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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627560
• Other study ID #: 2015/1722
• Secondary ID: 2015-003160-37
• Status: Completed
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: October 1, 2018

Study information

• Verified date: November 2018
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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®

Related Conditions & MeSH terms

• Breast Neoplasms
• Hemorrhage
• Postoperative Hemorrhage
• Seroma

Intervention

Drug:
• Tranexamic Acid
moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml
• saline
moisten the surgical wound surface with 20 ml placebo (0.9% saline)

Locations

Country	Name	City	State
Norway	Department of Surgery, Aalesund Hospital	Ålesund
Norway	St Olavs University Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Alesund Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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

Ausen K, Hagen AI, Østbyhaug 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. Epu — View Citation

Outcome

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

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