel (ES) or a harmonic scalpel (HS). It is thought that HS use has less postoperative complications, mainly seroma formation.
  
  
  METHODS
  This study was a prospective non-randomised clinical trial (NCT01391988) among consecutive patients, performed in parallel. Patients underwent modified radical mastectomy using an HS or ES. We analysed the following operative variables: time, blood loss and seroma volume drainage. Postoperative complications, including seroma, flap necrosis, haematoma and infection were evaluated on the 7th and 14th days.
  
  
  RESULTS
  Forty-six patients underwent a MRM with ES and 49 with HS; no differences were observed between the groups. The rate of local complications was 29% in the HS group and 52% in the ES group (p = 0.024). The rates of seroma (16.3% versus 28.3%; p = 0.161), necrosis (4.1% vs. 21.7%; p = 0.013; OR = 0.15), haematoma (2.0% vs. 8.7%; p = 0.195) and infection (2.0% vs. 6.5%; p = 0.351) were lower in the HS group. Adding the findings of all comparative studies using HSs in MRM to the seroma rates in the current study, the seroma rate, expressed as a categorical variable, did not decrease with HS. Seroma was present in 60/219 cases using an HS and in 69/239 cases utilising an ES (p = 0.72). Based on a multivariate analysis, HS decreased the risk of skin necrosis (p = 0.015).
  
  
  CONCLUSIONS
  HSs do not decrease the seroma rate. However, this method may be useful in skin sparing mastectomy because it decreases skin flap necrosis.
authors.affiliation: Department of Breast and Reconstructive Surgery, Barretos Cancer Hospital, Brazil.
authors.forename: Gustavo Henrique Fabri Pereira
authors.initials: GH
authors.lastname: Ribeiro
authors.forename: Ligia Maria
authors.initials: LM
authors.lastname: Kerr
authors.forename: Raphael Luiz
authors.initials: RL
authors.lastname: Haikel
authors.forename: Stela Verzinhasse
authors.initials: SV
authors.lastname: Peres
authors.forename: Angelo Gustavo Zucca
authors.initials: AG
authors.lastname: Matthes
authors.forename: Rodrigo Augusto
authors.initials: RA
authors.lastname: Depieri Michelli
authors.forename: Antônio
authors.initials: A
authors.lastname: Bailão
authors.forename: José Humberto Tavares Guerreiro
authors.initials: JH
authors.lastname: Fregnani
authors.forename: René Aloísio da Costa
authors.initials: RA
authors.lastname: Vieira
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D005260:Female; D006801:Humans; D015411:Mastectomy, Modified Radical / Q000295:instrumentation* / Q000379:methods; D008875:Middle Aged; D009336:Necrosis; D010865:Pilot Projects; D011183:Postoperative Complications / Q000209:etiology; D018709:Statistics, Nonparametric; D013524:Surgical Flaps / Q000473:pathology; D013525:Surgical Instruments