About this trial
To explore the feasibility of Jefcare Sterile Medical Sheets in preventing incontinence-associated dermatitis and maintaining a stable local skin microclimate in adult patients in the intensive care unit.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Intensive care unit incontinent patients (incontinence time ≥2 days)
Age ≥18 years
patients at high risk of IAD (Perineal Assessment Tool ≥ 7)
Voluntarily participate in the study and sign an informed consent form. If the subject is unable to read and sign the informed consent form due to incapacitation or other reasons, their guardian is required to represent the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (e.g., illiterate subjects), a witness will be required to witness the informed process and sign the informed consent form.
Disqualifiers
Patients who have developed IAD
Expected subsequent stay in the intensive care unit <5 days
Use of nappies, pull-ups, incontinence pads, etc.
Simple urinary incontinence with indwelling catheterization, external urinary bag without leakage; simple fecal incontinence with built-in drainage device, external ostomy bag, OB tampon without leakage; double incontinence with indwelling catheterization, external urinary bag, built-in drainage device, external ostomy bag, OB tampon without leakage.
Trial design
Parallel
Treatments tested in this trial
Jefcare Sterile Medical Sheets
DeviceScreening period (day 0): normal routine medical sheet and skin care regimen. Intervention days 1, 2, 3, 4, 5: Jefcare Sterile Medical Sheets and skin care regimen.
Molicare Premium Bed Mat
DeviceScreening period (day 0): normal routine medical sheet and skin care regimen. Intervention days 1, 2, 3, 4, 5: MoliCare Premium Bed Mats and skin care regimen.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of IAD
incidence of IAD = number of cases of patients with IAD in the group/total number of patients in the group × 100%.
Secondary outcomes
The time of IAD occurrence
Time to IAD after enrolment
The site and severity of IAD occurrence
IAD may affect a range of 14 skin regions. A patient was considered to have IAD onset as long as the patient had IAD in 1 place. Using the IAD categorization tool, the tool classifies the severity of IAD into 3 levels. level 0 is represented by intact skin, no redness, and no difference in comparison to the skin of other body parts. level 1 is represented by red, intact, and possibly erythematous skin with edema. level 2 is represented by red, broken, and possibly skin with edema, blisters, blisters, vesicles, eruption of the skin, excoriation, and infected skin.
The skin microclimate and skin barrier function
Examination site: 3cm below the belly button;the lower abdomen/pubic arch; the inner right thigh; the inner left thigh ; the lower left buttock; the lower right buttock. Examination indicators: Skin temperature , skin hydration, skin PH , melanin , erythema , transepidermal water loss. Three measurements were taken at each site and averaged.
The skin microclimate and skin barrier function
Examination indicators: Temperature of sheets
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sir Run Run Shaw Hospital
Lead sponsor
Shaoxing People's Hospital
Collaborator
Jiangshan People's Hospital
Collaborator
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