Clinical trial · Interventional
SEroma Reduction pOst MAstectomy "SEROMA Study"
Pilot RCT: Use of Tranexamic Acid (TXA) in Post Mastectomy Patients for Seroma and Hematoma Prevention
- 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)
This is a pilot study to evaluate the feasibility of conducting a larger trial to determine if the use of intraoperative topical tranexamic acid (TXA) decreases the rate of post-operative hematomas and seromas in breast cancer patients after their mastectomy. In other words, the investigators want to determine if applying TXA inside the surgical wound before it is closed helps reduce blood or serous fluid accumulation at the operative site. Dependent on the results of this study, a further larger trial may or may not take place. Post-operative seromas and hematomas are common complications of mastectomy surgery not only leading to infection, discomfort, wound dehiscence or emergency room visits; they also delay in some instances post-operative adjuvant radiotherapy. Establishing whether or not topical TXA is an effective strategy to decrease those complications can potentially impact positively the breast cancer treatment. To achieve this aim, this randomized pilot study will first determine whether a larger multicenter study if feasible. This study will replicate a formal randomized trial at a smaller scale in a single center in order to assess the recruitment and randomization process, as well as provide preliminary results for our research question.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hematoma Postoperative | — | UNRESOLVED | — |
| Seroma Complicating A Procedure | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Normal Saline Flush, 0.9%, 20mL topical | Drug | — | UNRESOLVED |
| Tranexamic Acid 100mg/mL, 20mL topical | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TXA arm
- interventionNames
- Drug: Tranexamic Acid 100mg/mL, 20mL topical
- type
- PLACEBO_COMPARATOR
- label
- Placebo arm
- interventionNames
- Drug: Normal Saline Flush, 0.9%, 20mL topical
Primary outcomes (4)
- measure
- Recruitment rate
- timeFrame
- About 6 months
- description
- Number of patients recruited over the total number of eligible patients screened
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer diagnosis * Age 18-80 * Fluent in English * Female undergoing mastectomy with or without axillary intervention Exclusion Criteria: * Immediate reconstruction * Pre-surgical radiation * Known allergy to TXA * Known thromboembolic disease * High-risk of thromboembolism and/or receiving anticoagulants * History of myocardial infarction (MI), transient ischemic attack or stroke within the last year * History of subarachnoid hemorrhage * Premenopausal women with irregular menstrual bleeding of unknown cause * Acquired disturbances of colour vision * Hematuria with renal cause * History of seizure disorder * Pregnant or breastfeeding
References
Publications (14)
- BACKGROUNDPorter KA, O'Connor S, Rimm E, Lopez M. Electrocautery as a factor in seroma formation following mastectomy. Am J Surg. 1998 Jul;176(1):8-11. doi: 10.1016/s0002-9610(98)00093-2. PMID 9683123
- BACKGROUNDPogson CJ, Adwani A, Ebbs SR. Seroma following breast cancer surgery. Eur J Surg Oncol. 2003 Nov;29(9):711-7. doi: 10.1016/s0748-7983(03)00096-9. PMID 14602488
- BACKGROUNDvan Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17. PMID 21849243
- BACKGROUNDCoveney EC, O'Dwyer PJ, Geraghty JG, O'Higgins NJ. Effect of closing dead space on seroma formation after mastectomy--a prospective randomized clinical trial. Eur J Surg Oncol. 1993 Apr;19(2):143-6. PMID 8491318
- BACKGROUNDBaker E, Piper J. Drainless mastectomy: Is it safe and effective? Surgeon. 2017 Oct;15(5):267-271. doi: 10.1016/j.surge.2015.12.007. Epub 2016 Feb 19. PMID 26907221
- BACKGROUNDHe XD, Guo ZH, Tian JH, Yang KH, Xie XD. Whether drainage should be used after surgery for breast cancer? A systematic review of randomized controlled trials. Med Oncol. 2011 Dec;28 Suppl 1:S22-30. doi: 10.1007/s12032-010-9673-2. Epub 2010 Sep 9. PMID 20827578
- BACKGROUNDKer K, Roberts I, Shakur H, Coats TJ. Antifibrinolytic drugs for acute traumatic injury. Cochrane Database Syst Rev. 2015 May 9;2015(5):CD004896. doi: 10.1002/14651858.CD004896.pub4. PMID 25956410
- BACKGROUNDGupta K, Rastogi B, Krishan A, Gupta A, Singh VP, Agarwal S. The prophylactic role of tranexamic acid to reduce blood loss during radical surgery: A prospective study. Anesth Essays Res. 2012 Jan-Jun;6(1):70-3. doi: 10.4103/0259-1162.103378.