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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Effect of Topical Administration of Tranexamic Acid on Postoperative Bleeding and Seroma Formation in Patients Undergoing Mastectomy: A Prospective Placebo-controlled

Brief 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.


Detailed Summary:
Sponsor: St. Olavs Hospital

Current Primary Outcome: bleeding as defined by drain production per hour the first 24 hours [ Time Frame: 24 hours postoperatively ]

Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Daily drain production up to drain removal - cumulative volume [ Time Frame: 3 weeks ]
  • number of patients having surgical bleeding in need of re-operation [ Time Frame: 3 weeks ]
  • number of postoperative aspirations of clinical seroma [ Time Frame: up to 3 months ]
  • chronic seroma (lasting more than three months) [ Time Frame: 3 months ]
    volume of seroma aspirated


Original Secondary Outcome: Same as current

Information By: St. Olavs Hospital

Dates:
Date Received: December 2, 2015
Date Started: January 2016
Date Completion: January 2020
Last Updated: March 6, 2017
Last Verified: March 2017