Prevention of Incontinence-associated Dermatitis and Maintenance of Local Skin Microclimate

Last updated: July 14, 2024
Sponsor: Sir Run Run Shaw Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eczema (Atopic Dermatitis - Pediatric)

Allergy

Rash

Treatment

Jefcare Sterile Medical Sheets

MoliCare Premium Bed Mats

Clinical Study ID

NCT06509932
20240161
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Intensive care unit incontinent patients (incontinence time ≥2 days)

  2. Age ≥18 years

  3. patients at high risk of IAD (Perineal Assessment Tool ≥ 7)

  4. Voluntarily participate in the study and sign an informed consent form. If thesubject is unable to read and sign the informed consent form due to incapacitationor other reasons, their guardian is required to represent the informed process andsign the informed consent form. If the subject is unable to read the informedconsent form (e.g., illiterate subjects), a witness will be required to witness theinformed process and sign the informed consent form.

Exclusion

Exclusion Criteria:

  1. Patients who have developed IAD

  2. Expected subsequent stay in the intensive care unit <5 days

  3. Use of nappies, pull-ups, incontinence pads, etc.

  4. Simple urinary incontinence with indwelling catheterization, external urinary bagwithout leakage; simple fecal incontinence with built-in drainage device, externalostomy bag, OB tampon without leakage; double incontinence with indwellingcatheterization, external urinary bag, built-in drainage device, external ostomybag, OB tampon without leakage.

  5. The IAD may affect the skin area within the scope of the disease that affects theIAD judgment.

  6. The IAD may affect the skin area within the scope of the skin breaks, infection

  7. Patients who are not suitable for turning and cannot tolerate the side-lyingposition.

  8. Patients with known allergies or keloid scarring

  9. Women who are known to be pregnant or breastfeeding or who are planning to have ababy during the study period.

  10. Patients who have participated in a clinical trial of another drug or medical devicewithin 3 months.

  11. Patients who, in the opinion of the investigator, are not suitable for participationin this clinical trial.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Jefcare Sterile Medical Sheets
Phase:
Study Start date:
July 01, 2024
Estimated Completion Date:
October 10, 2024

Study Description

Jefcare Sterile Medical Sheet is an incontinence care product designed by researchers following the Expert consensus on the clinical application of disposable absorbent care products for adults with incontinence. The product has good laboratory test indicators and has the potential to prevent incontinence-associated dermatitis and maintain the stability of the local skin microclimate. Still, there is a lack of high-quality clinical studies.

Connect with a study center

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310016
    China

    Active - Recruiting

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