title: Prospective randomized controlled study to assess the value of a hemostatic and sealing agent for preventing seroma after axillary lymphadenectomy.
abstract: OBJECTIVE
  Postoperative seroma after axillary lymphadenectomy leads to an increased use of resources and an impaired quality of life of patients. This randomized clinical trial was designed to assess the value of a hemostatic and sealing agent for decreasing seroma occurrence after axillary lymphadenectomy.
  
  
  METHODS
  A prospective, randomized, blind study was conducted on 91 axillary lymphadenectomies distributed into a control group (n = 47) and a test group in which a collagen sponge coated with human coagulation factors was used (n = 44). Primary end-points were number of days before removal of axillary drainage, axillary drainage output, and occurrence of seroma, wound infection, haematoma, or wound dehiscence, within 8 weeks of surgery. Bivariate and multivariate analyses on seroma occurrence were performed.
  
  
  RESULTS
  Seroma occurred in 29 patients (31.86%). A significant direct relationship (P = 0.002) was only noted between use of the hemostatic and sealing agent and nonoccurrence of seroma. In the multivariate study, the only variable found to be significantly related to seroma occurrence was use of the above agent (P = 0.046; odds ratio: 3.365 [95%CI: 1.024-11.060]).
  
  
  CONCLUSIONS
  Use of a collagen sponge coated with human coagulation factors following axillary lymphadenectomy was associated to a lower incidence of postoperative seroma. J. Surg. Oncol. 2016;114:423-427. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Department of General Surgery, "Virgen de la Arrixaca" University Hospital, Murcia, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Piñero-Madrona
authors.affiliation: Department of General Surgery, "Virgen de la Arrixaca" University Hospital, Murcia, Spain.
authors.forename: Gregorio
authors.initials: G
authors.lastname: Castellanos-Escrig
authors.affiliation: Department of General Surgery, "Virgen de la Arrixaca" University Hospital, Murcia, Spain.
authors.forename: Jesús
authors.initials: J
authors.lastname: Abrisqueta-Carrión
authors.affiliation: Department of Biostatistics, School of Medicine, University of Murcia, Murcia, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Canteras-Jordana
mesh_terms: D001365:Axilla; D004338:Drug Combinations; D005260:Female; D005340:Fibrinogen / Q000627:therapeutic use*; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D016015:Logistic Models; D008197:Lymph Node Excision / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D049291:Seroma / Q000517:prevention & control*; D013917:Thrombin / Q000627:therapeutic use*
chemical_list: D004338:Drug Combinations; D006490:Hemostatics; C518955:TachoSil; D005340:Fibrinogen; D013917:Thrombin
keywords: axillary lymphadenectomy; axillary lymphadenectomy complications; postlymphadenectomy seroma; sealing agent