Clinical Research Directory
Browse clinical research sites, groups, and studies.
IDEAL SKIIN CARES Bundle to Prevent Pressure Injury
Sponsor: Baqiyatallah Medical Sciences University
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.
Official title: Effect of IDEAL SKIIN CARES Bundle to Prevent Hospital-acquired Pressure Injury: A Cluster Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
1620
Start Date
2025-10-01
Completion Date
2027-10-01
Last Updated
2024-04-17
Healthy Volunteers
Yes
Interventions
IDEAL SKIIN CARES bundles
The investigators developed a specialized PIP care bundle, named IDEAL SKIIN CARES, through extensive review of literature and expert insights, which will be utilized for training WSNs and patients in the intervention group. This comprehensive bundle comprises 15 key components aimed at effectively preventing PIs: (1) Incontinence care status; (2) Dehydration status; (3) Elevate at-risk surfaces; (4) Attention to attached devices to skin; (5) Lotion use; (6) Skin assessment; (7) Keeping repositioning; (8) Individualized up-to-date knowledge; (9) Individualized medical devices selection; (10) Nutrition status; (11) Caregiver (formal and informal) participation; (12) Activity assessment; (13) Reducing friction/shear forces; (14) Evaluate hemodynamic instability; (15) and Scrutinizing comorbidities.
IDEAL SKIIN CARES bundles workshop
IDEAL SKIIN CARES bundles will be explained in detail by a trained research assistant in a workshop. This workshop is different from clinical training and following up about the IDEAL SKIIN CARES bundles.
Respiratory care workshop
An unrelated topic, specifically respiratory care will be held in a workshop. This training will involve the distribution of educational pamphlets, brochures, and visual posters outlining key aspects of respiratory care