SEroma Reduction pOst MAstectomy SEROMA Study

Study Overview
=================
Brief 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.

Detailed Description
-----------------
The objective of this study is to investigate the novel use of topical application of Tranexamic Acid (TXA) to the surgical wound as a means to decrease seroma and/or hematoma formation compared to placebo in post-mastectomy patients. This project is designed as a single-center pilot RCT to evaluate the feasibility of conducting a formal RCT (multicenter trial including more patients) to evaluate the effectiveness of topical TXA. Patients will be randomly assigned to one of two treatment groups for intraoperative treatment of their mastectomy wound before it is closed. The first group will consist of those who will be treated with the intravenous form of TXA that will be applied to the surface of the mastectomy wound area rather than being injected into a vein. The second group consists of those individuals who will be treated with a topical normal saline solution (a placebo, or inactive substance that looks identical to the study drug but contains no therapeutic ingredients). Both groups will receive the same number of drains and the same post-operative follow-up schedule consisting of visits 2 to 4 weeks and 3 months after the surgery, as well as a last 12 months follow-up. Standard of care will be practiced with respect to all procedures and visits.

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

Conditions
-----------------
Seroma Complicating A Procedure, Hematoma Postoperative, Breast Cancer

Intervention / Treatment
-----------------
* Drug: Tranexamic Acid 100mg/mL, 20mL topical
* Drug: Normal Saline Flush, 0.9%, 20mL topical


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot Randomized Controlled Trial (RCT) with 2 arms: the interventional arm (receiving topical TXA) and the control arm (receiving placebo). Intervention: Topical application of 20 mL of TXA (100 mg/mL injection solution) to the mastectomy cavity Placebo: Topical application of 20 mL of 0.9% NaCl (normal saline) to the mastectomy cavity
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TXA arm<br> | Drug: Tranexamic Acid 100mg/mL, 20mL topical<br>* 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<br>|
| Placebo Comparator: Placebo arm<br> | Drug: Normal Saline Flush, 0.9%, 20mL topical<br>* Drug: Normal Saline 20 mL 0.9% NaCl (normal saline) applied topically to the mastectomy cavity for 5 minutes before wound closure<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Number of patients recruited over the total number of eligible patients screened | About 6 months | 
| Randomization rate | Number of patients randomized over total number recruited | About 9 months | 
| Follow-up visit rate | Number of patients with successful follow-up visits at 3 weeks and 3 months | 3 months | 
| Ability to adhere to protocol | Number of patients randomized to TXA who received TXA vs number of patients randomized to placebo who received the placebo | About 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroma rate | Rate of seroma formation within 3 months following mastectomy in each arm of the study. | 3 months | 
| Seroma volume | Amount of drainage (volume) in patients who did have a seroma, for patients in both arms of the study | 3 months | 
| Seroma aspiration | Aspirated volume in patients who did have a seroma, for patients in both arms of the study | 3 months | 
| Delay in adjuvant treatment | Time (number of weeks) of delay in adjuvant treatment due to seroma/hematoma complication, for patients in both arms of the study | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tranexamic acid, mastectomy, topical, breast cancer, seroma, hematoma