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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Postoperative Hemorrhage, Breast Neoplasms, Seroma

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: saline


Participation Criteria
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Eligibility Criteria
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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®

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Administration, topical, Tranexamic acid, Postoperative care, Mastectomy