The Healthy Baby Bottoms Study
The Healthy Baby Bottoms Study
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.
Inclusion Criteria:

 -  Read English at the 8th grade level

 -  Have reliable access to email for 7 weeks

 -  Complete the first online survey within 24 hours of the request

 -  Custodial guardian of an infant between the ages of 1-12 months old living with
 him/her, wearing diapers, and has had ≥1 diaper rash in the 2 months preceding
 recruitment

 Exclusion Criteria:

 -  Does not have a stable address at which to receive a package of Theraworx and is
 unable/unwilling to pick it up at Children's National Health System

 -  Infant is immunocompromised, has a congenital disorder, or on the day of recruitment,
 has a diaper rash, has a moderate to severe illness requiring hospitalization or
 transfer to the emergency room, or was circumcised <10 days prior.