A clinical trial to study the effect of the drug tranexamic acid in reducing seroma after mastectomy in breast cancer patients.

Seroma Prevention after Modified Radical Mastectomy by Tranexamic Acid (SPaMTA)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058691

Enrollment

124

Registered

2023-10-16

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Tranexamic acid in perioperative period: Tranexamic acid administration in perioperative period in patients undergoing modified radical mastectomy in breast cancer. Patients in TXA grou

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of breast cancer undergoing mastectomy with axillary clearance irrespective of tumor stage. 2. Patients aged > 18 years

Exclusion criteria

Exclusion criteria: 1. Patients with history of pre-operative breast/axillary irradiation. 2. Patients with history of seizures, cerebrovascular ischemia 3. Male patients 4. History of prior ipsilateral breast or axillary surgery for any indication 5. Patients undergoing bilateral axillary dissection 6. Patients with known history of reaction to tranexamic acid. 7. Patients with any coagulation disorders

Design outcomes

Primary

Measure	Time frame
Amount of seroma formationTimepoint: Daily from first post operative days till discharge. Follow up in OPD after discharge on day 07 , 14 , 30	—

Secondary

Measure	Time frame
NoneTimepoint: Not applicable	—

Countries

India

Contacts

Public ContactRubik Ray

AIIMS Raipur

dr.rubikray@gmail.com9804659199

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026