title: Local injection of methylprednisolonacetat to prevent seroma formation after mastectomy.
abstract: BACKGROUND
  This study served the following three purposes: To evaluate the prophylactic effect against seroma of a single dose of steroid in the mastectomy cavity, to evaluate the thesis that there is a connection between subclinical bacterial colonization and seroma formation and to evaluate if a simple urine stix test can detect postmastectomy infection.
  
  
  METHODS
  This was a double-blinded and randomized study of injection of methylprednisolonacetate versus saline in the mastectomy cavity at the time of drain removal. A total of 160 females were enrolled after mastectomy. The study parameters were as follows: seroma volume, number of seroma punctures, frequency of clinical infections, degree and type of subclinical colonization, complications and evaluation of the microbiological results of the stix test with automatically read glucose, ketones, blood, pH, protein, nitrite and leucocytes. The degree of inflammation was monitored by measurement of 15 cytokines in each sample of seroma fluid. The study was initiated in August 2010 and is expected to run for three years.
  
  
  CONCLUSIONS
  Some reports have concluded that seroma formation forms part of postsurgical inflammation. Steroids are effective against inflammation and accumulation of fluid at the surgical site after several types of surgery and have also proved valuable in the treatment of seroma formation. In the present study, the prophylactic effect of steroids on seroma formation is investigated.
  
  
  CONCLUSIONS
  As the incidence of postmastectomy seroma formation is 80%, there is a need for improvement in the prophylaxis and treatment of this condition.
  
  
  BACKGROUND
  not relevant.
  
  
  BACKGROUND
  Medicines Agency The EudraCT number 2009-016650-40 has been issued for your Sponsor's Protocol Code Number 23837. Data protection agency J.no. F.750.75-2. The study is perfomed in collaboration with the GCP Unit, capital Region, Bispebjerg Hospital under the EudraCT number: 2009-016650-40.
authors.affiliation: Department F of Breast Surgery, Herlev Hospital, 2730 Herlev, Denmark. cax@dadlnet.dk
authors.forename: Christen Kirk
authors.initials: CK
authors.lastname: Axelsson
authors.forename: Gro Maria
authors.initials: GM
authors.lastname: Quamme
authors.forename: Charlotte
authors.initials: C
authors.lastname: Lanng
authors.forename: Pal Bela
authors.initials: PB
authors.lastname: Szecsi
authors.forename: Minea Brusgaard
authors.initials: MB
authors.lastname: Mortensen
authors.forename: Birgitte
authors.initials: B
authors.lastname: Wegeberg
authors.forename: Magnus
authors.initials: M
authors.lastname: Arpi
authors.forename: Marianne
authors.initials: M
authors.lastname: Lingskov
authors.forename: Mette Stub
authors.initials: MS
authors.lastname: Puglich
authors.forename: Mette
authors.initials: M
authors.lastname: Okholm
mesh_terms: D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D016207:Cytokines / Q000378:metabolism; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007239:Infections / Q000175:diagnosis*; D008408:Mastectomy / Q000009:adverse effects*; D008775:Methylprednisolone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077555:Methylprednisolone Acetate; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D049291:Seroma / Q000378:metabolism / Q000382:microbiology* / Q000517:prevention & control*
chemical_list: D000893:Anti-Inflammatory Agents; D016207:Cytokines; D000077555:Methylprednisolone Acetate; D008775:Methylprednisolone