Spots Global Cancer Trial Database for Tranexamic Acid for Alloplastic Breast Reconstruction

Study Description

Brief Summary: Hematoma is a common complication of alloplastic breast reconstruction. This can lead to pain and discomfort experienced by the patient, in addition to greater use of valuable healthcare resources. Previous studies have shown correlation between the use of tranexamic acid (TXA), an anti-fibrinolytic, and reduced post-surgical bleeding complication events. In this randomized control trial (RCT) assessing TXA use in alloplastic breast reconstruction, one breast will be randomized to have TXA applied topically, while the other will have normal saline (NS) placebo applied. The primary objective of this prospective blinded randomized control trial study is to determine if the administration of topical TXA in alloplastic breast reconstruction reduces the incidence of surgical site hematoma compared to placebo within 2 weeks following surgery. The results of this study will be used to inform the design of a larger multicentered RCT on TXA in breast surgery.

Detailed Description: The primary objective of this study is to investigate the use of topical application of tranexamic Acid (TXA) to the surgical wound as a means to decrease hematoma formation compared to placebo in patients undergoing alloplastic breast reconstruction. This project is designed as a single-center RCT to evaluate the effectiveness of topical TXA in this patient population. If enrolled in this study, patients individual breasts will be randomly assigned to one of two treatment groups for to apply to the wound before it is closed. One breast will have an intravenous form of TXA applied topically to the surgical site. The other will be have a topical normal saline solution applied to the wound before closure (a placebo). The patients will have the standard number of drains and postoperative instructions for breast reconstruction. They will follow-up at two weeks time in clinic for assessment, and emergency room visits will be also be evaluated. Standard of care will be practiced with respect to all procedures and visits.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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