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Completed

NCT Number: NCT02627560

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

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.

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Key information

Conditions

Postoperative Hemorrhage Breast Diseases Breast Neoplasms Hemorrhage Inflammation Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Seroma Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

St Olavs University Hospital, Trondheim, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • breast cancer
  • undergoing unilateral mastectomy with or without axillary node dissection
  • received adequate oral and written information about the study and signed an informed-consent form

Exclusion criteria

  • pregnant or breastfeeding
  • known thromboembolic disease or with high risk of thromboembolism, warranting extra anticoagulation in connection with the procedure
  • known allergy to tranexamic acid/Cyklokapron®

Treatment and study plan

Tranexamic Acid

Drug

moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml

Saline

Drug

moisten the surgical wound surface with 20 ml placebo (0.9% saline)

Primary outcomes

  1. 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

Secondary outcomes

  1. Daily drain production up to drain removal - cumulative volume

    Time frame: 3 weeks

  2. number of patients having surgical bleeding in need of re-operation

    Time frame: 3 weeks

  3. number of postoperative aspirations of clinical seroma

    Time frame: up to 3 months

  4. chronic seroma (lasting more than three months)

    Time frame: 3 months

    volume of seroma aspirated

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Alesund Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2015
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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