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Recruiting NCT06270407

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

Conditions: Surgical Complication

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 3000
Sponsor: St. Olavs Hospital

Location: Vejle Sykehus Vejle

Summary

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.

Eligibility Criteria

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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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06270407). StuddyBuddy aggregates publicly available trial information.