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Diaper Rash clinical trials

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NCT ID: NCT04101890 Terminated - Diaper Dermatitis Clinical Trials

The Healthy Baby Bottoms Study

Start date: March 12, 2020
Phase: Phase 4
Study type: Interventional

Diaper dermatitis is one of the most common dermatologic diseases affecting infants and children. The incidence is highest among those 9-12 months old and it has been reported to affect 7-50% of infants in the US. It is caused by skin exposure to a combination of several factors including: excessive moisture, topical irritants, reduced pH, friction, maceration and bacterial infection. When infants soil their diaper, diaper contents saturate the area raising the pH of the skin above the normal level of 5 or less, and leaving the area highly vulnerable to maceration from friction. Irritants in urine and feces are then able to penetrate the macerated skin, causing inflammation and greater skin friability. An elevation in the skin pH allows pathogenic bacteria to overgrow, and combined with the breakdown in the skin's outer epithelial barrier, can lead to bacterial infection. Theraworx Foam Formulation-Allantoin Liquid by Avadim Technologies, Inc. is a skin protectant with use for temporary protection of minor cuts, scrapes, burns and chapped or cracked skin. As such, Theraworx Foam used in the diaper area may be beneficial for protecting skin against diaper rash wounds, as well as for assisting with wound healing and reducing any associated pain. The purpose of this study is to determine caregivers' perceptions of the benefits of using Theraworx Foam on their infant's diaper area as part of their hygienic routine, including whether they feel the product is pleasant and easy to use, and whether they feel it helps prevent and reduce the severity of diaper dermatitis in their infants 1-14 months old.

NCT ID: NCT03685929 Completed - Pressure Ulcer Clinical Trials

Histopathological Comparison Between Superficial Pressure Ulcers and Incontinence-associated Dermatitis

Start date: October 1, 2018
Phase:
Study type: Observational

This study aims to identify differences and similarities between superficial pressure ulcers (category II and III) and incontinence-associated dermatitis (category IIA) at tissue level. Skin biopsies will be obtained from 30 patients with pressure ulcers (n = 10), incontinence-associated dermatitis (n = 10), and combined lesions (n = 10). The results from the histopathologic examination will be compared with the clinical diagnosis by wound care experts, which will be based on photographs and relevant patients' characteristics.

NCT ID: NCT03640897 Completed - Diaper Rash Clinical Trials

Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash

Start date: August 2, 2018
Phase: N/A
Study type: Interventional

Result of immaturity of the skin and factors promoting maceration and mechanical interactions, Irritant diaper dermatitis (IDD) can manifest as early as the third week of life. IDD is a form of contact dermatitis and is the most common inflammatory dermatitis of the diaper area infants. This dermatitis is very common amongst first year of life. The IDD is characterized by erythema on the convex surfaces with the skin folds spared (W-shaped erythema) and it can cause considerable pain and stress for infants and can be troublesome for their caregivers. The development of IDD is multifactorial. The critical step in the development of IDD is the occlusion of the skin under the diaper. The skin in the diaper area is predisposed to irritation by the presence of urine, stool, friction on the skin and presence of a high skin pH (potential Hydrogen). At the cellular level, there is a gradual disorganization of the lipid layers and later an attack of keratinocytes. Clinically, maceration is followed by an inflammatory reaction. Hence, infrequent diaper changes create overhydration and maceration of the stratum corneum, which makes the skin more sensitive to friction; this may interfere with the protective barrier function, allowing for the exposure of the lower layers to irritants (mechanical, chemical and infectious). The removal of maceration and the reduction of friction are the key to prevention. But it is recommended to respect preventive measures, in order to preserve the normal skin condition over the long term. Special care procedures are required to ensure healthy development and to protect the skin from irritation and inflammation, as well as a sense of well-being. Although use of appropriately formulated cleansers and emollients can help maintain the epidermal skin barrier in the diaper region, good hygiene and adequate protection are necessary to prevent skin barrier breakdown, rash and infection. The prevention of IDD includes frequent diaper changing, parent education and cleaning. LiNiRASH is a monocentric, prospective, randomized, comparator controlled study conducted under paediatric control. 132 infants will be followed in this study for 4 weeks during which their parents will use a specific cleaning method: water and cotton pads or wipes or liniment. The objective of this study is to compare the performance and safety of this 3 cleaning methods on the prevention of infant diaper rash.

NCT ID: NCT03490045 Completed - Stress Clinical Trials

Intervention to Reduce Diaper Need and Increase Use of Pediatric Preventive Care

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Well-child care is the primary source of preventative health care for children. These visits provide an opportunity for physicians to assess an infant's biomedical health, development, and behavior, as well as help ensure timely immunizations, reduce the use of acute care services, and assess and family functioning. Yet, disparities in the utilization of pediatric care exist by race, ethnicity and income in the U.S., even despite high rates of overall access to primary care. Incentives have been proposed as one way to increase utilization of preventative care for mothers and children. Diapering is another important form of preventative health care that can be particularly difficult for low-income parents due the cost of diapers, which is $70-80 per child per month, or approximately $960 per year, on average. And government programs, such as Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), Supplemental Nutrition Assistance Program (SNAP), and Temporary Assistance for Needy Families (TANF), either cannot be used to purchase diapers, or do not provide enough assistance to cover the cost of diapers and other basic needs. A family's inability to provide an adequate supply of diapers for their child is called diaper need. Nationwide, one in three families with young children report experiencing diaper need, which was found to be significantly associated with maternal stress and depression, which in turn, can have a detrimental impact on a family's health and economic success. The primary goal of this study is to conduct a randomized controlled trial of a diaper provision intervention designed to increase utilization of, and adherence to, well-child visits and reduce diaper need among low-resourced families in New Haven, CT.

NCT ID: NCT03425851 Withdrawn - Stress Clinical Trials

Diaper Distribution in Low-Income Infants

Start date: March 14, 2018
Phase: N/A
Study type: Interventional

The adverse effects of poverty at the individual, family, and community level on health outcomes for children are well-established. Material hardship, defined as difficulty meeting basic needs such as food, housing, and consumer goods, has been shown to have negative physical and emotional effects on both children and their parents. Diaper need, defined as a lack of sufficient supply of clean and dry diapers, is an example of a material hardship. Community-based studies of low-income families have demonstrated that between 30-50% of caregivers of young children expressed diaper need. Some of these caregivers with diaper need reported reducing diaper changes, a practice that is associated with diaper dermatitis and urinary tract infections (UTIs). These community-based studies have also shown that diaper need is associated with maternal depression and parental stress, even after adjusting for demographic factors and food insecurity. Diaper need may be a specific modifiable marker of caregiver stress and depression, beyond its role as an indicator of poverty. In this pilot, randomized controlled trial of low-income newborns and their caregivers the investigators will test the feasibility of supplying diapers as an intervention to infants in low-income families and assess if it can improve both a child's health and their caregiver's overall health.

NCT ID: NCT03309059 Completed - Diaper Rash Clinical Trials

Comparison of Barrier Products in the Prevention of Incontinence-associated Dermatitis in Hospitalized Elderly

Start date: May 2016
Phase: N/A
Study type: Interventional

In clinical practice, there are a large number of patients hospitalized with Incontinence-Associated Dermatitis. Studies are needed to determine the effectiveness of products available for disease prevention. It is believed that the use of the non-irritant barrier film is superior to the use of zinc oxide in the prevention of Incontinence-Associated Dermatitis. The objective of this study is to compare the effect of the use of zinc oxide ointment with the use of non-irritant barrier film in the prevention of diaper dermatitis in incontinent patients admitted to medical clinic units.

NCT ID: NCT03138057 Completed - Diaper Rash Clinical Trials

BM Characterization Pilot

Start date: May 1, 2017
Phase: N/A
Study type: Observational

This is a prospective, pilot study to explore the relationship between an infant's nutrition, skin and stool composition at different ages.

NCT ID: NCT02996357 Completed - Diaper Rash Clinical Trials

Risk Factors for Incontinence-Associated Dermatitis (IAD) in ICU Patients Suffering From Fecal Incontinence

Start date: October 4, 2016
Phase: N/A
Study type: Observational

This study aims to identify patient characteristics associated with the development of Incontinence-Associated Dermatitis (IAD) category 2 (skin erosion due to incontinence). 380 ICU patients suffering of fecal incontinence will be included in the study. Data on 19 possible risk factors will be collected at one point in time by the research team. Different sources and methods will be used to collect patient data: skin assessment, patient record, direct patient observation, routine blood samples.

NCT ID: NCT02893501 Completed - Diaper Rash Clinical Trials

Infant Microbiome in Diaper Rash

Start date: September 2016
Phase: N/A
Study type: Observational

The objective of this study is to evaluate the microbiome composition of infant's (9-12 month) skin experiencing diaper rash in order to determine if the onset and severity of erythema associated with diaper rash is influenced by the type of bacteria colonizing the skin.

NCT ID: NCT02716415 Completed - Diaper Dermatitis Clinical Trials

Trial Comparing Calmoseptine Ointment and Desitin Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants

Start date: March 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of Calmoseptine Ointment and Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in the treatment of diaper dermatitis among Neonates and Infants.