Actively Recruiting
The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery
Led by St. Olavs Hospital · Updated on 2024-12-04
3000
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
Sponsors
S
St. Olavs Hospital
Lead Sponsor
S
Smerud Medical Research International AS
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing a plastic surgery procedure involving topical tranexamic acid at a participating center
- Age 18 years or older
- Able to provide informed consent independently
- Received adequate oral and written information about the study and signed the consent form
You will not qualify if you...
- Known allergy to tranexamic acid
- Insufficient knowledge of national language or English
AI-Screening
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Trial Site Locations
Total: 1 location
1
St Olav's University Hospital
Trondheim, Norway, 7006
Actively Recruiting
Research Team
K
Kjersti Ausen, MD PhD
CONTACT
O
Olav Spigset, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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