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

NCT ID: NCT06509932

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2024-10-10

Brief 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.

Detailed 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.

Conditions

Incontinence-associated Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Jefcare Sterile Medical Sheets

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.

Group Type: EXPERIMENTAL

Jefcare Sterile Medical Sheets

Intervention Type: 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

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.

Group Type: OTHER

MoliCare Premium Bed Mats

Intervention Type: 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.

Interventions

Jefcare Sterile Medical Sheets

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.

Intervention Type: DEVICE

MoliCare Premium Bed Mats

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.

Intervention Type: DEVICE

Eligibility Criteria

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 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

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 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.

5. The IAD may affect the skin area within the scope of the disease that affects the IAD 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-lying position.

8. Patients with known allergies or keloid scarring

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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongyang Hu

Role: STUDY_CHAIR

Sir Run Run Shaw Hospital

Locations

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

20240161

Identifier Type: -

Identifier Source: org_study_id