Tokyo, May 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061680) titled 'A Retrospective Study on Interventions for Auricular Pressure Ulcers in Children and Adults with Severe Physical and Intellectual Disabilities and the Effects of Donut-Shaped Cushions' on May 25.
Study Type:
Observational
Primary Sponsor:
Institute - Shiga University of Medical Science
Condition:
Condition - Children (and adults) with severe physical and mental disabilities
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the clinical outcomes of an intervention using a donut-shaped cushion for treating pressure ulcers of the auricular region in children and adults with severe physical and mental disabilities.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 1
months-old
=
Gender - Male and Female
Key inclusion criteria - The study population consisted of approximately 200 patients admitted to Hospital A who were classified as extremely severely disabled children or adults, or near-extremely severely disabled children or adults, due to conditions such as cerebral palsy or hypoxic encephalopathy. These patients had severe physical disabilities and severe intellectual disabilities, and required continuous respiratory management, nutritional management, and repositioning. All patients had a WeeFIM score of 18. We will conduct a retrospective study of these patients to analyze the occurrence of pressure ulcers and associated risk factors.
Key exclusion criteria - None
Target Size - 200
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 04 Month 01 Day
Anticipated trial start date - 2025 Year 04 Month 01 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069739
Disclaimer: Curated by HT Syndication.
