SEroma Reduction pOst MAstectomy "SEROMA Study"

Breast Cancer Clinical Trial

— SEROMA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03738527
• Other study ID #: 5271
• Status: Recruiting
• Phase: Phase 4
• Start date: October 7, 2019
• Est. completion date: July 2022

Study information

• Verified date: February 2021
• Source: Hamilton Health Sciences Corporation
• Contact: Isabelle Duchesnay, M.D.
• Phone: 905-521-2100
• Email: isabelle.duchesnay[@]medportal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Hematoma
• Hematoma Postoperative
• Seroma
• Seroma Complicating A Procedure

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Juravinski Hospital - Hamilton Health Sciences	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (14)

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. — View Citation

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. — View Citation

Bennett C, Klingenberg SL, Langholz E, Gluud LL. Tranexamic acid for upper gastrointestinal bleeding. Cochrane Database Syst Rev. 2014 Nov 21;(11):CD006640. doi: 10.1002/14651858.CD006640.pub3. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013 Jul 23;(7):CD010562. doi: 10.1002/14651858.CD010562.pub2. Review. — View Citation

Ker K, Roberts I, Shakur H, Coats TJ. Antifibrinolytic drugs for acute traumatic injury. Cochrane Database Syst Rev. 2015 May 9;(5):CD004896. doi: 10.1002/14651858.CD004896.pub4. Review. — View Citation

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. — View Citation

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;(1):CD010245. doi: 10.1002/14651858.CD010245.pub2. Review. — View Citation

Pogson CJ, Adwani A, Ebbs SR. Seroma following breast cancer surgery. Eur J Surg Oncol. 2003 Nov;29(9):711-7. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Other complications rate: Hematoma rate	Rate of hematoma within 3 months following mastectomy in each arm of the study	3 months
Other	Other complications rate: Infection rate	Rate of infection within 3 months following mastectomy in each arm of the study	3 months
Other	Other complications rate: Wound dehiscence rate	Rate of wound dehiscence within 3 months following mastectomy in each arm of the study	3 months
Other	Daily output volume	Daily drain output (volume), in patients in both arms of the study	3 months
Other	Drain discontinuation	Time to drain discontinuation (number of days) in patients in both arms of the study	3 months
Other	Drain complications	Presence of drain complications (leakage, dislodgement, blockage), in patients in both arms of the study	3 months
Other	Safety outcomes: rate of thromboembolic events	Rate of Thromboembolic events within 3 weeks following mastectomy, in patients in both arms of the study	3 weeks
Other	Safety outcomes: rate of myocardial events	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	3 weeks
Other	Safety outcomes: rate of other adverse events	Rate of other adverse events within 3 weeks following mastectomy, in patients in both arms of the study	3 weeks
Primary	Recruitment rate	Number of patients recruited over the total number of eligible patients screened	About 6 months
Primary	Randomization rate	Number of patients randomized over total number recruited	About 9 months
Primary	Follow-up visit rate	Number of patients with successful follow-up visits at 3 weeks and 3 months	3 months
Primary	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	Seroma rate	Rate of seroma formation within 3 months following mastectomy in each arm of the study.	3 months
Secondary	Seroma volume	Amount of drainage (volume) in patients who did have a seroma, for patients in both arms of the study	3 months
Secondary	Seroma aspiration	Aspirated volume in patients who did have a seroma, for patients in both arms of the study	3 months
Secondary	Delay in adjuvant treatment	Time (number of weeks) of delay in adjuvant treatment due to seroma/hematoma complication, for patients in both arms of the study	3 months