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

Official title

Effect of Different Types of Disposable Absorbent Sheets on the Local Skin Microclimate and Incidence of Incontinence-associated Dermatitis in Patients With Incontinence in the ICU: a Multicenter Randomized Controlled Trial

Overview

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.

Interventions

• Device 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.
• Device 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.

Primary outcome measures

• Incidence of IAD [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 outcome measures (7)

• The time of IAD occurrence [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.]
• The site and severity of IAD occurrence [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]
• The skin microclimate and skin barrier function [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.]
• The skin microclimate and skin barrier function [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.]
• Date of faecal incontinence (post-intervention);Mean number of faecal incontinence per day (post-intervention). [Time frame: 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.]
• Average daily cost-effectiveness of medical sheets. [Time frame: 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 [Time frame: Total 2 times. 1 prior to intervention, 1 on occurrence of IAD or end of study i.e. day 5 of the intervention.]

Eligibility criteria

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
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06644027 · 20240455

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗