Not Yet RecruitingNot Applicable

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

125 participantsStarted 2024-10-10

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.
✕. The IAD may affect the skin area within the scope of the disease that affects the IAD judgment.
✕. The IAD may affect the skin area within the scope of the skin breaks, infection
✕. Patients who are not suitable for turning and cannot tolerate the side-lying position.
✕. Patients with known allergies or keloid scarring

What they're measuring

Incidence of IAD

Timeframe: 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.

Trial details

NCT IDNCT06644027

SponsorSir Run Run Shaw Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-10

Contact for this trial

hongyang Hu

13858142984 3193174@zju.edu.cn

View on ClinicalTrials.gov More Incontinence-associated Dermatitis trials