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.
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
* The primary objective is to demonstrate that topical application of TXA is superior to placebo (saline) in preventing postoperative bleeding needing intervention within the first 10 days after surgery. Thus, the null hypothesis to be tested in relation to the primary estimand is as follows: * Null hypothesis: Re-bleeding needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events within the first 10 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as case: * Re-operation * surgical exploration or evacuation * aspiration of hematoma * blood transfusion * external extra compression due to hematoma * Alternative hypothesis: Re-bleeding as defined above occurs less often with TXA than placebo (saline)
Postoperative wound infection
* Null hypothesis: Wound infection needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case: * Extra outpatient follow-up * Re-operation or surgical revision * Antibiotic treatment. * Alternative hypothesis: Wound infection as defined above occurs more often with TXA than placebo (saline)
Postoperative wound rupture
* Null hypothesis: Wound rupture needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case: * Extra outpatient follow-up * Re-operation or surgical revision * Alternative hypothesis: Wound rupture as defined above occurs more often with TXA than placebo (saline)
Postoperative seroma
* Null hypothesis: Seroma needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case: * Active aspiration of seroma * Passive spontaneous drainage of a significant volume of seroma * Alternative hypothesis: Seroma as defined above occurs more often with TXA than placebo (saline)
Postoperative thromboembolic events
* Null hypothesis: Postoperative thromboembolic events, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case: * Deep venous thrombosis * Pulmonary embolus * Cerebral or coronary infarction * Alternative hypothesis: Thromboembolic events as defined above occurs more often with TXA than placebo (saline)
Click on the lead sponsor to view all of their trials.
St. Olavs Hospital
Lead sponsor
Smerud Medical Research International AS
Collaborator
Oslo University Hospital
Collaborator
Haraldsplass Deaconess Hospital
Collaborator
Helse Stavanger HF
Collaborator
University Hospital of North Norway
Collaborator
Helsinki University Central Hospital
Collaborator
Vejle Hospital
Collaborator
Bærum sykehus
Collaborator
Sykehuset SNR
Collaborator
Hamar sykehus
Collaborator
Tynset Sykehus
Collaborator
