Clinical trial NCT03738527: SEroma Reduction pOst MAstectomy "SEROMA Study"
Official title: Pilot RCT: Use of Tranexamic Acid (TXA) in Post Mastectomy Patients for Seroma and Hematoma Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Seroma Complicating A Procedure
Hematoma Postoperative
Breast Cancer
Keywords: tranexamic acid
mastectomy
topical
breast cancer
seroma
hematoma
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Recruitment rate
timeFrame: About 6 months
measure: Randomization rate
timeFrame: About 9 months
measure: Follow-up visit rate
timeFrame: 3 months
measure: Ability to adhere to protocol
timeFrame: About 12 months
Secondary outcomes:
measure: Seroma rate
timeFrame: 3 months
measure: Seroma volume
timeFrame: 3 months
measure: Seroma aspiration
timeFrame: 3 months
measure: Delay in adjuvant treatment
timeFrame: 3 months
Other outcomes:
measure: Other complications rate: Hematoma rate
timeFrame: 3 months
measure: Other complications rate: Infection rate
timeFrame: 3 months
measure: Other complications rate: Wound dehiscence rate
timeFrame: 3 months
measure: Daily output volume
timeFrame: 3 months
measure: Drain discontinuation
timeFrame: 3 months
measure: Drain complications
timeFrame: 3 months
measure: Safety outcomes: rate of thromboembolic events
timeFrame: 3 weeks
measure: Safety outcomes: rate of myocardial events
timeFrame: 3 weeks
measure: Safety outcomes: rate of other adverse events
timeFrame: 3 weeks
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital - Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences, McMaster University
name: Nicole Hodgson, MD, MSc, FRCSC
role: PRINCIPAL_INVESTIGATOR
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