Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Postoperative Hemorrhage | — | UNRESOLVED | — |
| Seroma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| saline | Drug | — | UNRESOLVED |
| Tranexamic Acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- topical tranexamic acid
- description
- tranexamic acid to be smeared on surgical wounds before closure
- interventionNames
- Drug: Tranexamic Acid
- type
- PLACEBO_COMPARATOR
- label
- placebo control
- description
- saline to be smeared on surgical wounds before closure
- interventionNames
- Drug: saline
Primary outcomes (1)
- measure
- bleeding as defined by drain production per hour the first 24 hours
- timeFrame
- 24 hours postoperatively
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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®
References
Publications (2)
- BACKGROUNDAusen 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. PMID 26349843
- RESULTAusen 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. PMID 32207575