PIDComparison of Film-forming and Lipophilic Skin Protectants for Prevention of Incontinence-associated Dermatitis in Elderly Care
This study aims to compare the effectiveness of film-forming and lipophilic skin protectants in preventing Incontinence-associated Dermatitis (IAD) in the elderly, by observing the incidence and severity of IAD according to the Ghent Global IAD Categorisation Tool (GLOBIAD).
ESENTA™ Skin Barrier Spray (ConvaTec, UK)
+ Hydrophobes Basisgel DAC
Erythema+3
+ Signs and Symptoms
+ Skin Diseases
Prevention Study
Summary
Study start date: August 19, 2022
Actual date on which the first participant was enrolled.This study focuses on a skin condition called incontinence-associated dermatitis (IAD). IAD is a skin inflammation caused by prolonged contact with urine and/or stool, commonly affecting elderly and care-dependent individuals who experience incontinence. The goal of this research is to compare the effectiveness of two different skin protection products in preventing IAD, as currently, there's no clear evidence favoring one product over another. The study involves elderly nursing home residents and geriatric patients in Berlin, Germany, who are over 65 years old and experience urinary and fecal incontinence, but do not show severe IAD symptoms. The importance of this study lies in its potential to improve skin care routines and prevent IAD in the elderly population. During the 14-day study, participants are randomly divided into two groups. Each group receives a different skin protection product, either film-forming or lipophilic, in addition to their standard skin care routine. Every other day, investigators examine the skin and measure redness using special instruments. They also assess any IAD-related pain and itching. The primary outcome of the study is to determine the number of participants who develop IAD. The severity of IAD is classified using the Ghent Global IAD Categorisation Tool (GLOBIAD), which ranges from persistent redness without infection to skin loss with infection.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.220 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Charité Universitätsmedizin Berlin
Berlin, GermanyOpen Charité Universitätsmedizin Berlin in Google Maps