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Not yet recruiting NCT06369688

IDEAL SKIIN CARES Bundle to Prevent Pressure Injury

No phase Interventional Pressure Ulcer Pressure Injury Bed Sore Pressure Sore

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IDEAL SKIIN CARES bundles, IDEAL SKIIN CARES bundles workshop, Respiratory care workshop.
Who it may be relevant to
Registry conditions: Pressure Ulcer, Pressure Injury, Bed Sore, Pressure Sore. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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 repositi
  • 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

Primary outcome measures

  • Incidence of hospital-acquired pressure injury (HAPI) [Time frame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days]
Secondary outcome measures (4)
  • Pressure Injury Stage [Time frame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days]
  • Patient participation in care [Time frame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days]
  • Healthcare costs [Time frame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days]
  • Self-report Patient participation in care [Time frame: Within 48 hours of hospital admission until they reach the trial endpoints of hospital discharge or 28 days]

Eligibility criteria

Inclusion criteria

  • be adults aged 18 years or older;
  • have been hospitalized for a minimum of 48 hours;
  • be willing to participate.

Exclusion criteria

  • patients with significant pre-existing skin conditions or injuries that make it difficult to observe skin integrity;
  • have existing PIs or vascular ulcers upon admission to the hospital (pressure injuries defined by the National Pressure Ulcer Advisory Panel);
  • be at risk of PIs due to limited mobility (requiring physical or mechanical assistance to reposition or move);
  • individuals with urinary or fecal incontinence, mental illness, or severe cognitive impairment upon hospital admission;
  • patients who are hospitalized in day-surgery, critical care, emergency, maternity, pediatrics, mental health and dialysis units;
  • admitted to the hospital for >28 days;
  • those with prior experience of PIs or training in PIs care and prevention.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Bahramnezhad F, Probst S, Moradi A, Gohari-Moghadam K, Rahimi-Bashar F, Mahmoodpoor A, Ghamari AA, Jafari I, Vahedian-Azimi A, Pokorna A. Development and validation of the Pressure Injury after Hospital Admission (PIAHA) screening tool for early assessment of hospital-acquired pressure injuries: a multiphase multicentre study protocol in acute care settings. BMJ Open. 2026 Mar 26;16(3):e114550. do PMID 41887642

Identifiers

NCT: NCT06369688 · Baqiyatallah University

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗