The Effect of Topical Tranexamic Acid on Postoperative Complications in Soft Tissue Plastic Surgery. A Multicenter Randomized Controlled Trial

270777

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.

2024-05-01

2028-12-31

2029-12-31

Not yet recruiting

Early phase I

3000

Inclusion Criteria: * Patients are eligible to be included in the study only if all of the following criteria apply: 1. 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. 2. They are over 18 years of age and capable of independently providing informed consent 3. They 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. Insufficient knowledge of national language or English.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Randomized controlled prospective interventional trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Identically shaped ampoules containing traneamic acid (Cyklokapron, Pfizer) and 0.9% NaCl (Lavoisier, France) have been identified. The ampoule top part is camouflaged with a tight-fitting black tube which preserves the breaking point on the neck of the ampoule. The ampoules will be re-labeled with study-specific labels (text will be in accordance with Regulation 546/2014, annex VI). Randomized study envelopes will be provided in packages of two, with a 1:1 TXA:Placebo randomization, enabling a within-patient randomization in bilateral procedures.\n\nRandomization, blinding, labelling, shipment of ampoules and keeping of the randomization code will be done by Smerud Medical Research International AS.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 3000, 'type': 'ESTIMATED'}}

2024-02-21