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 study about?

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.

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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
St. Olavs Hospital HF	Trondheim	Norway
Helse Stavanger HF	Stavanger	Norway
Sykehuset Innlandet HF	Brumunddal	Norway
Vestre Viken HF	Drammen	Norway
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Sykehuset Oestfold HF Kalnes	Graalum	Norway
Sqbdusyxm Tjjaxuwf Hm	Skien	Norway
Hckwjdlrtfni Dpmzahhxp Shgpfpx Aq	Bergen	Norway
Haolu Bcsknq Hc	Bergen	Norway
Hbaedxid Uutsublesx Cfchtsr Hkpvvqoh	Helsinki	Finland
Hxwwu Mcoqr Oe Ryvjufe Hf	Aalesund	Norway

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	03.06.2024
Finland	Recruiting	03.06.2024
Norway	Recruiting	03.06.2024

Trial locations

Investigated drugs:

Tranexamic Acid

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.

Investigated diseases:

Post procedural complication

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 ID:

2023-510381-28-01

Protocol code:

270777

NCT ID:

NCT06270407

Trial Phase:

Therapeutic confirmatory (Phase III)

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