The Effect of Topical Tranexamic Acid on Postoperative Complications in Soft Tissue Plastic Surgery. A Multicenter Randomized Controlled Trial
- Conditions
- Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery.
- Interventions
- Drug: Tranexamic Acid 100 MG/ML
- Registration Number
- 2023-510381-28-01
- Lead Sponsor
- St. Olavs Hospital HF
- Brief Summary
The main objective is to investigate whether topical use of TXA onto a surgical wound surface affects the incidence of postoperative re-bleeding needing intervention within 10 days after surgery.
- Detailed Description
Any serious postoperative complication needing intervention, specifically re-bleeding, wound infection, wound rupture, or the occurrence of blood clots for the first 30 days after surgery will be registered through the following interventions:
* Screening of patient medical records
* Distribution of an electronic self-report form (eForsk®) to participating patients at postoperative day 30
* Follow-up phone call to verify data after day 30.
The study is terminated after the final phone call. All study data will be registered in an electronic, pseudonymous web-based registration form (eCRF/Viedoc®).
Number of participants: To assess the effect of TXA on the defined surgical complications compared to placebo, 1500 patients are needed in each group.
Data monitoring committee:
A data monitoring committee consisting of a group of independent scientists will be appointed for this study to monitor the safety and scientific integrity of this human research intervention.
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 3200
Patients are to undergo a surgical procedure within the field of plastic surgery where the procedure involves use of topical TXA at the participating center.
Patients are over 18 years of age and capable of independently providing informed consent.
Patients have received adequate oral and written information about the study and signed the informed-consent form .
Patients with known allergy to tranexamic acid.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tranexamic acid arm Tranexamic Acid 100 MG/ML Anonymous ampoule containing 5 ml of 100 mg/ml Tranexamic Acid. 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. Placebo arm 0.9%sodium chloride Anonymous ampoule containing 5 ml of 0.9% NaCl. 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.
- Primary Outcome Measures
Name Time Method Given one or several of the following occurrences, re-bleeding will be defined as “yes”: Re-operation, surgical exploration or evacuation, aspiration, blood transfusion or external extra compression due to hematoma within the first postoperative 10 days Given one or several of the following occurrences, re-bleeding will be defined as “yes”: Re-operation, surgical exploration or evacuation, aspiration, blood transfusion or external extra compression due to hematoma within the first postoperative 10 days
- Secondary Outcome Measures
Name Time Method Postoperative wound infection: Infection within the first 30 days requiring any of the following: Extra outpatient follow-up, re-operation, or revision or antibiotic treatment. Postoperative wound infection: 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: Wound rupture within the first 30 days requiring any of the following: Extra outpatient follow-up, re-operation, or revision. Postoperative wound rupture: Wound rupture within the first 30 days requiring any of the following: Extra outpatient follow-up, re-operation, or revision.
Thromboembolic events defined as thrombophlebitis, deep venous thrombosis, pulmonary embolus, cerebral or coronary infarctions until 30 days postoperatively. Thromboembolic events defined as thrombophlebitis, deep venous thrombosis, pulmonary embolus, cerebral or coronary infarctions until 30 days postoperatively.
Seroma defined as the need for aspiration of fluids, or spontaneous evacuation of voluminous fluids, between 10 and 30 days postoperatively. Seroma defined as the need for aspiration of fluids, or spontaneous evacuation of voluminous fluids, between 10 and 30 days postoperatively.
Other possible adverse effects causing contact with the health service until 30 days postoperatively. Other possible adverse effects causing contact with the health service until 30 days postoperatively.
Trial Locations
- Locations (11)
Helse Stavanger HF
🇳🇴Stavanger, Norway
Sykehuset Telemark HF
🇳🇴Skien, Norway
Universitetssykehuset Nord-Norge HF
🇳🇴Tromsoe, Norway
Haraldsplass Diakonale Sykehus AS
🇳🇴Bergen, Norway
Sykehuset Innlandet HF
🇳🇴Brumunddal, Norway
Helse Bergen HF
🇳🇴Bergen, Norway
Helse Moere Og Romsdal HF
🇳🇴Aalesund, Norway
Vestre Viken HF
🇳🇴Drammen, Norway
St. Olavs Hospital HF
🇳🇴Trondheim, Norway
Oslo University Hospital HF
🇳🇴Oslo, Norway
Scroll for more (1 remaining)Helse Stavanger HF🇳🇴Stavanger, NorwayKristin FurholtSite contact+4751558500kristin.ochoa.furholt@sus.no