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

Any serious postoperative complication needing intervention, specifically re-bleeding, wound infection, wound rupture, or the occurrence of blood clots for the first 30 days after surgery will be registered through the following interventions:

• Screening of patient medical records
• Distribution of an electronic self-report form (eForsk®) to participating patients at postoperative day 30
• Follow-up phone call to verify data after day 30.

The study is terminated after the final phone call. All study data will be registered in an electronic, pseudonymous web-based registration form (eCRF/Viedoc®).

Number of participants: To assess the effect of TXA on the defined surgical complications compared to placebo, 1500 patients are needed in each group.

Data monitoring committee:

A data monitoring committee consisting of a group of independent scientists will be appointed for this study to monitor the safety and scientific integrity of this human research intervention.

Inclusion criteria

• Patients are eligible to be included in the study only if all of the following criteria apply:

• 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.
• They are over 18 years of age and capable of independently providing informed consent
• 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. Insufficient knowledge of national language or English.