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

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.

Conditions

• Surgical Complication

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.

Sponsors & Collaborators

• Smerud Medical Research International AS

  collaborator OTHER

• Sykehuset Asker og Baerum

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Sykehuset Telemark

  collaborator OTHER_GOV

• Sykehuset Innlandet HF

  collaborator OTHER

• Molde Hospital

  collaborator OTHER

• Haukeland University Hospital

  collaborator OTHER

• Haraldsplass Deaconess Hospital

  collaborator OTHER

• Helse Stavanger HF

  collaborator OTHER_GOV

• University Hospital of North Norway

  collaborator OTHER

• Bodø sykehus

  collaborator UNKNOWN

• Helsinki University Central Hospital

  collaborator OTHER

• St. Olavs Hospital

  lead OTHER

Principal Investigators

• Kjersti Ausen, MD PhD · St Olav's University Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2028-12-31

Completion

2029-12-31

Countries

• Norway

Study Locations