Study Results
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Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2019-10-07
2022-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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
PREVENTION
DOUBLE
Study Groups
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TXA arm
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 arm
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Age 18-80
* Fluent in English
* Female undergoing mastectomy with or without axillary intervention
Exclusion Criteria
* 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
18 Years
80 Years
FEMALE
No
Sponsors
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Hamilton Health Sciences Corporation
OTHER
Responsible Party
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Principal Investigators
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Nicole Hodgson, MD, MSc, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences, McMaster University
Locations
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St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Juravinski Hospital - Hamilton Health Sciences
Hamilton, Ontario, Canada
Countries
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Central Contacts
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References
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Porter KA, O'Connor S, Rimm E, Lopez M. Electrocautery as a factor in seroma formation following mastectomy. Am J Surg. 1998 Jul;176(1):8-11. doi: 10.1016/s0002-9610(98)00093-2.
Pogson CJ, Adwani A, Ebbs SR. Seroma following breast cancer surgery. Eur J Surg Oncol. 2003 Nov;29(9):711-7. doi: 10.1016/s0748-7983(03)00096-9.
van Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17.
Coveney EC, O'Dwyer PJ, Geraghty JG, O'Higgins NJ. Effect of closing dead space on seroma formation after mastectomy--a prospective randomized clinical trial. Eur J Surg Oncol. 1993 Apr;19(2):143-6.
Baker E, Piper J. Drainless mastectomy: Is it safe and effective? Surgeon. 2017 Oct;15(5):267-271. doi: 10.1016/j.surge.2015.12.007. Epub 2016 Feb 19.
He XD, Guo ZH, Tian JH, Yang KH, Xie XD. Whether drainage should be used after surgery for breast cancer? A systematic review of randomized controlled trials. Med Oncol. 2011 Dec;28 Suppl 1:S22-30. doi: 10.1007/s12032-010-9673-2. Epub 2010 Sep 9.
Ker K, Roberts I, Shakur H, Coats TJ. Antifibrinolytic drugs for acute traumatic injury. Cochrane Database Syst Rev. 2015 May 9;2015(5):CD004896. doi: 10.1002/14651858.CD004896.pub4.
Gupta K, Rastogi B, Krishan A, Gupta A, Singh VP, Agarwal S. The prophylactic role of tranexamic acid to reduce blood loss during radical surgery: A prospective study. Anesth Essays Res. 2012 Jan-Jun;6(1):70-3. doi: 10.4103/0259-1162.103378.
Perel P, Ker K, Morales Uribe CH, Roberts I. Tranexamic acid for reducing mortality in emergency and urgent surgery. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD010245. doi: 10.1002/14651858.CD010245.pub2.
Oertli D, Laffer U, Haberthuer F, Kreuter U, Harder F. Perioperative and postoperative tranexamic acid reduces the local wound complication rate after surgery for breast cancer. Br J Surg. 1994 Jun;81(6):856-9. doi: 10.1002/bjs.1800810621.
Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013 Jul 23;2013(7):CD010562. doi: 10.1002/14651858.CD010562.pub2.
Xu X, Xiong S, Wang Z, Li X, Liu W. Topical administration of tranexamic acid in total hip arthroplasty: A meta-analysis of Randomized Controlled Trials. Drug Discov Ther. 2015 Jun;9(3):173-7. doi: 10.5582/ddt.2015.01018.
Ausen K, Fossmark R, Spigset O, Pleym H. Randomized clinical trial of topical tranexamic acid after reduction mammoplasty. Br J Surg. 2015 Oct;102(11):1348-53. doi: 10.1002/bjs.9878.
Bennett C, Klingenberg SL, Langholz E, Gluud LL. Tranexamic acid for upper gastrointestinal bleeding. Cochrane Database Syst Rev. 2014 Nov 21;2014(11):CD006640. doi: 10.1002/14651858.CD006640.pub3.
Other Identifiers
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5271
Identifier Type: -
Identifier Source: org_study_id
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