160
Participants
Start Date
September 1, 2025
Primary Completion Date
March 1, 2027
Study Completion Date
August 31, 2027
IV TXA
Patients randomized to the IV TXA group will receive intravenous Tranexamic acid during the procedure. The dose will be 1g IV infused over approx. 10 minutes prior to skin closure (dosing of approx. 15 mg/kg, capped at 1 g, which is within safe limits).
Topical TXA
Before wound closure, one 15mm round Jackson-Pratt (JP) drain is placed in each breast pocket, exiting through a lateral chest wall stab incision. The randomized topical TXA intervention is then applied through the drain into the breast after skin closure. The drains will then be temporarily clamped for 20 minutes to allow the TXA to dwell in the tissue and exert local effect. After this the clamp is released, the excess fluid sucked off and the drain connected to a drainage bottle.
Topical saline
Before wound closure, one 15mm round Jackson-Pratt (JP) drain is placed in each breast pocket, exiting through a lateral chest wall stab incision. The randomized saline intervention is then applied through the drain into the breast after skin closure. The drains will then be temporarily clamped for 20 minutes to allow the saline to dwell in the tissue and exert local effect. After this the clamp is released, the excess fluid sucked off and the drain connected to a drainage bottle.
Massachusetts General Hospital
OTHER