Clinical Trial

SEroma Reduction pOst MAstectomy "SEROMA Study"

Study Description

SEroma Reduction pOst MAstectomy "SEROMA Study"

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - Tranexamic Acid 100mg/mL, 20mL topical

Drug: Tranexamic Acid 20 mL TXA (100 mg/mL injection solution, total 2g TXA) applied topically to the mastectomy cavity for 5 minutes before wound closure

Drug - Normal Saline Flush, 0.9%, 20mL topical

Drug: Normal Saline 20 mL 0.9% NaCl (normal saline) applied topically to the mastectomy cavity for 5 minutes before wound closure

Additional Information

Official Study Title

Pilot RCT: Use of Tranexamic Acid (TXA) in Post Mastectomy Patients for Seroma and Hematoma Prevention

Clinical Trial ID

NCT03738527

ParticipAid ID

eERZka