SEroma Reduction pOst MAstectomy "SEROMA Study"

Sponsor

Hamilton Health Sciences Corporation (Other)

Overall Status

Recruiting

CT.gov ID

NCT03738527

Collaborator

(none)

100

Enrollment

Locations

Arms

32.8

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Seroma Complicating A Procedure Hematoma Postoperative Breast Cancer	Drug: Tranexamic Acid 100mg/mL, 20mL topical Drug: Normal Saline Flush, 0.9%, 20mL topical	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 cavityPilot 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 (Participant, Care Provider)

Masking Description:

Patients will be randomized on the REDCap system. Their assignment will be made available to pharmacy, which will be prepare syringes with either TXA or placebo.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 7, 2019

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TXA arm	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
Placebo Comparator: Placebo arm	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

Arm

Intervention/Treatment

Experimental: TXA arm

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

Placebo Comparator: Placebo arm

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Other complications rate: Hematoma rate [3 months]
Rate of hematoma within 3 months following mastectomy in each arm of the study
Other complications rate: Infection rate [3 months]
Rate of infection within 3 months following mastectomy in each arm of the study
Other complications rate: Wound dehiscence rate [3 months]
Rate of wound dehiscence within 3 months following mastectomy in each arm of the study
Daily output volume [3 months]
Daily drain output (volume), in patients in both arms of the study
Drain discontinuation [3 months]
Time to drain discontinuation (number of days) in patients in both arms of the study
Drain complications [3 months]
Presence of drain complications (leakage, dislodgement, blockage), in patients in both arms of the study
Safety outcomes: rate of thromboembolic events [3 weeks]
Rate of Thromboembolic events within 3 weeks following mastectomy, in patients in both arms of the study
Safety outcomes: rate of myocardial events [3 weeks]
Rate of myocardial events within 3 weeks following mastectomy, in patients in both arms of the study • Rate of other adverse events within 3 weeks following mastectomy
Safety outcomes: rate of other adverse events [3 weeks]
Rate of other adverse events within 3 weeks following mastectomy, in patients in both arms of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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