Clinical Trial

IDEAL SKIIN CARES Bundle to Prevent Pressure Injury

Study acronym: IdealSkinCares
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT06369688
Lead Sponsor Baqiyatallah Medical Sciences University
Collaborators: Tehran University of Medical Sciences, Hamadan University of Medical Science, Tabriz University of Medical Sciences
Conditions Pressure Ulcer, Pressure Injury, Bed Sore, Pressure Sore, Decubitus Sore, Decubitus Ulcer, Skin Ulcer
Enrollment 1,620 participants
Start Date 2025-10-01
Primary Completion 2026-10-01 (estimated)
Study Completion 2027-10-01 (estimated)
Updated on ClinicalTrials.gov 2024-04-17