Prevention of Incontinence-associated Dermatitis and Maintenance of Local Skin Microclimate:A Multicenter Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSir Run Run Shaw Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Jefcare Sterile Medical Sheets

    Device

    Screening 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

    Device

    Screening 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

125 Participants
are divided into 2 treatment groups
Group A: Molicare Premium Bed MatOther 1 intervention
Group B: Jefcare Sterile Medical SheetsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of IAD

incidence of IAD = number of cases of patients with IAD in the group/total number of patients in the group × 100%.

Time frame
Follow-up on Day 2, Day 3, Day 4, and Day 5 of the intervention until the start of the IAD/end of the study i.e. day 5 of the intervention.

Secondary outcomes

1

The time of IAD occurrence

Time to IAD after enrolment

Time frame
Follow-up on Day 2, Day 3, Day 4, and Day 5 of the intervention until the start of the IAD/end of the study i.e. day 5 of the intervention.
2

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.

Time frame
Follow-up on Day 2, Day 3, Day 4, and Day 5 of the intervention until the start of the IAD/end of the study i.e. day 5 of the intervention
3

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.

Time frame
Total 2 times. 1 prior to intervention, 1 on occurrence of IAD or end of the study i.e. day 5 of the intervention.
4

The skin microclimate and skin barrier function

Examination indicators: Temperature of sheets

Time frame
Total 2 times. 1 prior to intervention, 1 on occurrence of IAD or end of the study i.e. day 5 of the intervention.

Other outcomes

Locations

This trial has no 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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