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.
They are to undergo a surgical procedure within the field of plastic surgery where the procedure involves use of topical TXA at the participating center.
They are over 18 years of age and capable of independently providing informed consent
They have received adequate oral and written information about the study and signed the informed-consent form
Patients with known allergy to tranexamic acid. Insufficient knowledge of national language or English.
Parallel
Tranexamic Acid 100 MG/ML
DrugIf 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
DrugIf 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.
Postoperative re-bleeding
• Comparison between wounds receiving TXA versus placebo of the incidence of postoperative re-bleeding within the first postoperative 10 days
Postoperative wound infection
• Comparison between wounds receiving TXA versus placebo of the incidence of postoperative wound infection within the first 30 days requiring any of the following: Extra outpatient follow-up, re-operation, or revision or antibiotic treatment.
Postoperative wound rupture
• Comparison between wounds receiving TXA versus placebo of the incidence of wound rupture within the first 30 days requiring any of the following: Extra outpatient follow-up, re-operation, or revision.
Postoperative thromboembolic events
• Comparison between wounds receiving TXA versus placebo of the incidence of • thromboembolic events defined as thrombophlebitis, deep venous thrombosis, pulmonary embolus, cerebral or coronary infarctions until 30 days postoperatively
Postoperative seroma
• Comparison between wounds receiving TXA versus placebo of the incidence of • seroma defined as the need for aspiration of fluids, or spontaneous evacuation of voluminous fluids, between 10 and 30 days postoperatively
Click on the lead sponsor to view all of their trials.
St. Olavs Hospital
Lead sponsor
Smerud Medical Research International AS
Collaborator
Sykehuset Asker og Baerum
Collaborator
Oslo University Hospital
Collaborator
Sykehuset Telemark
Collaborator
Sykehuset Innlandet HF
Collaborator
Molde Hospital
Collaborator
Haukeland University Hospital
Collaborator
Haraldsplass Deaconess Hospital
Collaborator
Helse Stavanger HF
Collaborator
University Hospital of North Norway
Collaborator
Bodø sykehus
Collaborator
Helsinki University Central Hospital
Collaborator
