Tranexamic Acid Usage in Bilateral Mastectomy to Reduce Post-surgical Drainage
Status:
Recruiting
Trial end date:
2023-07-01
Target enrollment:
Participant gender:
Summary
Tranexamic acid (TxA) is a drug that was approved by the FDA in 1986. It is an
antifibrinolytic drug - this means that it is used to promote blood clotting by preventing
the breakdown of blood clots that your body naturally forms. TxA is very commonly used to
control bleeding in a variety of surgeries, such as orthopedic and gynecologic procedures,
and is available in both the injectable (delivering the drug through the veins) and oral
forms. However, its use is still not commonplace in the setting of elective breast surgery,
because it hasn't been extensively studied in this field. Because it is not currently
FDA-approved for use in elective breast surgery, this would make the drug "investigational"
for this study. Because of its current use in other fields, TxA seems to have a great deal of
potential in reducing the amount of post-operative time that breast drains need to be kept in
place, the frequency of adverse events during wound healing such as bleeding and fluid
accumulation, and overall fluid drainage amount. This would serve to improve the overall
process of post-operative healing following a mastectomy procedure. Currently, the use of TxA
is approved through the injectable route at Northwestern, but it is not approved for
administration by the topical route. Previous studies have shown that TxA given through the
topical route of administration in breast reduction surgery reduced post-surgical drainage
and fluid accumulation. In this study, we'll be investigating the use of 3% (3 grams of TxA
in 100 ml of saline) TxA through the topical route by applying it to the breast wound of one
breast as a direct fluid irrigation. This will be done as a fluid wash, where the TxA will be
in a syringe, and just before wound closure the TxA will be sprayed onto the wound site. The
other breast will undergo the same procedure, but will receive normal saline solution instead
of TxA. The procedure of interest here is a prophylactic bilateral mastectomy, which is a
mastectomy that is performed to prevent the occurrence of breast cancer. The purpose of this
study is to test whether applying TxA topically during wound closure in mastectomy procedures
will affect the quantity of fluid accumulation and bleeding, and the amount of time that
post-operative drains need to be kept in place.
Phase:
Phase 2
Details
Lead Sponsor:
Northwestern University
Collaborators:
Northwestern Memorial Hospital Saint Joseph Hospital, Chicago, Illinois