Clinical trial · Interventional
"Topical Tranexamic Acid With Flap Fixation: A Novel Approach to Minimize Post-operative Drainage and Surgical Site Infection in Patients Undergoing Modified Radical Mastectomy"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Females | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| flap fixation | Procedure | — | UNRESOLVED |
| Tranexamic Acid (Topical Application in Mastectomy Wound) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A: Received topical tranexamic acid (TXA) along with flap fixation.
- description
- 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.
- interventionNames
- Drug: Tranexamic Acid (Topical Application in Mastectomy Wound)
- type
- ACTIVE_COMPARATOR
- label
- Arm 2: Active Comparator - Flap Fixation Only
- description
- 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.
- interventionNames
- Procedure: flap fixation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available