Recruiting

Seroma Reduction

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT03738527

Conditions

Seroma Complicating A Procedure

Hematoma Postoperative

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tranexamic Acid 100mg/mL, 20mL topical

Normal Saline Flush, 0.9%, 20mL topical

Study Details

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.

Conditions

Seroma Complicating A Procedure

Hematoma Postoperative

Breast Cancer

Study ID

NCT03738527

Start date

Oct 7, 2019

Status verified date

Feb, 2021

Completion date

Jul, 2022

Anticipated

Primary completion date

Jan, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: TXA arm

placebo comparator: Placebo arm

Interventions

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

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 measure

  • Recruitment rate [ Time Frame: About 6 months ]
  • Randomization rate [ Time Frame: About 9 months ]
  • Follow-up visit rate [ Time Frame: 3 months ]
  • Ability to adhere to protocol [ Time Frame: About 12 months ]

Central Contacts and Locations

Central contacts

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Juravinski Hospital - Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8V 1C3

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Feb 21, 2021

Last verified

Feb, 2021

Keywords

  • tranexamic acid
  • mastectomy
  • topical
  • breast cancer
  • seroma
  • hematoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2021-02-21.