SEroma Reduction pOst MAstectomy "SEROMA Study"

NCT03738527 | Unknown Phase 4 DMC

• 1 other identifier: 5271
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  Number of patients recruited over the total number of eligible patients screened

  About 6 months

• Randomization rate

  Number of patients randomized over total number recruited

  About 9 months

• Follow-up visit rate

  Number of patients with successful follow-up visits at 3 weeks and 3 months

  3 months

• Ability to adhere to protocol

  Number of patients randomized to TXA who received TXA vs number of patients randomized to placebo who received the placebo

  About 12 months

Secondary Outcomes (4)

• Seroma rate

  3 months

• Seroma volume

  3 months

• Seroma aspiration

  3 months

• Delay in adjuvant treatment

  3 months

Other Outcomes (9)

• Other complications rate: Hematoma rate

  3 months

• Other complications rate: Infection rate

  3 months

• Other complications rate: Wound dehiscence rate

  3 months

Study Arms (2)

TXA arm

EXPERIMENTAL

Drug: Tranexamic Acid 100mg/mL, 20mL topical

Placebo arm

PLACEBO COMPARATOR

Drug: Normal Saline Flush, 0.9%, 20mL topical

Interventions

Tranexamic Acid 100mg/mL, 20mL topical DRUG

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

TXA arm

Normal Saline Flush, 0.9%, 20mL topical DRUG

Drug: Normal Saline 20 mL 0.9% NaCl (normal saline) applied topically to the mastectomy cavity for 5 minutes before wound closure

Placebo arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer diagnosis
• Age 18-80
• Fluent in English
• Female undergoing mastectomy with or without axillary intervention

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (2)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Juravinski Hospital - Hamilton Health Sciences

Hamilton, Ontario, L8V 1C3, Canada

RECRUITING

Related Publications (14)

• 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.

  PMID: 9683123 BACKGROUND

• 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.

  PMID: 14602488 BACKGROUND

• 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.

  PMID: 21849243 BACKGROUND

• 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.

  PMID: 8491318 BACKGROUND

• 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.

  PMID: 26907221 BACKGROUND

• 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.

  PMID: 20827578 BACKGROUND

• 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.

  PMID: 25956410 BACKGROUND

• 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.

  PMID: 25885506 BACKGROUND

• 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.

  PMID: 23440847 BACKGROUND

• 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.

  PMID: 8044602 BACKGROUND

• 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.

  PMID: 23881695 BACKGROUND

• 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.

  PMID: 26193938 BACKGROUND

• 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.

  PMID: 26349843 BACKGROUND

• 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.

  PMID: 25414987 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Seroma; Hematoma

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Nicole Hodgson, MD, MSc, FRCSC

  Hamilton Health Sciences, McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Duchesnay, M.D.

CONTACT

905-521-2100; isabelle.duchesnay@medportal.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: November 13, 2018
• Study Start: October 7, 2019
• Primary Completion: January 1, 2022
• Study Completion: July 1, 2022
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)