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

NCT02627560 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2020-05-12

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Alesund Hospital

    collaborator OTHER

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Petter Aadahl, MD PhD · St. Olavs Hospital

  • Sverrir Olafsson · Ålesund Sykehus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-10-01
Completion
2018-10-01

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02627560 on ClinicalTrials.gov