title: Effectiveness of OK-432 (Sapylin) to reduce seroma formation after axillary lymphadenectomy for breast cancer.
abstract: BACKGROUND
  The occurrence of seroma formation after axillary lymphadenectomy for breast cancer cannot be ignored. Various approaches have been used in an effort to reduce it, but these results are still controversial. We aimed to describe a new method of application of OK-432 (Sapylin, heat-treated Su strain of Streptococcus) to reduce seroma formation after axillary lymphadenectomy for breast cancer and to verify the safety and efficacy of it as a beneficial supplement for conventional surgery.
  
  
  METHODS
  A prospective, randomized analysis of consecutive quadrantectomy or mastectomy plus axillary lymphadenectomy using or not using OK-432 was designed. From July 2010 to November 2011, a total of 111 patients were enrolled in this prospective, randomized study and completed the follow-up. OK-432 applied to the axillary fossa plus placement of closed suction drainage was used in 54 patients (the experimental group); placement of closed suction drainage was used in 57 patients (the control group).
  
  
  RESULTS
  There were no statistical significance between the two groups in terms of age, body mass index, treatment received, tumor size, number of removed lymph nodes, and lymph node status. Postoperative drainage magnitude and duration were significantly reduced in the experimental group (P = 0.008 and 0.003, respectively). One week after hospital discharge, fewer patients developed a palpable seroma in the experimental group: 10 in the experimental group versus 28 in the control group (P = 0.001). Fewer seromas needed aspiration (mean 1 [range 0-3] in the experimental group vs. mean 4 [range 1-5] in the control group; P < 0.001). There were no significant differences in terms of the incidence of complications associated with axillary lymphadenectomy (P = 0.941).
  
  
  CONCLUSIONS
  OK-432 is a feasible and safe option for axillary lymphadenectomy for breast cancer. The use of it does not always prevent seroma formation, but it can reduce drainage magnitude and duration, as well as decrease the incidence of seroma after the removal of drainage. It may be increasingly conducted in day surgery clinics.
authors.affiliation: Department of Surgical Oncology, The First Affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang, People's Republic of China.
authors.forename: Yinlong
authors.initials: Y
authors.lastname: Yang
authors.forename: Erli
authors.initials: E
authors.lastname: Gao
authors.forename: Xinying
authors.initials: X
authors.lastname: Liu
authors.forename: Zhiqiang
authors.initials: Z
authors.lastname: Ye
authors.forename: Yizuo
authors.initials: Y
authors.lastname: Chen
authors.forename: Quan
authors.initials: Q
authors.lastname: Li
authors.forename: Jinmiao
authors.initials: J
authors.lastname: Qu
authors.forename: Xuanxuan
authors.initials: X
authors.lastname: Dai
authors.forename: Ouchen
authors.initials: O
authors.lastname: Wang
authors.forename: Yifei
authors.initials: Y
authors.lastname: Pan
authors.forename: Xiaohua
authors.initials: X
authors.lastname: Zhang
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001365:Axilla; D001943:Breast Neoplasms / Q000601:surgery*; D005260:Female; D006801:Humans; D008197:Lymph Node Excision / Q000009:adverse effects*; D008875:Middle Aged; D010844:Picibanil / Q000009:adverse effects / Q000627:therapeutic use*; D049291:Seroma / Q000209:etiology / Q000517:prevention & control*; D018709:Statistics, Nonparametric; D013396:Suction
chemical_list: D000970:Antineoplastic Agents; D010844:Picibanil