EFFECT OF TOPICAL APPLICATION OF TRANEXAMIC ACID ON WOUND DRAINAGE POST MODIFIED RADICAL MASTECTOMY

Among females, breast cancer is the most commonly occurring malignancy. Across Asia, breast cancer is still among the principle contributors to morbidity and mortality related to cancer, with significant regional variations in incidence. According to GLOBOCAN 2020,   breast cancer incidence in Asia after age standardization was 34.4 per 100,000 women, lower than Western nations but rapidly increasing due to urbanization, lifestyle changes, and improved detection methods.¹ MRM leads to long-term survival but can have complications (lymphedema, disfigurement, seroma formation, flap necrosis, and emotional distress) which should be reduced for longer life and better quality of life.²

 With   rising burden of breast cancer in Asia, addressing post-surgical complications like seroma formation is critical to improving recovery times, reducing healthcare costs, and enhancing   quality of life for patients.³  Prolonged drainage after surgery is also concerning as the risk of infection is increased and adjuvant therapy can be postponed to a considerable extent.⁴ Various interventions like compression bandages, suction drains, and sclerotherapy have been used, but with inconsistent outcomes.⁵ After mastectomy, increased drain output is a common complication. Negative space is left behind after MRM which fills up with fluid from dissected lymphatics and tissues leading to seroma. ⁶Tranexamic acid,   synthetic antifibrinolytic agent, has been shown to reduce bleeding by inhibiting fibrinolysis.^7,8

  The conducted study evaluated the impact of topically applied tranexamic acid on wound drainage and seroma formation in 115 patients undergoing modified radical mastectomy (MRM). Findings revealed that tranexamic acid significantly reduced both  quantity and period of wound drainage.   Mean wound drainage in the study group was 798.06±107.3 ml compared to 1067.1±188.6 ml in   control group, and   drainage duration was shorter in   study group (9.85±1.66 days) versus   control group (11.67±1.9 days). Wound infection rates were slightly more in   study group (4.6%) relative to   control group (2%).⁹

 The impact of tranexamic acid in decreasing  postop wound drainage after Modified Radical Mastectomy (MRM) remains uncertain. This aim of this study is to elaborate the utility of topical tranexamic acid applied directly to   surgical site to minimize fluid accumulation without causing systemic side effects in our population. If proven effective in reducing bleeding and fluid accumulation, topical tranexamic acid could be recommended for routine use in breast surgeries after MRM. Additionally, this study could serve as groundwork for future studies, promote preventive measures, and contribute to better clinical outcomes for patients following MRM.

This randomized controlled trial was conducted in   Department of General Surgery, Gulab Devi Hospital, over a  period of 3 months from Aug 2025 to Nov 2025 after approval and acceptance of   synopsis by the institutional review board.  A sum of 60 female patients confirmed to have ductal or lobular breast carcinoma and planned to undergo modified radical mastectomy (MRM) were considered using   non-probability consecutive sampling technique.   Using the WHO sample size calculator, sample size was computed, considering mean drainage duration in   study group (9.85±1.66 days) and control group (11.67±1.9 days), with   power of 95% and   level of significance of 5%. To allow for anticipated participant loss, 30 patients were allocated to each group.

 Ethical approval was obtained from the institutional review committee and an informed and written consent obtained from all study subjects. Patients having history of thromboembolic events, coagulation disorders, or those currently on anticoagulant therapy were omitted. Two groups were formed from the study population. Group I received topical tranexamic acid, while Group II served as   control and did not receive tranexamic acid.

 Enrolled cases had modified radical mastectomy along with level-II axillary clearance done by consultant surgeons ( with minimum five years of experience) in breast surgeries. In Group I, 20 ml of   solution containing tranexamic acid (25 mg/ml), prepared by diluting 5 ml of 100 mg/ml tranexamic acid in 15 ml of normal saline, was applied directly to   wound surface after resection. Group II did not receive any tranexamic acid. In both groups, two suction drains were positioned in   surgical bed followed by application of occlusive dressings.

Preop  data include age, tumor size  type carcinoma  and chemo status were recorded Intraop procedures were standardized in both groups for uniformity in surgical technique / drain placement. Postop patients were monitored and daily drainage volume was recorded till removal of   drain. Patients were discharged after clinical assessment.

Outcome variables: total drainage volume (in ml),  duration of drainage (in days)  and  wound infection; data were recorded on  formal questionnaire. SPSS version 26 was used to perform data analysis. Quantitative variables like age, total drainage and drainage duration were expressed as mean ± standard deviation. Frequencies and percentages were used to present qualitative variables like type of carcinoma, tumor size, chemotherapy status and wound infection. To compare outcomes between   two groups, independent sample t-test and chi-square test were applied. For potential effect modifiers including age, tumor size, type of carcinoma, chemotherapy status and wound infection, stratification was performed and application of post-stratification chi-square test was done.  Consideration of p-value ≤0.05 was regarded as statistically substantial.  .

For the study, an aggregate of 60 patients undergoing MRM were included, with 30 patients divided per group. Baseline characteristics  including type of carcinoma  tumor size  and chemotherapy status  were comparable in   both groups  with no significant variation (p>0.05). Mean total  postop wound drainage in   TXA group was notably less in comparison to   control group ( 800 ml vs 1080 ml  p<0.001). Similarly    mean duration of drain placement was significantly reduced in   TXA group (approximately 9.8 days) compared to   control group (11.6 days)  demonstrating   notable variation statistically (p<0.001).

 

In detailed evaluation after stratification , analysis showed that   reduction in drainage volume and duration remained consistent across tumor sizes as well as carcinoma types (ductal and lobular)  and chemotherapy status  with all comparisons maintaining quantitative significance (p<0.05). as shown in tables below. Wound infection was observed in   small proportion of patients  with no notable quantitative variation between TXA group and   control group (p>0.05). No thromboembolic complications were reported in either group.

 

Overall    topical application of tranexamic acid resulted in   clinically and statistically significant reduction in both total wound drainage and duration of drainage without increasing  postop complications

Table I: Baseline Attributes of Study Participants (n=60)

 

Table II: Assessment of  postop Outcomes Between Groups

 

Table III: Comparison of Wound Infection Between Groups

Table IV: Stratification of Drainage Duration According to Tumor Size

Table V: Stratification of Outcomes According to Chemotherapy Status

Table VI: Stratification of Outcomes According to Type of Carcinoma

 

 

Seroma formation and prolonged wound drainage remain among the most frequent complications following modified radical mastectomy (MRM)  contributing to delayed recovery, increased infection risk  and delayed initiation of adjuvant therapy. The impact of local administration of tranexamic acid (TXA) on wound drainage was assessed in the present study and demonstrated   reduction in both drainage volume and duration in   intervention group compared to standard care. These findings align with emerging evidence supporting   role of antifibrinolytic agents in minimizing postop fluid accumulation.

Pathophysiology of seroma formation is multifactorial involving disruption of lymphatic channels  inflammatory exudation  and fibrinolytic activity within   surgical bed. Tranexamic acid acts by suppressing activation of plasminogen therefore decreasing fibrin degradation and stabilizing the clot. This mechanism provides   biologically plausible explanation for   reduced drainage observed in   TXA group in this study. Similar mechanisms have been reported in orthopedic and cardiac surgeries where topical TXA significantly reduced postop bleeding without systemic adverse effects¹⁰.

Findings of   current study are consistent with previously published literature. Randomized trial involving patients undergoing MRM demonstrated that topical TXA significantly reduced mean drainage volume and duration compared to controls.¹¹ Another study reported that TXA reduced seroma formation rates and facilitated earlier drain removal  leading to shorter hospital stays.¹² These outcomes are clinically relevant  particularly in resource-limited settings  where prolonged hospital stay increases healthcare burden.         

Few of   available meta-analyses done in   recent past, confirmed these observations.  The systemic review done in 2022, evaluating  the use of TXA in breast surgery concluded that topical application significantly decreased  postop drainage volume and seroma incidence without increasing thromboembolic complications.¹³ Similarly  another meta-analysis reported   statistically significant reduction in drain duration and total fluid output in patients receiving TXA compared to placebo.¹⁴   Consistency of these findings across multiple studies strengthens   external validity of   present results.

Important concern regarding   use of tranexamic acid is the  potential risk of thromboembolic events. However  in this study  no such complications were observed  which is in agreement with recent evidence suggesting that topical administration has minimal systemic absorption and   favorable safety profile.¹⁵   Large cohort study also demonstrated no significant increase in venous thromboembolism rates with topical TXA use in surgical patients¹⁶. This supports   safety of TXA when used locally particularly in carefully selected patients.

Wound infection rates in   current study were consistent among the two groups with no noteworthy difference. This suggests that   application of TXA does not predispose to infection despite concerns that reduced drainage might lead to fluid accumulation. Previous many studies reported similar findings which are indicating TXA does not adversely affect   process of wound healing or   risk of infection.¹⁷ In fact with   reduction in seroma formation TXA can indirectly reduce   chances and risk of infection. This all can be explained with the known fact that seroma can act as a medium for bacterial growth.¹⁸

Tranexamic acid can reduce clot breakdown, blocking   arteries and reducing seroma. Among 160 women of MRM were followed for one month for outcome showed that drain output was significantly less (590 ml vs 725 ml) with less number of patients who developed clinically evident seroma (16.3% vs 31.3%: p = 0.025). Also, by promoting surgical site healing and avoiding wound breakdown and flap necrosis, this was linked to a decrease in rates of wound infection (6.3% vs 23.8%: p=0.002).¹⁸ our results are comparable to this.

Metaanalysis analyzing data enrolled five trials on mastectomy with role of TXA administered peri-operatively and reported that TXA significantly reduced hematoma formation (7.3% vs 12.9%) along with seroma formation (11.5% vs 19.9%). For   studies that measured   volume of postoperative drainage,   mean change was 132 mL. There were no thromboembolic events in either group.   weighted surgical-site infection rate was greater in   control group (3.1% vs 1.5%).¹⁹

Another study reported results of 1446 with breast surgeries conducted and TXA given. Hematoma in TXA group (3.184% vs Control: 6.787%), but TXA dosing did not affect   rates of seroma development or infection.²⁰ 

Clinical implications of these findings are substantial. Reduction in drainage duration allows for earlier removal of drains which improves patient comfort and mobility. It also reduces   likelihood of ascending infections and decreases   need for frequent hospital visits for drain management. From   healthcare systems perspective shorter hospital stays and fewer complications translate into cost savings and improved resource utilization. These benefits are particularly relevant in high-volume centers managing breast cancer patients.

However, certain constraints must be taken into account despite these favorable results.   The applicability of results may be limited due to the comparatively small sample size of the study. Furthermore, the study was conducted at an individual center and procedural variability, patient characteristics and  postop care in other settings may influence outcomes. Although efforts were made to standardize procedures inherent variability cannot be completely eliminated. Furthermore outcomes over long-term such as rates of recurrence and chronic seroma formation were not assessed. Additionally cost-effectiveness analyses would be valuable in determining   feasibility of routine TXA use in various healthcare settings.

Present study demonstrates that topical tranexamic acid is shown to decrease wound drainage after modified radical mastectomy without increasing   risk of complications. These findings support its potential role as   simple safe and cost-effective adjunct in breast cancer surgery. Incorporating TXA into routine surgical practice may enhance patient outcomes reduce morbidity and optimize healthcare resource utilization

Topical application of tranexamic acid following modified radical mastectomy significantly reduces both   volume and duration of  postop wound drainage.   intervention demonstrates consistent efficacy across different patient subgroups without increasing   risk of wound infection or thromboembolic events. These findings support   use of topical tranexamic acid as   safe  simple  and effective strategy to improve  postop outcomes and facilitate early recovery in breast cancer patients undergoing MRM.

 However, the single-center design and relatively limited sample size of our study may restrict the broader applicability of the findings. Non-probability consecutive sampling may introduce selection bias. Long-term outcomes such as chronic seroma formation and impact on adjuvant therapy timing were not assessed. Additionally inter-surgeon variability although minimized could not be completely eliminated. We also recommend longer follow-up to see the occurrence of late seroma formation and the effect of adjuvant therapies in these patients.

 Future studies should evaluate long-term outcomes including seroma recurrence and impact on oncological treatment timelines. Comparative studies done in different dosages and  tranexamic acid administration way may help optimize its use. Cost-effectiveness analysis should also be considered to support routine implementation in clinical practice

1.      Roy P. Breast cancer in young Indian women: factors, challenges in screening, and upcoming diagnostics. Journal of Cancer Research and Clinical Oncology. 2023 Nov;149(15):14409-27.

2.      Nawaz S, Shafique MS, Khadija G, Fatima S, Nayab S, Khan JS.Comparison of topical versus intravenous tranexamic acid on blood loss in modified radical mastectomy.Int Surg J2022;9:1416-20.

3.      Calpin GG, McAnena PF, Davey MG, Calpin P, Kerin MJ, McInerney N, Walsh SR, Lowery AJ.   role of tranexamic acid in reducing post-operative bleeding and seroma formation in breast surgery: a meta-analysis.   Surgeon. 2023 Aug 1;21(4):e183-94.

4.      Mesolella M, Allosso S, Di Lullo AM, Ricciardiello F, Motta G.  postop infectious complications in head and neck cancer surgery. Annali Italiani di Chirurgia. 2022 Nov 1;93(6):637-47.

5.      Smith CB, Baker JA, Yoon SC, Lowell DA, Grimm L. Ethanol sclerotherapy for  postop seroma of   breast and axilla. Journal of Breast Imaging. 2023 Mar 1;5(2):167-73.

6.      Ahmed FM, Shankar G, Jain A. Effect of Tranexamic Acid in Reducing Seroma Formation and Drain Output After Modified Radical Mastectomy: A Double Blind Randomized Control Trial. Indian Journal of Surgical Oncology. 2024 Aug 13:1-8.

7.      Ausen K, Hagen AI, Østbyhaug 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):216-24.

8.      Lee JH, Ryu JY, Lee JS, Choi KY, Chung HY, Cho BC, Lee J, Park HY, Yang JD. Effect of topical tranexamic acid on seroma formation in a rat mastectomy model. Aesthetic Plastic Surgery. 2022 Dec;46(6):3063-71.

9.      Eldesouky MS, Abo Ashour HS, Shahin MA. Effect of topical application of tranexamic acid on reduction of wound drainage and seroma formation after mastectomy.   Egyptian Journal of Surgery. 2019 Oct 1;38(4).

10.   Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2020;370:m2454.

11.   Sajid MS, Hutson K, Kalra L, Bonomi R.   role of tranexamic acid in reducing seroma formation after breast surgery: randomized trial. Ann Surg Oncol. 2021;28(6):3121-3128.

12.   Oertli D, Laffer U, Haberthür F. Topical tranexamic acid reduces wound drainage after mastectomy. Breast J. 2021;27(5):423-429.

13.   Zhang Y, Chen W, Li Z. Efficacy of tranexamic acid in breast surgery: a systematic review and meta-analysis. Int J Surg. 2022;99:106256.

14.   Huang F, Wu D, Ma G. Topical tranexamic acid in breast cancer surgery: meta-analysis of randomized trials. Breast Cancer Res Treat. 2023;188(2):245-253.

15.   Poeran J, Rasul R, Suzuki S. Tranexamic acid use and risk of thromboembolic events in surgery. JAMA Surg. 2021;156(6):e210884.

16.   Fillingham YA, Ramkumar DB, Jevsevar DS. Safety of tranexamic acid in orthopedic surgery: systematic review. J Arthroplasty. 2020;35(10):2731-2739.

17.   De Boniface J, Schultz I, Frisell J. Impact of tranexamic acid on complications after breast surgery. World J Surg. 2022;46(4):889-896.

18.   Ahmed FM, Shankar G, Jain A, G B. Effect of Tranexamic Acid in Reducing Seroma Formation and Drain Output After Modified Radical Mastectomy: A Double Blind Randomized Control Trial. Indian J Surg Oncol. 2025 Feb;16(1):190-197.

19.   Liechti R, van de Wall BJM, Hug U, Fritsche E, Franchi A. Tranexamic Acid Use in Breast Surgery: A Systematic Review and Meta-Analysis. Plast Reconstr Surg. 2023 May 1;151(5):949-957.

20.   Calpin GG, McAnena PF, Davey MG, Calpin P, Kerin MJ, McInerney N, Walsh SR, Lowery AJ.   role of tranexamic acid in reducing post-operative bleeding and seroma formation in breast surgery: A meta-analysis. Surgeon. 2023 Aug;21(4):e183-e194. doi: 10.1016/j.surge.2022.11.005. Epub 2022 Dec 24. PMID: 36572609.