Clinical Trials Logo
  1. Home
  2. Skin Ulcer
  3. NCT06369688

IDEAL SKIIN CARES Bundle to Prevent Pressure Injury — IdealSkinCares  

Pressure Ulcer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06369688
Study type Interventional
Source Baqiyatallah Medical Sciences University
Contact Amir vahedian-azimi, Professor
Phone 09196017138
Email amirvahedian63@gmail.com
Status Not yet recruiting
Phase N/A
Start date October 1, 2025
Completion date October 1, 2027
View Details
See also
  Status Clinical Trial Phase
Completed NCT03351049 - An RCT on Support Surfaces for Pressure Ulcer Prevention N/A
Completed NCT05112068 - Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients
Completed NCT05575869 - Evaluation of the Impact of the PRONEtect Education Hub vs. Classic Lecture, on the Competencies of Nursing Students N/A
Completed NCT03220451 - Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients N/A
Terminated NCT05234632 - Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds N/A
Completed NCT04540822 - Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care N/A
Terminated NCT01966380 - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia Phase 2
Completed NCT02092870 - Adipose Derived Regenerative Cellular Therapy of Chronic Wounds Phase 2
Completed NCT01438541 - A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration Phase 4
Completed NCT00365430 - SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes N/A
Completed NCT04251897 - Novel Support Surface to Alleviate Pressure Ulcer N/A
Completed NCT03391310 - Use of Honey for Pressure Ulcers in Critically Ill Children N/A
Recruiting NCT04559165 - Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore N/A
Completed NCT05646121 - Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
Not yet recruiting NCT06421454 - Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers N/A
Terminated NCT05547191 - Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement N/A
Completed NCT05458050 - An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers N/A
Active, not recruiting NCT03048357 - Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury. N/A
Completed NCT06025370 - Pressures During Prone Positions in Healthy Volunteers N/A
Recruiting NCT05033470 - A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers N/A