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NCT05807074 · ClinicalTrials.gov registry record · Phase 4
Impact of Topical Tranexamic Acid in Breast Reconstruction
A Phase 4 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT05807074 is a Phase 4 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 23 participants.
The verdict
NCT05807074, a Phase 4 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study Summary
Improvement in bleeding and bruising has been described by using both intravenous and topical off-label applications of Tranexamic Acid (TXA) in many surgical fields. This trial tests how well applying tranexamic acid (TXA) to the surface of the surgical site (topically) works to reduce post-operative bleeding (hematomas) and fluid collections (seromas) in women undergoing surgery to remove both breasts (bilateral mastectomy) immediately followed by surgery to rebuild the breast (reconstruction). The formation of hematomas and seromas, a common post-mastectomy complication, can interfere with breast reconstruction and increase the risk of infection and wound healing and can potentially delay cancer treatments. TXA is a synthetic molecule that pushes the body's clotting cascade toward clot formation to improve blood clotting. Applying TXA topically to the surgical site before closing the incision may prevent hematoma and seroma formation in post-mastectomy breast reconstruction patients. Participants will be recruited from patients undergoing bilateral mastectomy at University of California, San Francisco.
Interventions
- OTHER Saline
- DRUG Tranexamic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2023-04-20 |
| Est. Completion | 2024-11-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05807074
The ClinicalTrials.gov registry entry for NCT05807074 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT05807074 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05807074 about?
NCT05807074 is a clinical study titled "Impact of Topical Tranexamic Acid in Breast Reconstruction". Improvement in bleeding and bruising has been described by using both intravenous and topical off-label applications of Tranexamic Acid (TXA) in many surgical fields. This trial tests how well applying tranexamic acid (TXA) to the surface of the surgical site (topically) works to reduce post-operati...
What is the current status of trial NCT05807074?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2023-04-20. Estimated completion is 2024-11-30.
What interventions are being tested in trial NCT05807074?
The interventions under investigation include: Saline (OTHER), Tranexamic Acid (DRUG).
Who is sponsoring clinical trial NCT05807074?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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