NCT06369688

IDEAL SKIIN CARES Bundle to Prevent Pressure Injury

Effect of IDEAL SKIIN CARES Bundle to Prevent Hospital-acquired Pressure Injury: A Cluster Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,620 (estimated)
• Sponsor: Baqiyatallah Medical Sciences University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed description

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 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. These components are categorized into three groups to facilitate understanding and enhance patient engagement in PIP care: (1) Education; (2) assessment of patient's condition; and (3) Care intervention. Therefore, the investigators will conduct a c-RCT with three arm parallel design for hospitalized patients to assessed the effect of IDEAL SKIIN CARES bundle to prevent of occurrence HAPI in three groups of study and compare with routine standard care for PIP care bundle.

Conditions

• Pressure Ulcer
• Pressure Injury
• Bed Sore
• Pressure Sore
• Decubitus Sore
• Decubitus Ulcer
• Skin Ulcer

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.
OTHER	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

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2024-04-17
• Last updated: 2024-04-17