CompletedNot Applicable

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

Pakistan62 participantsStarted 2023-08-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total Postoperative Drain Output

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

Trial details

NCT IDNCT07434453

SponsorNoor ul Ain

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-30

View on ClinicalTrials.gov More Breast Cancer Females trials