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NCT Number: NCT07434453

"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.

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Key information

Conditions

Breast Cancer Females

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

king Edward medical university/mayo hospital lahore

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all females.
  • Age more than 18 Years

Exclusion criteria

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

Treatment and study plan

Tranexamic Acid (Topical Application in Mastectomy Wound)

Drug

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

flap fixation

Procedure

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.

Primary outcomes

  1. Total Postoperative Drain Output

    Time frame: Measured from the day of surgery until drain removal days after surgery.

    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.

Secondary outcomes

  1. Incidence of Surgical Site Infection

    Time frame: Within 30 days postoperatively

    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.

  2. Incidence of Postoperative Seroma Formation

    Time frame: Within 30 days after surgery

    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.

Sponsors and collaborators

Lead sponsor

Noor ul Ain

Other

Collaborators

  • King Edward Medical University

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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