A Randomized Control Trial Evaluating the Use of Topical Tranexamic Acid in Bilateral Breast Reduction Surgery to Prevent Bleeding Complications
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- McMaster University
- Enrollment
- 106
- Locations
- 3
- Primary Endpoint
- Hematoma
Study Overview
Brief Summary
Hematoma is a common complication of bilateral breast reduction (BBR) surgery. 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) evaluation TXA use in BBR, for which 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 BBR 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 bilateral breast reduction (BBR). 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 reduction. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
Patients will be randomized on the REDCap system. Their assignment will be made available to research team member, which will be preparing syringes with either TXA or placebo.
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Are 18 years or older;
- •Are undergoing bilateral breast reduction at either Hamilton Health Sciences or St. Joseph's Hospital Hamilton.
Exclusion Criteria
- •Taking therapeutic anticoagulation;
- •Taking antiplatelet drugs;
- •Pregnant or breast feeding;
- •Allergic to TXA;
- •Cannot provide informed consent;
- •Have a documented coagulopathy or bleeding disorder, acquired disturbances of colour vision, subarachnoid hemorrhage, hematuria, irregular menstrual bleeding, or seizure disorder.
Arms & Interventions
Tranexamic Acid
3 grams of tranexamic acid (30mL of 100 mg/mL solution) diluted in 10 mL of normal saline
Intervention: Tranexamic acid (Drug)
Normal Saline
40 mL topical of 0.9% normal saline
Intervention: Normal Saline (Drug)
Outcomes
Primary Outcomes
Hematoma
Time Frame: 2 weeks
Incidence rate of hematoma
Seroma
Time Frame: 2 weeks
Incidence rate of seroma
Secondary Outcomes
- Drain output(24 hours)
- Days with drains(2 weeks)
- Reoperation rate(2 weeks)
- Reintervention rate(2 weeks)
- Imaging findings(2 weeks)