IDEAL SKIIN CARES Bundle to Prevent Pressure Injury

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• Tehran University of Medical Sciences

  collaborator OTHER

• Hamadan University of Medical Science

  collaborator OTHER

• Tabriz University of Medical Sciences

  collaborator OTHER

• Baqiyatallah Medical Sciences University

  lead OTHER

Principal Investigators

• Amir vahedian-azimi, Professor · Baqiyatallah University of Medical Sciences, Tehran, Iran.

• Keivan Goharimoghadam, Professor · Tehran University of Medical Scienecs, Tehran, Iran

• Farshid Rahimi-bashar, Professor · Hamadan University of Medical Sciences, Hamadan, Iran.

• Ata Mahmoodpoor, Professor · Tabriz university of Medical Sciences, Tabriz, Iran.

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2026-10-01

Completion

2027-10-01