Status:
COMPLETED
Prevention of Incontinence-associated Dermatitis and Maintenance of Local Skin Microclimate
Lead Sponsor:
Sir Run Run Shaw Hospital
Conditions:
Incontinence-associated Dermatitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 u...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06509932
Start Date
July 1 2024
End Date
October 10 2024
Last Update
May 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016