Incontinence-associated Dermatitis, Pressure Ulcers
Conditions
Keywords
Repositioning, Incontinence care, Prevention
Brief summary
The prevalence of pressure ulcer in hospitals is 7,3% - 23%. The primary etiological factors are pressure or pressure combined with shear. Prevention is very important and comprises: preventive skin care including cleansing and protecting the skin from exposure to moisture, the systematic repositioning of the patient, the offloading of the heels from the surface of the bed, the use of adequate bed support surfaces and an adequate nutritional status. The development and implementation of a risk based prevention plan for individuals identified as being at risk is strongly recommended. Limited compliance exists towards pressure ulcer preventive interventions. 25,5% of the patients at risk receive fully adequate prevention in bed. The reposition frequence is adequate in 55% of patients at risk. There is a lack of rigorously performed research addressing the effectiveness of devices or risk based protocols to improve compliance. Health care budgets are limited, priorities should be set in the allocation of health care resources. The primary aim of this study is to compare the effectiveness of the turn and position system (Prevalon®Turn and Position System 2.0, SAGE) versus standard care to improve reposition frequence in patients at risk. The second aim is to compare the effectiveness of a tailored protocol versus standard care to improve reposition frequence in patients at risk. The third aim is to compare the effectiveness of standardized incontinence care versus standard care to improve the incidence of pressure ulcers and incontinence-associated dermatitis (IAD). Also a health economic evaluation will be performed. The study will be performed in hospital setting (university and general hospitals) in a random sample of 226 patients aged \> 18 who are at risk of developing pressure ulcers. Patients will be recruited from three types of wards: intensive care units, geriatric wards and rehabilitation wards. Patients will be included in the study for a period of 8 days.
Interventions
PROCEDUREA protocol tailored to individual risk factors
DEVICEThe Prevalon® Turn and Position System 2.0
DEVICEComfort Shield® barrier cream cloths
Sponsors
Sage Products, LLC
University Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* At risk of developing pressure ulcers (Braden score \< 17) * Maximum 24hours admitted on the ward at the time of inclusion * Expected lenght of stay: 8 days * Free of pressure ulcers category II, II, IV and incontinence-associated dermatitis (IAD) category 2 at the start of the study
Exclusion criteria
\- Patients with no active or supportive therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Turning compliance of nurses within the trial period as assessed by the researcher (unannounced) | within 8 days after the start of the study | The researcher wil collect and administer data about turning compliance and compliance with the protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Turning angle | within 8 days after the start of the study | Per patient the researcher will measure two times the turning angle in which the patient is positioned. |
| Sacrum free of pressure | within 8 days after the start of the study | Per patient the researcher will investigate two times if the sacrum is free of pressure while the patient is positioned. |
| Incidence of pressure ulcers and incontinence-associated dermatitis | within 8 days after the start of the study | — |
| Comfort and preferences of the caregiver | On baseline and at day 8 (the end of the study) | Questions on comfort and preferences of the TAP, comfort shield barrier cream cloths and tailored repositioning will be assessed. At baseline these questions will assess the traditional care. |
| Comfort and tolerance of the patient | At day 8 (the end of the study) | Questions on comfort and tolerance of the TAP, comfort shield barrier cream cloths and repositioning will be assessed by the caregiver. At baseline these questions will assess the traditional care. |
| Cost-effectiveness of the prevention of pressure ulcers | For the duration of the study (8 days) | The following costs will be calculated to provide insight concerning cost-effectiveness: Objective time analysis of repositioning (by using a chronometer), Subjective time analysis of repositioning, Daily consumption of comfort shield barrier cream cloths and microclimate body pads |
Countries
Belgium
Outcome results
None listed