protocolSection identificationModule nctId: NCT06270407, orgStudyIdInfo id: 270777, secondaryIdInfos id: 2022-001580-28, type: EUDRACT_NUMBER, secondaryIdInfos id: 2023-510381-28-00, type: REGISTRY, domain: CTIS European Clinical Trial Identification System, briefTitle: The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-12-31, completionDateStruct date: 2029-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: St. Olavs Hospital, class: OTHER, collaborators name: Smerud Medical Research International AS, collaborators name: Sykehuset Asker og Baerum, collaborators name: Oslo universitetssykehus HF, collaborators name: Sykehuset Telemark, collaborators name: Sykehuset Innlandet HF, collaborators name: Molde Hospital, collaborators name: Haukeland University Hospital, collaborators name: Haraldsplass Deaconess Hospital, collaborators name: Helse Stavanger HF, collaborators name: University Hospital of North Norway, collaborators name: Bodø sykehus, collaborators name: Helsinki University Central Hospital, descriptionModule briefSummary: 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., conditionsModule conditions: Surgical Complication, designModule 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.Randomization, blinding, labelling, shipment of ampoules and keeping of the randomization code will be done by Smerud Medical Research International AS., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: Tranexamic Acid 100 MG/ML, interventions name: 0.9%sodium chloride, outcomesModule primaryOutcomes measure: Postoperative re-bleeding, secondaryOutcomes measure: Postoperative wound infection, secondaryOutcomes measure: Postoperative wound rupture, secondaryOutcomes measure: Postoperative thromboembolic events, secondaryOutcomes measure: Postoperative seroma, secondaryOutcomes measure: Any other postoperative complication, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False