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

Phase 4

Completed

• Conditions: Postoperative Hemorrhage; Seroma; Breast Neoplasms
• Interventions: Drug: saline; Drug: Tranexamic Acid

• Registration Number: NCT02627560
• Lead Sponsor: St. Olavs Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-08
• Study First Posted: 2015-12-11
• Study Start: 2016-01
• Primary Completion: 2018-10-01
• Study Completion: 2018-10-01
• Status Verified: 2018-11
• Last Update Submitted: 2020-05-08
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 202

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo control	saline	saline to be smeared on surgical wounds before closure
topical tranexamic acid	Tranexamic Acid	tranexamic acid to be smeared on surgical wounds before closure

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Department of Surgery, Aalesund Hospital; 🇳🇴 Ålesund, Norway

St Olavs University Hospital; 🇳🇴 Trondheim, Norway