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

St. Olavs Hospital

Status and phase: Completed; Phase 4

Conditions: Postoperative Hemorrhage; Seroma; Breast Neoplasms

Treatments: Drug: Tranexamic Acid; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02627560

2015/1722

2015-003160-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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®

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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202 participants in 2 patient groups, including a placebo group

topical tranexamic acid

Experimental group

Description:

tranexamic acid to be smeared on surgical wounds before closure

Treatment:

Drug: Tranexamic Acid

placebo control

Placebo Comparator group

Description:

saline to be smeared on surgical wounds before closure

Treatment:

Drug: saline