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Study of Tranexamic Acid Applied to Surgical Wounds to Prevent Bleeding Complications After Plastic Surgery in Adult Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines the effectiveness of tranexamic acid in reducing complications after plastic surgery. The research focuses on patients who undergo plastic surgical procedures where this medication would normally be used to reduce bleeding after the operation. The study will compare tranexamic acid applied directly to surgical wounds with placebo to determine its effects on post-surgical bleeding and other complications.

During the study, patients will receive either tranexamic acid solution or placebo applied to their surgical wound surfaces. The medication will be given as a single dose during the surgery. The maximum dose used will be 500 mg of tranexamic acid or an equivalent amount of sodium chloride solution as placebo. Both solutions will be applied directly to the wound surface.

The main purpose is to determine if applying tranexamic acid to surgical wounds can reduce the need for additional procedures due to bleeding within 10 days after surgery. The study will also monitor other post-surgical complications such as wound infections, wound rupture, fluid collection (called seroma), and blood clots (called thromboembolic events) for up to 30 days after the surgery.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial surgery and medication application

    During the plastic surgery procedure, you will receive either tranexamic acid or a placebo solution (salt water) applied directly to the surgical wound surface.

    The medication application is performed as a single dose during the surgery.

    Neither you nor your doctor will know which solution is being used in your case.

  2. Step 2

    First 10 days after surgery

    Your surgical site will be monitored for any signs of re-bleeding.

    If needed, medical staff may perform additional procedures such as: surgical exploration, fluid removal, blood transfusion, or extra compression.

    You should report any unusual bleeding or complications to the medical team.

  3. Step 3

    Days 10-30 after surgery

    Your surgical site will continue to be monitored for:

    - Wound infection that might require additional clinic visits, surgery, or antibiotics

    - Wound opening that might require additional clinic visits or surgery

    - Fluid buildup (seroma) that might need drainage

    - Blood clots in legs, lungs, brain, or heart

    Any other health issues related to the surgery will be documented during this period.

  4. Step 4

    Final evaluation

    At the end of the 30-day period, your participation in the study will be complete.

    All complications or events that occurred during the study period will be recorded and evaluated.

Who can join the trial?

6 criteria

  • You must be scheduled to have a plastic surgery procedure where TXA (tranexamic acid - a medication that helps reduce bleeding) would normally be used during the operation
  • You must be at least 18 years old
  • You must be able to make decisions about your medical care independently
  • You must be able to understand the study information provided to you both verbally and in writing
  • You must sign a consent form showing you agree to participate in the study after receiving and understanding all the information
  • Both men and women can participate in this study

Who cannot join the trial?

12 criteria

  • Known allergic reaction to tranexamic acid (TXA) or any of its components
  • Current or recent history of blood clotting disorders (conditions that make blood more likely to form clots)
  • Active bleeding disorders (conditions that prevent normal blood clotting)
  • Pregnancy or breastfeeding
  • Current use of blood-thinning medications (anticoagulants)
  • Severe kidney dysfunction (problems with kidney function)
  • History of thromboembolism (blood clots that can travel through blood vessels)
  • Uncontrolled high blood pressure (hypertension)
  • Active infection in the surgical area
  • Participation in another clinical trial within the past 30 days
  • Unable to provide informed consent
  • Age under 18 years
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Investigated drugs

Tranexamic acid (TXA) This medication is applied directly to surgical wounds during plastic surgery procedures. It helps control bleeding by preventing blood clots from breaking down too quickly. The medication is used as a topical treatment, which means it is placed directly on the wound surface during surgery. It's commonly used to reduce blood loss and prevent the need for additional procedures due to post-surgery bleeding. Placebo A substance that looks identical to the active medication but contains no active ingredients. It's used as a comparison to determine if the active medication is effective. Note: Both treatments in this trial are applied topically (directly on the surgical wound surface) during plastic surgery procedures.

What is already known about the treatment

Tranexamic acid (TXA) – A medication administered topically (applied directly to the surface) to surgical wounds during plastic surgery procedures to control bleeding and reduce post-surgical complications. This antifibrinolytic agent works by blocking the breakdown of blood clots at the molecular level, which helps maintain clot stability and reduces excessive bleeding. TXA is well-established in medical literature and currently approved for various surgical applications, with substantial evidence supporting its effectiveness in reducing blood loss during and after surgery. The medication belongs to the class of antifibrinolytic agents and has become a standard treatment option in plastic surgery, particularly for preventing post-operative bleeding complications and reducing the need for additional surgical interventions.

Investigated diseases

  • Post-surgical Bleeding

    A condition where excessive bleeding occurs after a surgical procedure. It typically develops within the first few days following surgery and may result in the formation of hematomas. Blood accumulates beneath the skin or within tissue spaces, causing swelling and discomfort.

  • Surgical Site Infection

    An infection that occurs at or near the surgical incision site within 30 days after the procedure. The condition typically presents with redness, swelling, warmth, and discharge from the wound area.

  • Wound Dehiscence

    A surgical complication where the wound edges separate or split open after the initial closure. This condition can develop within the first few weeks after surgery, compromising the healing process.

  • Thromboembolism

    A condition where blood clots form and travel through blood vessels, potentially blocking circulation. It can manifest as deep vein thrombosis in legs, pulmonary embolism in lungs, or clots affecting brain or heart vessels.

  • Seroma

    A collection of clear fluid that builds up under the skin surface following surgery. It typically develops between 10 and 30 days post-surgery, appearing as a soft swelling filled with serous fluid beneath the surgical site.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510381-28-01Protocol code270777Estimated enrolment3 500 patientsSponsorSt. Olavs Hospital HF

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