protocolSection identificationModule nctId: NCT06369688, orgStudyIdInfo id: Baqiyatallah University, briefTitle: IDEAL SKIIN CARES Bundle to Prevent Pressure Injury, acronym: IdealSkinCares, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-10-01, primaryCompletionDateStruct date: 2026-10-01, completionDateStruct date: 2027-10-01, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Baqiyatallah Medical Sciences University, class: OTHER, collaborators name: Tehran University of Medical Sciences, collaborators name: Hamadan University of Medical Science, collaborators name: Tabriz University of Medical Sciences, descriptionModule briefSummary: The study will be a multi-center, triple-blinded, cluster randomized controlled trial (c-RCT) conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group, where patients will receive training in relevant pressure injury care bundles, and the placebo group, where patients will receive training in an irrelevant topic like respiratory care. Both intervention and placebo groups will receive specialized pressure injury prevention (PIP) care bundle from trained wound specialist nurses (WSNs). The third arm will be the control group comprising patients who do not undergo any training course and will receive only routine standard care for PIP care bundle. The aim of c-RCT will be to compare the incidence of hospital-acquired pressure injury (HAPI) in the three study groups and to provide detailed evidence on the effect of the developed pressure injury care bundle, administered by WSNs on the development of HAPI in trained hospitalized patients, as opposed to those receiving routine standard care for PIP care bundle without training., conditionsModule conditions: Pressure Ulcer, conditions: Pressure Injury, conditions: Bed Sore, conditions: Pressure Sore, conditions: Decubitus Sore, conditions: Decubitus Ulcer, conditions: Skin Ulcer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: C-RCT will be conducted with a three-arm parallel design and a 1:1:1 allocation ratio. The experimental groups will consist of two arms: the intervention group and the placebo group. The third arm will be the control group., primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: In this placebo-controlled trial, patients will be blinded to their group allocations. Additionally, WSNs, who are trained for delivering special PIP care bundles, as well as nursing staff who are responsible for measuring wounds and collecting data, and data analyst, will also be blinded., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1620, type: ESTIMATED, armsInterventionsModule interventions name: IDEAL SKIIN CARES bundles, interventions name: IDEAL SKIIN CARES bundles workshop, interventions name: Respiratory care workshop, outcomesModule primaryOutcomes measure: Incidence of hospital-acquired pressure injury (HAPI), secondaryOutcomes measure: Pressure Injury Stage, secondaryOutcomes measure: Patient participation in care, secondaryOutcomes measure: Healthcare costs, secondaryOutcomes measure: Self-report Patient participation in care, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False