"Topical Tranexamic Acid With Flap Fixation: A Novel Approach to Minimize Post-operative Drainage and Surgical Site Infection in Patients Undergoing Modified Radical Mastectomy"

Seroma (a collection of fluid under the skin) is a common problem after breast cancer surgery, especially after modified radical mastectomy (MRM), where lymph nodes from the armpit are also removed. This can happen because surgery may damage small blood and lymph vessels. Doctors use different methods to reduce this fluid buildup, such as special glues, drains, and stitching techniques, but results are not always the same.

Tranexamic acid (TXA) is an affordable medicine that can help reduce bleeding, bruising, and fluid collection after surgery. A study at Mayo Hospital (2023-2024) looked at whether applying TXA directly to the surgical wound, along with a stitching method called flap fixation, could improve healing after breast cancer surgery.

In this study, 62 patients were divided into two groups. One group received TXA in the wound plus flap fixation, while the other group had flap fixation only. Researchers compared wound infection rates and the amount of fluid collected after surgery.

The results showed that using TXA with flap fixation significantly reduced fluid collection (seroma) and wound infection. This method is safe, simple, and cost-effective, and may help improve recovery for patients undergoing breast cancer surgery.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Females
• Intervention / Treatment: Drug: Tranexamic Acid (Topical Application in Mastectomy Wound); Procedure: flap fixation

Detailed Description

Seroma is invariably associated with breast cancer surgery and is a recurring, problematic issue that has affected large number of patients. MRM in patients having locally advanced breast cancer has raised serious questions about the methods of prevention and management of subsequent seroma as axillary dissection is a strong risk factor for seroma formation, most likely damaging blood and lymphatic vessels. Various methods like topical fibrin sealants, suction drainage and quilting have been used to reduce its incidence with variable outcomes. Topical tranexamic acid (TXA) was demonstrated as a unique and inexpensive pharmacologic agent capable of decreasing blood loss, hematoma, seroma, and bruising among various general surgical and reconstructive procedures.

A study was conducted to assess the impact of applying tranexamic acid topically in combination with flap fixation on wound outcomes in patients undergoing MRM for breast cancer, focusing on the incidence of surgical site infections and the volume of postoperative drainage on surgical floor, of Mayo Hospital from 2023 to 2024.

After taking approval from ethical committee a total of 62 patients were selected as per inclusion criteria. The patients were randomized into two groups i.e. Group A patients underwent topical application of tranexamic acid along with flap fixation in mastectomy wound. While in group B patients, mastectomy wound was closed without topical application of tranexamic acid with flap fixation.

Data was entered in SPSS 26 version. Comparative analysis of two groups, Group A (with topical tranexamic acid application along with Flap Fixation) and Group B (without topical tranexamic acid application along with Flap Fixation) was done by applying chi-square test for wound infection and independent t-test for drain volume. P value <0.05 will be considered important.

Topical application of tranexamic acid, along with flap fixation has been found to decrease seroma formation and surgical site infection to a significant extent. Not only is this technique cost-effective but it is also easily applicable in patients with breast cancer who are scheduled to undergo MRM.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • king Edward medical university/mayo hospital lahore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. all females.
2. Age more than 18 Years

Exclusion Criteria:

1. high risk of thromboembolism requiring anti-coagulant in perioperative period
2. known allergy to Tranexamic acid documented in history
3. patients requiring delayed wound closure after MRM
4. wound edge necrosis documented on examination postoperatively
5. preoperative involvement of muscle and bone and less than R0 resection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A: Received topical tranexamic acid (TXA) along with flap fixation.; Arm 1 - Experimental Arm: Participants undergoing modified radical mastectomy (MRM) received topical tranexamic acid (TXA) applied to the surgical wound along with flap fixation at the time of wound closure to reduce postoperative seroma formation, drainage volume, and surgical site infection.	Drug: Tranexamic Acid (Topical Application in Mastectomy Wound); Participants undergoing modified radical mastectomy (MRM) for breast cancer were randomized into two groups. In the experimental group, tranexamic acid (TXA) was applied topically to the mastectomy wound at the time of surgical closure, in addition to flap fixation. In the control group, wound closure was performed with flap fixation alone, without topical tranexamic acid. Both groups received standard perioperative surgical care according to institutional practice. Postoperative outcomes assessed included seroma formation, total drain output, and surgical site infection during the follow-up period
Active Comparator: Arm 2: Active Comparator - Flap Fixation Only; Participants undergoing modified radical mastectomy (MRM) receive standard wound closure with flap fixation without topical tranexamic acid. Postoperative outcomes assessed include seroma formation, total drain output, and surgical site infection up to the 30th postoperative day.	Procedure: flap fixation; Participants undergoing modified radical mastectomy (MRM) receive standard wound closure with flap fixation without topical tranexamic acid. Postoperative outcomes assessed include seroma formation, total drain output, and surgical site infection up to the 30th postoperative day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Postoperative Drain Output	Total volume of fluid collected from the surgical drain following modified radical mastectomy. Drain output was measured in millilitres (mL) using calibrated closed suction drainage containers placed at the operative site. The cumulative volume recorded was documented for each participant.	Measured from the day of surgery until drain removal days after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Surgical Site Infection	Occurrence of surgical site infection within 30 days after surgery. Surgical site infection was diagnosed based on clinical criteria including purulent discharge from the wound, erythema, local warmth, swelling, pain, or wound dehiscence requiring antibiotic therapy. it is measured in percentage.	Within 30 days postoperatively
Incidence of Postoperative Seroma Formation	Postoperative seroma formation was defined as the accumulation of clinically detectable serous fluid at the mastectomy or axillary surgical site after drain removal. Diagnosis was made based on clinical examination showing localized swelling or fluctuation at the operative site, confirmed by aspiration of serous fluid when required. Cases requiring needle aspiration were recorded as seroma. The incidence was calculated as the proportion of participants who developed seroma among the total number of participants in each group.	Within 30 days after surgery

Collaborators and Investigators

• Sponsor: Noor ul Ain
• Collaborators: King Edward Medical University
• Investigators: Principal Investigator: noor-ul-ain mujahid, FCPS(general surgery), King Edward Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2023
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid
• Other Study ID Numbers: 705/RC/KEMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data collected during this study will not be made publicly available. However, summary results may be shared through scientific publications or presentations while maintaining participant confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No