drugset
drugset / Trial / NCT06270407

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

NCT06270407 ↗

Phase 4 Recruiting 3000 enrolled St. Olavs Hospital Bodø sykehus · collabHaraldsplass Deaconess Hospital · collabHaukeland University Hospital · collabHelse Stavanger HF · collabHelsinki University Central Hospital · collabMolde Hospital · collabOslo University Hospital · collabSmerud Medical Research International AS · collabSykehuset Asker og Baerum · collabSykehuset Innlandet HF · collabSykehuset Telemark · collabUniversity Hospital of North Norway · collab
Non-randomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2024-10-01
Primary completion
2028-12-31
Completion
2029-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tranexamic Acid Small molecule 100 mg/ml Topical

Indications

No indication recorded.