SEroma Reduction pOst MAstectomy "SEROMA Study"

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a pilot study to evaluate the feasibility of conducting a larger trial to determine if the use of intraoperative topical tranexamic acid (TXA) decreases the rate of post-operative hematomas and seromas in breast cancer patients after their mastectomy. In other words, the investigators want to determine if applying TXA inside the surgical wound before it is closed helps reduce blood or serous fluid accumulation at the operative site. Dependent on the results of this study, a further larger trial may or may not take place.

Post-operative seromas and hematomas are common complications of mastectomy surgery not only leading to infection, discomfort, wound dehiscence or emergency room visits; they also delay in some instances post-operative adjuvant radiotherapy. Establishing whether or not topical TXA is an effective strategy to decrease those complications can potentially impact positively the breast cancer treatment.

To achieve this aim, this randomized pilot study will first determine whether a larger multicenter study if feasible. This study will replicate a formal randomized trial at a smaller scale in a single center in order to assess the recruitment and randomization process, as well as provide preliminary results for our research question.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Breast cancer diagnosis

• Age 18-80

• Fluent in English

• Female undergoing mastectomy with or without axillary intervention

Exclusion Criteria:

• Immediate reconstruction

• Pre-surgical radiation

• Known allergy to TXA

• Known thromboembolic disease

• High-risk of thromboembolism and/or receiving anticoagulants

• History of myocardial infarction (MI), transient ischemic attack or stroke within the last year

• History of subarachnoid hemorrhage

• Premenopausal women with irregular menstrual bleeding of unknown cause

• Acquired disturbances of colour vision

• Hematuria with renal cause

• History of seizure disorder

• Pregnant or breastfeeding