IDEAL SKIIN CARES Bundle to Prevent Pressure Injury

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorBaqiyatallah Medical Sciences University

About this trial

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.

Eligibility criteria

Qualifiers

be adults aged 18 years or older;

have been hospitalized for a minimum of 48 hours;

be willing to participate.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • IDEAL SKIIN CARES bundles
  • IDEAL SKIIN CARES bundles workshop
  • Respiratory care workshop

Treatment groups

1,620 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Baqiyatallah Medical Sciences University

Lead sponsor

Tehran University of Medical Sciences

Collaborator

Hamadan University of Medical Science

Collaborator

Tabriz University of Medical Sciences

Collaborator