The Effect of Topical Tranexamic Acid on Bleeding and Seroma Formation in After Undergoing Mastectomy

The Effect of Topical Administration of Tranexamic Acid on Postoperative Bleeding and Seroma Formation in Patients Undergoing Mastectomy: A Prospective Placebo-controlled Double Blinded Randomized Study

After surgical procedures, interventions to reduce postoperative bleeding are of great importance. In this study, the effect will be investigated of smearing tranexamic acid, which is designed for injection, directly onto the raw wound surface (topical application) created during surgery. Topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. The researchers have recently shown that topically applicated tranexamic acid reduces bleeding in women who had two-sided breast reduction surgery. Now it will be studied whether topically applicated tranexamic acid reduces bleeding after breast surgery for breast cancer.

After surgery for breast cancer patients may also experience problems with long lasting seroma. Therefore it will at the same time be investigated whether topical tranexamic acid reduces the development of seroma in these patients.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms; Postoperative Hemorrhage; Seroma
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: saline

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7006
    • St Olavs University Hospital
  • Ålesund, Norway
    • Department of Surgery, Aalesund Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• breast cancer
• undergoing unilateral mastectomy with or without axillary node dissection
• received adequate oral and written information about the study and signed an informed-consent form

Exclusion Criteria:

• pregnant or breastfeeding
• known thromboembolic disease or with high risk of thromboembolism, warranting extra anticoagulation in connection with the procedure
• known allergy to tranexamic acid/Cyklokapron®

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: topical tranexamic acid; tranexamic acid to be smeared on surgical wounds before closure	Drug: Tranexamic Acid; moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml
Placebo Comparator: placebo control; saline to be smeared on surgical wounds before closure	Drug: saline; moisten the surgical wound surface with 20 ml placebo (0.9% saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bleeding as defined by drain production per hour the first 24 hours	Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily drain production up to drain removal - cumulative volume		3 weeks
number of patients having surgical bleeding in need of re-operation		3 weeks
number of postoperative aspirations of clinical seroma		up to 3 months
chronic seroma (lasting more than three months)	volume of seroma aspirated	3 months

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Alesund Hospital
• Investigators: Study Director: Sverrir Olafsson, Ålesund sykehus

Publications and helpful links

General Publications

• 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.
• Ausen K, Hagen AI, Ostbyhaug HS, Olafsson S, Kvalsund BJ, Spigset O, Pleym H. Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial. BJS Open. 2020 Apr;4(2):216-224. doi: 10.1002/bjs5.50248. Epub 2019 Dec 26.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: December 8, 2015
• First Posted (Estimate): December 11, 2015

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Postoperative care; Mastectomy; Tranexamic acid; Administration, topical
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Inflammation; Postoperative Complications; Breast Diseases; Breast Neoplasms; Hemorrhage; Postoperative Hemorrhage; Seroma; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2015/1722; 2015-003160-37 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No