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

NCT06509932 | Completed

• 1 other identifier: 20240161
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Incontinence-associated Dermatitis

Outcome Measures

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%.

  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 (5)

• The time of IAD occurrence

  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.

• The site and severity of IAD occurrence

  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.

• The skin microclimate and skin barrier function

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

• Date of faecal incontinence (ICU admission to end of study);Mean number of faecal incontinence per day (ICU admission to end of study);The average number of medical sheets used per day.

  The average number of medical sheets used per day: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.

• Mycological examination

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

Study Arms (2)

Jefcare Sterile Medical Sheets

EXPERIMENTAL

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.

Device: Jefcare Sterile Medical Sheets

Molicare Premium Bed Mat

OTHER

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.

Device: MoliCare Premium Bed Mats

Interventions

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.

Jefcare Sterile Medical Sheets

MoliCare Premium Bed Mats 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.

Molicare Premium Bed Mat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Women who are known to be pregnant or breastfeeding or who are planning to have a baby during the study period.
• Patients who have participated in a clinical trial of another drug or medical device within 3 months.
• Patients who, in the opinion of the investigator, are not suitable for participation in this clinical trial.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Study Officials

• Hongyang Hu

  Sir Run Run Shaw Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 19, 2024
• Study Start: July 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 10, 2024
• Last Updated: May 14, 2025

Record last verified: 2024-07

Locations

CN (1)