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

Condition(s) studied

Investigational drug(s) / intervention(s)

Tranexamic 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

0.9%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.

Study 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

Primary outcome measure(s)

• Postoperative re-bleeding — 10 days
  * The primary objective is to demonstrate that topical application of TXA is superior to placebo (saline) in preventing postoperative bleeding needing intervention within the first 10 days after surgery. Thus, the null hypothesis to be tested in relation to the primary estimand is as follows: * Null hypothesis: Re-bleeding needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events within the first 10 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as case: * Re-operation * surgical exploration or evacuation * aspiration of hematoma * blood transfusion * external extra compression due to hematoma * Alternative hypothesis: Re-bleeding as defined above occurs less often with TXA than placebo (saline)

Trial sites (11)

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