Improving newborn skin health: Effects of diaper care regimens on skin pH and erythema.

BACKGROUND/OBJECTIVE: Newborn infant skin is functional but immature, and diapering products can play a significant role in infant diapered skin health. Previous work demonstrated a regimen consisting of a diaper with an emollient and apertures on the inner liner (topsheet) with an acidic, pH-buffered wipe (Regimen A) lowered newborn skin pH and reduced the enzymatic activity on skin post-stool cleaning versus a regimen without these features (Regimen B). This study extends these findings to determine the impact of Regimen A on diaper area erythema severity over a 2-week use period. METHODS: This IRB-approved, blinded, randomized, crossover study enrolled newborn infants >7 days and ≤8 weeks. Participants exclusively used two unique diaper and wipe combinations, Regimen A and Regimen B (non-emollient, non-aperture containing topsheet and wipe with limited buffering capacity), each for 14 days and preceded by a 3-day washout regimen. RESULTS: Diapered skin pH was reduced during Regimen A use to values similar to that of a non-diapered control site (chest), while use of Regimen B was associated with a more alkaline skin pH. Regimen A resulted in significantly fewer severe erythema episodes. At the site of highest erythema, the perianal space, the average erythema score was significantly lower and more newborns were free of erythema while using Regimen A vs. Regimen B (P < .05). CONCLUSIONS: These findings demonstrate that diapering products can have a significant impact on newborn skin. They reinforce the need to support the physiological normalization of skin pH and protection from skin irritation and damage.

Use of an emollient-containing diaper and pH-buffered wipe regimen restores skin pH and reduces residual enzymatic activity.

BACKGROUND/OBJECTIVES: Diaper dermatitis is one of the most frequent skin conditions affecting infants and is associated with elevated skin pH, exposure to urine and feces, and increased fecal protease and lipase activity, resulting in stratum corneum barrier damage and increased risk of infection. The study aim was to determine the impact of two diaper and wipe regimens on newborn infant skin pH and residual enzyme activity after stool cleaning. METHODS: Two diaper and wipe regimens were compared in a randomized, single-blinded crossover study. Regimen A paired an emollient-containing diaper with an acidic, pH-buffered wipe. Regimen B was a non-emollient diaper and wipe with limited buffering capacity. A 3-day washout period preceded each 3-day regimen use period. Skin pH at the perianal/buttocks interface (PBI), genital region, and undiapered chest control were measured at baseline and day 3. Skin swabs were collected for residual enzyme activity after a stool cleaning event. RESULTS: Diapered skin pH at the PBI was similar to undiapered skin after 3 days of use for Regimen A, while PBI pH for Regimen B was elevated versus control. PBI pH was lower for Regimen A versus Regimen B. After a stool cleaning, PBI skin pH for Regimen A was lower immediately and had lower residual enzyme activity versus Regimen B (P < .05), and the pH-lowering effect was sustained up to 60 minutes. CONCLUSIONS: These results suggest that the use of an emollient-containing diaper with a pH-buffered wipe creates conditions favorable to optimum diapered skin health.

Diaper dermatitis prevalence and severity: Global perspective on the impact of caregiver behavior.

OBJECTIVES: To compare prevalence and severity of diaper dermatitis (DD) in infants and toddlers (babies) across three countries (China, USA, and Germany), including diapered skin measures and caregiver practices. METHODS: A cross-sectional study of 1791 babies (~600 from each country) was recruited at each clinical site. Based on regional toilet-training habits, exclusively diaper-wearing infants were recruited between ages 2-8 months in China and 2-18 months in the USA and Germany. DD was measured, as well as skin pH, transepidermal water loss (TEWL), and relative humidity (RH) in the diapered region. Caregiver habits were collected via a questionnaire and included information on hygienic practices. RESULTS: Diaper dermatitis was highest in the perianal area, followed by the intertriginous, genital, and buttock regions. In general, DD was significantly lower in babies in China, highest in Germany, and intermediate in the USA. This rank ordering of DD by geography was also observed in baby age 2-8 months. The lower DD observed in China was associated with lower skin pH and TEWL on diapered skin and decreased RH in the diaper. Chinese caregivers had the highest rate of prophylactic topical product usage, the most robust cleaning of the diapered area, lack of cleansing after urine-only diaper changes, and Chinese infants spent the least time in an overnight diaper. CONCLUSIONS: These data suggest caregiver behaviors including prophylactic use of topical products, thorough cleaning after stooling and reduced time in an overnight diaper are associated with less DD, lower superficial skin pH, and enhanced skin barrier.

Dermatological testing of an improved apertured film surface for feminine hygiene pads.

CONTEXT: Apertured polyethylene films (AF) have been used as a surface for sanitary pads for decades because they are compatible with the skin and keep the pad surface drier. A modified film (AF-plus) with improved fluid handling and a smoother, suppler texture has been developed. We hypothesized that these changes would improve both performance and skin compatibility. However, distinguishing the skin effects of materials that are inherently mild is a challenge. OBJECTIVES: (i) To compare the skin irritation potential of pads with AF-plus modified film relative to the standard AF film and (ii) to assess the potential for the AF-plus film to induce delayed contact hypersensitivity. MATERIALS AND METHODS: Pads bearing the AF-plus film were compared to pads with the standard AF film in a behind-the-knee (BTK) test, which assesses the combination of chemical irritation and frictional effects of materials applied to the popliteal fossa under a semi-occlusive bandage. Erythema on the skin surface was scored with the naked eye and subsurface tissue erythema was visualized and scored using cross-polarized illumination. Skin dryness was scored with the naked eye only. One-sided statistical evaluations were performed to test the hypothesis of AF-plus film superiority. The potential of the AF-plus film to induce delayed contact hypersensitivity was assessed by a human repeat insult patch test (HRIPT). RESULTS: Pads with the AF-plus surface were significantly milder to skin in the BTK test, producing lower levels of both surface and subsurface tissue erythema. Moreover, subjects with preexisting erythema on the skin surface at study start developed comparatively less erythema over the course of the study overall with the AF-plus pad compared to the AF pad. No significant difference in skin dryness was observed between product groups. The AF-plus pad showed no evidence of inducing delayed contact hypersensitivity. CONCLUSIONS: The AF-plus pad was superior to the AF pad in terms of skin mildness as discerned by objectively scored surface and subsurface tissue erythema. In subjects with preexisting erythema, the AF-plus pad appeared to contribute less to the further development of inflammation under the test conditions. Given the compositional similarities in the two films, the results could point to more limited contribution of the AF-plus film to skin friction, one of the factors simulated by the BTK test protocol.

Improving Diaper Performance for Extremely Low-Birth-Weight Infants.

BACKGROUND: Extremely low-birth-weight (ELBW) infants face significant diapering challenges compared with their full-term peers, due to immature musculature, nervous system, and skin development. Advances in medical care have increased an ELBW infant's rate of survival, which creates a growing need for diapers to better serve these infants. Aim of research. The objective of this study was to identify and confirm the requirements for optimal diaper performance from the neonatal intensive care unit nurses' perspective, as well as to assess in-hospital performance to determine if new features improved key developmental care parameters. METHOD: Two surveys were shared among nurses to address study objectives. Study 1 (N = 151) was designed for neonatal intensive care unit nurses to identify key requirements for ELBW diapers and rate the performance of existing ELBW diapers. Study 2 (N = 99) assessed in-hospital performance of the test diaper compared with the usual diaper, under normal usage conditions. Findings/results. The majority of nurses agreed that ELBW diapers must fit appropriately between the legs so that hips and legs are not spread apart and that ELBW diapers need to be flexible between the legs for positioning. Of the nurses-infant pair responses, 93% ( P < .0001) preferred the test ELBW diaper over their usual diaper. CONCLUSION: Findings suggest that nurses should be included in the product design process to ensure both their needs and the needs of an infant are being met. Nurses are considering how diaper features may affect both acute and long-term medical outcomes and this information provides necessary guidance to diaper manufacturers and designers when developing better-performing diapers.

Induction of epidermal damage by tape stripping to evaluate skin mildness of cleansing regimens for the premature epidermal barrier.

BACKGROUND: Previous works indicate a compromised skin model may be a possible surrogate for premature, undeveloped skin. OBJECTIVES: This study was performed to investigate the use of a current model as a surrogate test design. METHODS: Serial tape stripping on the volar forearms of adult female volunteers (n = 36) was used to "thin" the stratum corneum. The forearm sites received intensive applications of different wiping options that exaggerated the exposures to cleansers that might be experienced by an infant in a neonatal intensive care unit. The recovery of skin barrier function during the wiping regimen, measured by transepidermal water loss (TEWL), was used as the primary indicator of the mildness of the cleansing options. Measurements of TEWL were made prior to the first wash on days 1-4, on day 5 and on day 8. Erythema was graded as a secondary endpoint. RESULTS: There was an early and sustained distinction in rates of skin barrier recovery between the washcloth and water treatment, and the two wipes treatments (P < 0.05). Areas submitted to the wipes treatments showed recovery rates similar to that of the tape-stripped untreated site, indicating that the use of disposable wipes led to minimal perturbation of the recovery process. By contrast, cleansing with a cotton washcloth and water markedly perturbed the repair process compared with all other conditions (P < 0.05). CONCLUSIONS: This model shows promise as a possible surrogate model for assessing the mildness of skin cleansing products for the care of premature infants.