NCT02627560

The Effect of Topical Tranexamic Acid on Bleeding and Seroma Formation in After Undergoing Mastectomy

The Effect of Topical Administration of Tranexamic Acid on Postoperative Bleeding and Seroma Formation in Patients Undergoing Mastectomy: A Prospective Placebo-controlled Double Blinded Randomized Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

After surgical procedures, interventions to reduce postoperative bleeding are of great importance. In this study, the effect will be investigated of smearing tranexamic acid, which is designed for injection, directly onto the raw wound surface (topical application) created during surgery. Topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. The researchers have recently shown that topically applicated tranexamic acid reduces bleeding in women who had two-sided breast reduction surgery. Now it will be studied whether topically applicated tranexamic acid reduces bleeding after breast surgery for breast cancer. After surgery for breast cancer patients may also experience problems with long lasting seroma. Therefore it will at the same time be investigated whether topical tranexamic acid reduces the development of seroma in these patients.

Conditions

• Postoperative Hemorrhage
• Breast Neoplasms
• Seroma

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml
DRUG	saline	moisten the surgical wound surface with 20 ml placebo (0.9% saline)

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2015-12-11
• Last updated: 2020-05-12

Locations

2 sites across 1 country: Norway