Randomized clinical trial of prevention of seroma formation after mastectomy by local methylprednisolone injection

Abstract

Background Seroma formation, the most prevalent postoperative complication after mastectomy, is an inflammatory process that is potentially preventable via local steroid administration. This study investigated the effect of local steroid administration on seroma formation. Methods This was a double-blind randomized placebo-controlled intervention study of a single dose of 80-mg methylprednisolone versus saline on seroma formation after mastectomy. Patients were further classified according to the surgical axillary procedure: mastectomy with sentinel lymph node biopsy (M-+-SLNB) or mastectomy with level I-II axillary lymph node dissection (M-+-ALND). Treatments were administered into the wound cavity via the drain orifice following removal of the drain on the first day after surgery. The primary endpoint was seroma formation; secondary endpoints included the frequency of side-effects and complications. Results A total of 212 women scheduled for mastectomy for primary breast cancer were included. After M-+-SLNB, 32 (46 per cent) of 69 women developed a seroma in the methylprednisolone group, compared with 52 (78 per cent) of 67 in the saline group (P-