[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600126":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":61,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Urinary catheter securement with adhesive device","EXPERIMENTAL","* Site of catheter securement: The urinary catheter will be secured on the anterior aspect of the thigh. The exact placement site will be chosen with the patient's leg bent, to ensure that the securement allows for future leg movement without causing tension or pulling on the catheter.\n* Catheter anchoring method: In female patients, the catheter will be anchored at the \"Y\" junction of the urinary catheter. In male patients, since the external portion of the catheter is shorter, the anchoring will be done just after the sampling port of the urine collection system.\n* Skin protection: Before applying the adhesive, a protective barrier spray (Cavilon® spray, 3M) will be applied to the selected skin area to prevent potential skin injury\n* Application: The device will be applied following the manufacturer's instructions.\n* Replacement: The device will be changed every 72 hours or sooner if needed. The thigh used for securement will be alterned at every change.",[13],"Device: GRIP-LOK FOLEY SECUREMENT DEVICE ®",{"label":15,"type":10,"description":16,"interventionNames":17},"Urinary catheter securement with elastic device","* Site of catheter securement: The urinary catheter will be secured on the anterior aspect of the thigh. The exact placement site will be selected with the patient's leg bent, to ensure that the securement allows for subsequent leg movement without causing pulling or tension on the catheter.\n* Catheter anchoring method: In female patients, the catheter will be anchored at the \"Y\" junction of the urinary catheter. In male patients, since the external portion of the catheter is shorter, the anchoring will be done just after the sampling port of the urine collection system.\n* Skin protection: The elastic band will be adjusted appropriately to minimize catheter movement while allowing normal blood circulation in the limb.\n* Application: The device will be applied following the manufacturer's instructions.\n* Replacement:The device will be changed every 72 hours, or sooner if necessary. The thigh used for securement will be alternated at every change",[18],"Device: CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETER",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","GRIP-LOK FOLEY SECUREMENT DEVICE ®","* Used device: adhesive\n* Specific Skin protection: with non alcohol barrier film",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETER","The elastic wristband will be adjusted appropriately to minimize catheter movement while allowing normal blood circulation in the limb.",[15],[31],{"name":32,"affiliation":5,"role":33},"Neus Calpe Damians, PhD","STUDY_DIRECTOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+34 932 91 90 00","ncalpe@santpau.cat",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Mireia Llauradó Serra, PhD","+34665033050","mireia.llaurado@ub.edu",[44],{"facility":45,"status":46,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Institut de Recerca Sant Pau","RECRUITING","Barcelona","08024","Spain","ES",{"type":52,"coordinates":53},"Point",[54,55],2.15899,41.38879,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":60,"phoneExt":25,"email":38},"Neus Calpe, PhD, MsN, RN","+34 680572768",{"type":62,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[64],{"name":65,"class":6},"Hospital de la Santa creu i Sant Pau - Barcelona","100600126","adhesive-devices-versus-elastic-devices-for-urinary-catheter-securement-in-critically-ill-patients-experimental-study-100600126",false,"NCT07093437","Adhesive Devices Versus Elastic Devices for Urinary Catheter Securement in Critically Ill Patients Experimental Study","Dispositivos Adhesivos Frente a Dispositivos elásticos Para la sujeción de la Sonda Urinaria en el Paciente crítico Estudio Experimental","Inclusion Criteria:\n\n* Age \\> 18 years\n* Pacients with an urinary catheter inserted within the past 24 hours\n* Expected duration of catheterization \\>48 hours\n* Estimated ICU lenght os stay \\> 48 hours\n\nExclusion Criteria:\n\n* Known allergy to adhesive tape\n* Patients with lesions at the urinary meatus, ongoing urinary tract infection or suspected infection\n* Presence of urological or prostatic pathology\n* Any condition that prevents securing the urinary catheter to the thigh, such as wounds, burns, or amputations","ALL","18 Years","99 Years",{"count":77,"type":78},188,"ESTIMATED","INTERVENTIONAL",[81],"NA","Nowadays there are two types of urinary catheter securement devices, adhesive and elastic bands. The goal of this clinical trial is to determine which type of device-adhesive or elastic-is more effective for securing urinary catheters in critically ill patients. The study also aims to evaluate the prevention of urethral meatus injuries, patient discomfort, and the incidence of catheter-associated urinary tract infections .\n\nThe main questions the trial aims to answer are:\n\n* Which device type better prevents injuries to the urethral meatus?\n* Which device reduces discomfort for patients?\n* Which device lowers the incidence of catheter-associated urinary tract infections?\n\nParticipants will:\n\n* Use either an adhesive or an elastic device to secure their urinary catheter during their stay in critical care\n* Be monitored regularly to assess any injuries, discomfort, or infections related to the catheter\n* Provide feedback on their comfort and any complications experienced, if they are able to communicate",[84,85,86,87],"Pressure Injuries","Pain","Catheter-Associated Urinary Tract Infection","Medical Device Site Injury",[89,90,91,92,93],"Urinary catheter securement","Urinary catheter fixation","Catheter-associated urinary tract infections","pain","Meatal pressure injuries","2025-12-03",{"date":96,"type":97},"2025-12-10","ACTUAL",{"date":99,"type":97},"2025-09-22",{"date":101,"type":78},"2026-10-30",{"name":5,"class":6},1]