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RECRUITING
NCT06270407
PHASE4

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

Sponsor: St. Olavs Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

3000

Start Date

2024-10-01

Completion Date

2029-12-31

Last Updated

2024-12-04

Healthy Volunteers

No

Interventions

DRUG

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

DRUG

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.

Locations (1)

St Olav's University Hospital

Trondheim, Norway