RecruitingPhase 4NCT06270407

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

The Effect of Topical Tranexamic Acid on Postoperative Complications in Soft Tissue Plastic Surgery - A Multicenter Randomized Controlled Trial

Sponsor

St. Olavs Hospital

Enrollment

3,000 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Surgical Complication

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria1

Patients with known allergy to tranexamic acid. Insufficient knowledge of national language or English.

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Interventions

DRUGTranexamic Acid 100 MG/ML

If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using tranexamic acid

DRUG0.9%sodium chloride

If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using Tranexamic Acid.