INTRODUCTION: 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. MATERIAL AND 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. DISCUSSION: 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. CONCLUSION: As the incidence of post-mastectomy seroma formation is 80%, there is a need for improvement in the prophylaxis and treatment of this condition. FUNDING: not relevant. TRIAL REGISTRATION: 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.
|Tidsskrift||Danish medical journal|
|Status||Udgivet - 1 dec. 2012|