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

NCT07434453 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-02-25

No results posted yet for this study

Summary

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.

Conditions

  • Breast Cancer Females

Interventions

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

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.

Sponsors & Collaborators

  • King Edward Medical University

    collaborator OTHER

  • Noor ul Ain

    lead OTHER

Principal Investigators

  • noor-ul-ain mujahid, FCPS(general surgery) · King Edward Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-04
Primary Completion
2024-08-30
Completion
2024-08-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07434453 on ClinicalTrials.gov