Breast cancer is the second most common cancer among women in the United States.
Mastectomy procedures are often performed to treat breast cancer, and may either be done
prophylactically or therapeutically. Women with either a strong family history of breast
cancer and/or a positive mutation for the breast cancer susceptibility genes BRCA1 or
BRCA2 may elect to undergo a prophylactic mastectomy, in which one or both breasts are
removed. Such procedures have been found to reduce the risk of developing breast cancer
in these individuals by 90-95%. This process often begins with an individual who has a
family member or relative that has tested positive for a BRCA mutation or developed
breast cancer. Female family members may then choose to undergo screening to identify
whether they carry such a genetic mutation themselves, and if any family member screens
positive for the mutation, one may solicit a plastic surgeon for the mastectomy to
prevent future breast cancer occurrence. Additionally, women may elect to undergo a
mastectomy after the development of cancer in one or both breasts. In the event of cancer
development in one breast, patients may choose to undergo a bilateral mastectomy
therapeutically in the breast with cancer and prophylactically in the breast without
cancer to prevent future cancer development in the non-cancer breast.
During mastectomy procedures, tumescent solution is commonly used for regional anesthesia
and reduction of blood loss through potent vasoconstriction. Tumescent solution is an
infiltration solution (a formula consisting of epinephrine, lidocaine in Lactated
Ringer's solution diluted in saline) that usually contains 0.05% lidocaine and
1:1,000,000 epinephrine. While there are several studies investigating various modified
recipe of tumescent solution during bilateral risk-reducing mastectomy (BRRM) with the
goal of reducing perioperative bleeding, the results remain inconsistent.
In this study, the use of TxA in bilateral mastectomy in a cohort of female patients will
be investigated. TxA is an anti-fibrinolytic agent commonly used to control trauma and
menstrual bleeding, as well as in routine surgical procedures. In prior studies, TxA has
been shown to reduce mortality due to adverse bleeding events by one-third1. In addition,
TxA mechanism-of-action has been shown to exert an immunomodulatory effect that results
in reduced infection rates independent of its effect on reduction of blood loss4. Because
of this, TxA has become an attractive agent for use in surgery to control bleeding during
procedures and post-surgical fluid accumulation at the wound site. However, its use is
still not commonplace in the setting of elective breast surgery.
During breast surgery, agents such as tumescent solution are commonly administered to
reduce peri-operative bleeding and post-surgical blood and fluid accumulation. Following
surgery, drainage systems such as Jackson-Pratt drains are placed within the breast to
allow for fluid removal and prevent the incidence of infection, hematoma, and seroma. To
date, few studies have investigated the perioperative use of TxA during breast surgery to
reduce post-surgical fluid drainage and reduction of corresponding adverse events - as a
result, the investigators believe that there is a great deal of potential in this
investigation to inform future surgical practices in this field and to improve patients'
quality-of-life. In this study, the investigators will conduct a prospective study of
female patients undergoing bilateral mastectomy to determine the effect of TxA
administration in reducing post-surgical breast drainage and indwelling time and
preventing adverse fluid accumulation-related events.
