The Effect of Topical Tranexamic Acid on Postoperative Complications in Soft Tissue Plastic Surgery. A Multicenter Randomized Controlled Trial
Phase 1
- Conditions
- Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Registration Number
- CTIS2023-510381-28-01
- Lead Sponsor
- St. Olavs Hospital HF
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3000
Inclusion Criteria
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 .
Exclusion Criteria
Patients with known allergy to tranexamic acid.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: Secondary objectives are to investigate whether the procedure affects the incidence of wound infection, wound rupture, postoperative seroma or thromboembolic events needing intervention within 30 days after surgery. Estimands are the occurrence or absence of such incidents within the defined time periods.;Primary end point(s): 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 Secondary end point(s):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.;Secondary end point(s):Postoperative wound rupture: Wound rupture within the first 30 days requiring any of the following: Extra outpatient follow-up, re-operation, or revision.;Secondary end point(s):Thromboembolic events defined as thrombophlebitis, deep venous thrombosis, pulmonary embolus, cerebral or coronary infarctions until 30 days postoperatively.;Secondary end point(s):Seroma defined as the need for aspiration of fluids, or spontaneous evacuation of voluminous fluids, between 10 and 30 days postoperatively.;Secondary end point(s):Other possible adverse effects causing contact with the health service until 30 days postoperatively.