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SEroma Reduction pOst MAstectomy "SEROMA Study" (SEROMA)

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ClinicalTrials.gov Identifier: NCT03738527
Recruitment Status : Recruiting
First Posted : November 13, 2018
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Hamilton Health Sciences Corporation

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : October 7, 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

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





Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: About 6 months ]
    Number of patients recruited over the total number of eligible patients screened

  2. Randomization rate [ Time Frame: About 9 months ]
    Number of patients randomized over total number recruited

  3. Follow-up visit rate [ Time Frame: 3 months ]
    Number of patients with successful follow-up visits at 3 weeks and 3 months

  4. Ability to adhere to protocol [ Time Frame: 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 :
  1. Seroma rate [ Time Frame: 3 months ]
    Rate of seroma formation within 3 months following mastectomy in each arm of the study.

  2. Seroma volume [ Time Frame: 3 months ]
    Amount of drainage (volume) in patients who did have a seroma, for patients in both arms of the study

  3. Seroma aspiration [ Time Frame: 3 months ]
    Aspirated volume in patients who did have a seroma, for patients in both arms of the study

  4. Delay in adjuvant treatment [ Time Frame: 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:
  1. Other complications rate: Hematoma rate [ Time Frame: 3 months ]
    Rate of hematoma within 3 months following mastectomy in each arm of the study

  2. Other complications rate: Infection rate [ Time Frame: 3 months ]
    Rate of infection within 3 months following mastectomy in each arm of the study

  3. Other complications rate: Wound dehiscence rate [ Time Frame: 3 months ]
    Rate of wound dehiscence within 3 months following mastectomy in each arm of the study

  4. Daily output volume [ Time Frame: 3 months ]
    Daily drain output (volume), in patients in both arms of the study

  5. Drain discontinuation [ Time Frame: 3 months ]
    Time to drain discontinuation (number of days) in patients in both arms of the study

  6. Drain complications [ Time Frame: 3 months ]
    Presence of drain complications (leakage, dislodgement, blockage), in patients in both arms of the study

  7. Safety outcomes: rate of thromboembolic events [ Time Frame: 3 weeks ]
    Rate of Thromboembolic events within 3 weeks following mastectomy, in patients in both arms of the study

  8. Safety outcomes: rate of myocardial events [ Time Frame: 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


  9. Safety outcomes: rate of other adverse events [ Time Frame: 3 weeks ]
    Rate of other adverse events within 3 weeks following mastectomy, in patients in both arms of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03738527


Contacts
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Contact: Isabelle Duchesnay, M.D. 905-521-2100 ext #4843 isabelle.duchesnay@medportal.ca

Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Juravinski Hospital - Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 1C3
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
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Principal Investigator: Nicole Hodgson, MD, MSc, FRCSC Hamilton Health Sciences, McMaster University
Publications:

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Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT03738527    
Other Study ID Numbers: 5271
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hamilton Health Sciences Corporation:
tranexamic acid
mastectomy
topical
breast cancer
seroma
hematoma
Additional relevant MeSH terms:
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Hematoma
Seroma
Hemorrhage
Pathologic Processes
Inflammation
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants