Does a Single Steroid Injection Reduce the Formation of Postmastectomy Seroma
Status:
Unknown status
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
Background Seroma formation is a common problem after mastectomy. The incidence various
between 30% to 92%. It is often an ongoing problem after removal of the suction drain, and
repeated skin puncture is necessary to remove the seroma. In addition to many ambulatory
visits this also leads to an increased risk of infection, and the adjuvant treatment can be
delayed for several weeks
Different procedures have been tried to avoid seroma formation. Among these are for ex. :
immobilisation of the arm and shoulder after mastectomy, different drain regimens, closing of
the dead space of the cavity, different chemical substances as thrombin, tranexamacid and
fibrin. Non of these results has been successful.
Seroma formation is most likely the result of the inflammatory response due to wound healing.
In the seroma fluid several factors have been detected that support this assumption. These
factors are: high levels of IgG, leucocytes, granulocytes, proteinases, proteinases
inhibitors, different kinds of cytokines ( tPA, uPA,, uPAR, PAI-1, PAI-2, IL-6 og IL-1).
On the basis of this, an inhibition of the inflammatory response might result in a decrease
of seroma formation, and perhaps improve quality of life after mastectomy.
Steroids inhibit the inflammatory response for example by inhibition of the cytokine
function. It has been shown that a high single dose of steroid infusion (30mg/kg solu-medrol)
inhibits the normal IL 6 response after colon resection. Newer studies have shown that even
at a lower dose the inflammatory response is inhibited. In several studies of head and neck
surgery the oedema in surgical area is reduced after a single dose of 125 mg solumedrol. It
is precisely this effect of reduced fluid formation we want to obtain in our study. We have
therefore chosen to use a single dose of 125 mg of solumedrol in this study. Even at the
largest single dose of glucocorticoids there have not been seen any increasing in surgical
complications.
The aim of the study: To find out whether single dose of glucocorticoid can reduce the seroma
formation after mastectomy
Study design : A randomised pilot study, with 2 x 20 patients. 125 mg solumedrol is given 1,5
hours before surgery in 20 patients, and the other 20 patients are the control group
Inclusion criteria: Women with primary breast cancer, undergoing a mastectomy with either
sentinel node biopsy or complete axillary dissection.