Prevention of Incontinence-associated Dermatitis and Maintenance of Local Skin Microclimate
NCT Number: NCT06509932
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Incontinence-associated Dermatitis
Interventions: DEVICE: Jefcare Sterile Medical Sheets|DEVICE: MoliCare Premium Bed Mats
Sponsor: Sir Run Run Shaw Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-01
Completion Date: 2024-10-10
Locations: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310016, China

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.

Primary Outcome Measures: 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 Outcome Measures: The time of IAD occurrence, Time to IAD after enrolment, 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., 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: 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., 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., Date of faecal incontinence (ICU admission to end of study) = total number of days of fecal incontinence after ICU admission.

Date of faecal incontinence (ICU admission to end of study) = Total number of fecal incontinence episodes after ICU admission/total number of days of fecal incontinence after ICU admission.

Average number of medical sheets used per day = total number of medical sheets used/time of intervention., 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 plate 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 plate after sampling., Total 2 times. 1 prior to intervention, 1 on occurrence of IAD or end of study i.e. day 5 of the intervention.