"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 | Completed

• 1 other identifier: 705/RC/KEMU
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of Surgical Site Infection

  Within 30 days postoperatively

• Incidence of Postoperative Seroma Formation

  Within 30 days after surgery

Study Arms (2)

Group A: Received topical tranexamic acid (TXA) along with flap fixation.

EXPERIMENTAL

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)

Arm 2: Active Comparator - Flap Fixation Only

ACTIVE COMPARATOR

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

Interventions

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

Group A: Received topical tranexamic acid (TXA) along with flap fixation.

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.

Arm 2: Active Comparator - Flap Fixation Only

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study includes patients with breast cancer undergoing modified radical mastectomy (MRM). As the target population in this study is female breast cancer patients, only females are eligible for participation.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all females.
• Age more than 18 Years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Noor ul Ain: lead
• King Edward Medical University: collaborator

Study Sites (1)

king Edward medical university/mayo hospital lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• noor-ul-ain mujahid, FCPS(general surgery)

  King Edward Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor of surgery

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 25, 2026
• Study Start: August 4, 2023
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: February 25, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)