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The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery

RecruitingPhase 4Ages 18 Years - anyAllSt. Olavs Hospital
NCT06270407 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Study objective: This is a study to investigate whether applying the drug tranexamic acid (TXA) onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention, wound complications such as infection, wound rupture or seroma, or if it may increase the risk of blood clots. Eligible patients: Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery. Study intervention: Participants will receive a single local application of study drug onto their wound surfaces at the end of surgery. Study drug will be identical looking ampoules which contain either TXA or placebo (saline). Neither participants nor study personnel will know the contents of the ampoules.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients are eligible to be included in the study only if all of the following criteria apply: 1. They are to undergo a surgical procedure within the field of plastic surgery where the procedure involves use of topical TXA at the participating center. 2. They are over 18 years of age and capable of independently providing informed consent 3. They have received adequate oral and written information about the study and signed the informed-consent form Exclusion Criteria: * Patients with known allergy to tranexamic acid.
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What it tests

  • Tranexamic Acid 100 MG/ML
  • 0.9%sodium chloride
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Where

11 sites
Vejle Sykehus
Vejle, Denmark
Helsinki University Hospital HUS
Helsinki, Finland
Haraldsplass Diakonale Sykehus
Bergen, Norway
Bærum Sykehus
Gjettum, Norway
Sykehuset Innlandet Hamar
Hamar, Norway
Sykehuset Nordmøre og Romsdal
Hjelset, Norway
Oslo Universitetssykehus Rikshospitalet
Oslo, Norway
Stavanger Universitetssykehus SUS
Stavanger, Norway

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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