Incontinence-associated DermatitisI-and-M-mNCT06644027
Prevention of Incontinence-associated Dermatitis and Maintenance of Local Skin Microclimate：A Multicenter Study
A study testing Jefcare Sterile Medical Sheets and Molicare Premium Bed Mat in people with Incontinence-associated Dermatitis, run by Sir Run Run Shaw Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incontinence-associated Dermatitis
- What is being tested?
- Jefcare Sterile Medical Sheets and Molicare Premium Bed Mat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2024to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet.
About this 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
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.
Read the 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
- Being tested
- Jefcare Sterile Medical Sheets, Molicare Premium Bed Mat
- Keywords
- incontinence-associated dermatitis, microclimate, Jefcare Sterile Medical Sheets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jefcare Sterile Medical SheetsDevice
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 MatDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Molicare Premium Bed Mat |
| 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. Receives: Device: Jefcare Sterile Medical Sheets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of IAD
incidence of IAD = number of cases of patients with IAD in the group/total number of patients in the group × 100%.
Measured: 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 (7)
The time of IAD occurrence
Time to IAD after enrolment
Measured: 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
IAD may affect a range of 14 skin regions. A patient was considered to have IAD onset as long as the patient had IAD in 1 place.
Using the IAD categorization tool, the tool classifies the severity of IAD into 3 levels. level 0 is represented by intact skin, no redness, and no difference in comparison to the skin of other body parts. level 1 is represented by red, intact, and possibly erythematous skin with edema. level 2 is represented by red, broken, and possibly skin with edema, blisters, blisters, vesicles, eruption of the skin, excoriation, and infected skin.
Measured: 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
Examination site: 3cm below the belly button；the lower abdomen/pubic arch; the inner right thigh; the inner left thigh ; the lower left buttock; the lower right buttock.
Examination indicators: Skin temperature , skin hydration, skin PH , melanin , erythema , transepidermal water loss. Three measurements were taken at each site and averaged.
Measured: 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
Examination indicators: Temperature of sheets
Measured: 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).
Date of fecal incontinence (post-intervention) = total number of days of fecal incontinence post-intervention.
Date of faecal incontinence (post-intervention) = Total number of fecal incontinence episodes post-intervention/total number of days of fecal incontinence post-intervention.
Measured: 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.
Average daily cost-effectiveness of medical sheets = average daily number of medical sheets used x cost of individual medical sheet.
Measured: 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
A cotton swab impregnated with saline sampling solution was applied to the local skin in a circular pattern from the upper left buttock, gluteal cleft, upper right buttock, lower right buttock, posterior right thigh, posterior left thigh, lower left buttock, and perineum in a sequential order, and the sampling cotton swabs were rotated accordingly, and the swabs were applied to the culture medium after sampling. Then to the front of the patient, a cotton swab was taken in a circular pattern from the lower abdomen/pubic arch, the left inguinal fold between the genitals and the thighs, the left inner thigh, the right inner thigh, the right inguinal fold between the genitals and the right thigh, and the genitals in the order of applying a localized skin and the subsequent rotation of the sampling cotton swab, and the swabs were applied to the culture medium after sampling. Observe for fungal growth and multiplication within the medium.
Measured: Total 2 times. 1 prior to intervention, 1 on occurrence of IAD or end of study i.e. day 5 of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start10 Oct 2024 (estimated)
- Primary completion10 Apr 2025 (estimated)
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence-associated DermatitisStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental: Jefcare Sterile Medical Sheets Other: Molicare Premium Bed Mat
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shaoxing People's Hospital, Jiangshan People's Hospital
- Responsible party
- Sponsor
- Investigators
- hongyang Hu, Study chair, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644027
- Sponsor's protocol ID
- 20240455
- Acronym
- I-and-M-m
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06644027
- Acronym / sponsor ID
- I-and-M-m / 20240455
- Conditions
- Incontinence-associated Dermatitis
- Keywords
- incontinence-associated dermatitis, microclimate, Jefcare Sterile Medical Sheets
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Collaborators
- Shaoxing People's Hospital, Jiangshan People's Hospital
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental: Jefcare Sterile Medical Sheets Other: Molicare Premium Bed Mat
| Arm | Type | Receives |
|---|---|---|
| Molicare Premium Bed Mat | Other | Device: Molicare Premium Bed MatScreening 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. |
| Jefcare Sterile Medical Sheets | Experimental | Device: Jefcare Sterile Medical SheetsScreening 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jefcare Sterile Medical SheetsScreening 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 MatScreening 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 Mat |
Primary outcome
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.
incidence of IAD = number of cases of patients with IAD in the group/total number of patients in the group × 100%.
7 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Incontinence-associated Dermatitis
Enrolling by invitation
Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.
Pressure Injury, Pressure Injury Prevention
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Testing the Safety and Efficacy of a Novel Barrier Cream for the Treatment of Moisture Associated Skin Damage
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Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
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Testing a Novel Barrier Cream for Fecal Incontinence in an Ambulatory Population
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hongyang Hu study chair
Sir Run Run Shaw Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Jefcare Sterile Medical Sheets and Molicare Premium Bed Mat in people with Incontinence-associated Dermatitis, run by Sir Run Run Shaw Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hongyang Hu (13858142984, 3193174@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.