Clinical studies with disposable diapers containing absorbent gelling materials: evaluation of effects on infant skin condition

Disposable infant diapers with absorbent gelling material (cross-linked sodium polyacrylates) incorporated into the core were clinically evaluated for their effect on infant skin condition. Absorbent gelling materials tightly hold water and provide pH control by a buffering capacity as well as by helping to segregate urine apart from feces. Four clinical studies were conducted with each following a rigid protocol that controlled for variables of diet and age in addition to the diaper material that may influence the development of diaper dermatitis and helped to control for any inherent bias in the study. This allowed for the controlled assessment of skin condition with respect to diaper type. Absorbent gelling material-containing disposable, conventional (100% cellulose core) disposable, and home-laundered cloth diapers were test products. In these studies 1614 infants were initially enrolled with 522 of them assigned to absorbent gelling material disposable, 738 to conventional disposable, and 354 to home-laundered cloth diapers. Objective measurements of skin wetness (transepidermal water loss) and skin pH, as well as double-blind grading of diaper dermatitis, were the measures of skin condition. Absorbent gelling material disposable diapers were associated with significantly reduced skin wetness, closer to normal skin pH, and lower degrees of diaper dermatitis when compared to conventional disposable or home-laundered cloth diapers. The results are consistent with the hypothesis that better control in the diaper area of skin wetness, skin pH, and the prevention of the mixing of urine and feces produces a better diaper environment.     

Clinical effects of diaper types on the skin of normal infants and infants with atopic dermatitis

Cloth diapers, cellulose core diapers (conventional disposable diapers), and cellulose core diapers containing absorbent gelling material were examined for their effects on diaper rash and skin microbiology of normal infants and infants with atopic dermatitis in a 26-week double-blind clinical trial. Infants with atopic dermatitis wearing the diapers containing absorbent gelling material had significantly lower diaper rash grades than infants with atopic dermatitis wearing cloth diapers at five of eight grading visits. Infants with atopic dermatitis wearing conventional cellulose core diapers had statistically less rash at one of eight visits. There was no statistically significant difference between diaper types at three of the eight visits. At no time did the cloth group have less diaper rash than the conventional cellulose or absorbent gelling material disposable diaper group. A statistical correlation between the severity of general atopic dermatitis outside the diaper area and the diaper rash condition under the diaper occurred only in the atopic dermatitis group wearing cloth diapers. Isolation of microorganisms from the intact, uninvolved skin surface both inside and outside the diaper showed no biologically significant changes in the presence or numbers of selected skin organisms. Repeated isolation, at multiple grading visits of Staphylococcus aureus from uncompromised skin inside the diaper area was infrequent but correlated with the diagnosis of atopic dermatitis when observed.     

Bullous diaper dermatitis with cloth diaper use

Irritant diaper dermatitis occurs at a higher frequency with cloth diaper use than disposable diapers. We present four cases of vesiculobullous, erosive diaper dermatitis occurring in older infants and toddlers with cloth diaper use that resolved completely after transitioning to disposable diapers. This is the first report of vesicles and bullae as a type of irritant diaper dermatitis.     

The Effects of Wearing Diapers on Skin

Wearing dry and wet cloth and disposable diaper materials has certain effects on the degree of skin wetness. These, in turn, affect the coefficient of skin friction, the skin's susceptibility to abrasion damage, its permeability, and its support of microbial growth. These effects were explored using an adult model wearing forearm patches. The adult model was validated by comparisons of skin wetness and friction values for infants and adults determined under similar conditions. Skin wetness was proportional to diaper wetness. With increased skin wetness, there were increased coefficients of friction and increased abrasion damage, skin permeability, and microbial growth. Cloth diaper material produced wetter skin than did disposable diaper material at equivalent loadings.     

Effects of Diaper Types on Diaper Dermatitis Associated with Diarrhea and Antibiotic Use in Children in Day-Care Centers

Infants and toddlers in day-care centers have a relatively high frequency of diarrhea and/or oral antibiotic use, and may be at increased risk of developing diaper dermatitis when diapered. A six-month, prospective, double-blind study was conducted in day-care centers in Houston, Texas, to determine the frequency of diarrhea, antibiotic use, and diaper dermatitis in infants and toddlers wearing conventional (cellulose-only core) disposable diapers or disposable diapers with a core of absorbent gelling material (AGM) and cellulose. A questionnaire was administered weekly to the day-care staff to gather health information, and weekly visual examinations were made of children for diaper dermatitis. The frequency of diarrhea was 1.9 episodes per child-year and that of antibiotic use was 3.3 courses per child-year. Infants diapered in disposable diapers with AGM had a significantly (P 0.032) lower mean grade of diaper dermatitis during diarrhea episodes and a lower (P 0.054) mean grade during antibiotic use, compared to those diapered in conventional disposable diapers. There was no significant difference between groups with regard to isolation of Staphylococcus aureus or Candida albicans from superficial skin cultures of the diapered area. The results indicate that diarrhea and antibiotic use occur frequently in children in day-care centers, and that the severity of diaper dermatitis is less in children wearing AGM disposable diapers than those wearing conventional disposable diapers in that setting.     

Diaper Dermatitis

Eruptions in the diaper area are the most common dermatologic problem in infancy. Such eruptions can be subdivided into primary diaper dermatitis, an acute inflammation of the skin in the diaper area with an ill-defined and multifactorial etiology, and secondary diaper dermatitis, a term which encompasses eruptions in the diaper area with defined etiologies. The most important factors in the development of primary diaper dermatitis are: (i) water/moisture, (ii) friction, (iii) urine, (iv) feces, and (v) microorganisms (sometimes). Possible treatments include minimizing diaper use and using disposable diapers, barrier creams, mild topical cortisones, and antifungal agents. A variety of other inflammatory and infectious processes can occur in the diaper area and an awareness of these secondary types of diaper dermatitis aids in the accurate diagnosis and treatment of patients.     

Association of Skin Wetness and pH With Diaper Dermatitis

Abstract: The strength of the association between diaper dermatitis and measurements of skin wetness and skin pH was evaluated by statistical analysis of four diaper trials involving 1601 infants. Although the strength of the association between skin wetness and diaper dermatitis was greater than that between skin pH and diaper dermatitis, increases in wetness and pH were both significantly associated with elevated mean grades for diaper dermatitis. The skin environment least likely to be associated with diaper dermatitis is one In which Increases In both skin wetness and skin pH are minimized.     

Frequency and severity of diaper dermatitis with use of traditional Chinese cloth diapers: observations in 3- to 9-month-old children

Chinese cloth diapers differ from disposable diapers in several respects that are central to our understanding of the etiology of diaper dermatitis (DD), yet there are no published reports on the dermatological correlates of this manner of infant care, which is prevalent among the world's second-largest pediatric population. The objective was to determine the prevalence and severity of DD in exclusive users of Chinese cloth diapers. This observational study was conducted during a single home visit to 694 Chinese children who were exclusive users of cloth diapers in five inland cities of China. During each home visit, study nurses documented the presence and severity of DD using a visual dermatological scale and conducted transepidermal water loss (TEWL) and pH measurements. Diaper dermatitis was rare in the buttocks and genital area of the children (<20%) but was common in the perianal and intertriginous regions (50-70%). TEWL and pH were mildly higher in babies with DD than in those without DD in the genital and buttocks area. Diaper dermatitis is common in children who use traditional Chinese cloth diapers, especially in the perianal and intertriginous regions.     

Diaper Dermatitis: Frequency and Severity Among a General Infant Population

The frequency and severity of diaper dermatitis was measured among a midwestern suburban population of 1089 infants ranging in age from 1 to 20 months. No diagnosis of specific etiology was made. Fecal samples were collected and analyzed for Candida albicans, and information on family characteristics, infant diet, general health, history of rash, and diapering habits and practices was collected by questionnaire. The distribution of the severity of observed diaper rash can be described as a logarithmic-normal function, implying several multiplicative causative factors. Within the total severity range, there appear to be three subcategories of diaper rash, differing in some manner, perhaps reflecting different etiologies. The frequency of observed diaper rash was a function of the maturity of the infant, reaching a maximum around 9 to 12 months of age. The prevalence of severe rash correlated with the presence and level of fecal C. albicans. Infants diapered exclusively in disposable diapers showed less rash (P less than 0.001) than those diapered exclusively or sometimes in cloth diapers.     

Scrotal temperatures do not differ among young boys wearing disposable or reusable diapers

Background/aims: This study investigated the effect of specific, commonly used diaper types on scrotal temperatures in normal healthy, young boys. These included both modern disposable and reusable diapers as well as various types of protective outer coverings that are in common use in both North America and Europe Methods: Scrotal and skin surface temperatures were continuously monitored in healthy, young males using a computerized data-logging system based on temperature probes specifically designed for paediatric studies. These systems could be used either tethered to the PC or made completely portable depending upon the age and activity of the child being measured. Based on our results from several pilot studies, it became clear that the best way to determine if disposable and reusable diapers differ with regard to their impact on scrotal temperatures is to run these comparisons under controlled laboratory conditions where ‘diaper type’ was the primary variable. A 2-h time period was chosen to ensure that sufficient time had elapsed for thermal equilibrium to be established under the diapers. We also felt it necessary to study the impact of urination and simulated this condition over the last 15 min using standardized methods. In addition to the skin surface temperatures, we also measured the temperature of the tympanic membrane using an infrared thermometer as an estimate of ‘core’ temperature for each individual at various times during the session. Results and Conclusions: In this study, we have clearly shown that scrotal temperatures are the same whether the child is wearing disposable or reusable cloth diapers with a protective cover. The only situation in which scrotal temperatures were found to be lower is when the cloth diaper is used alone without a protective cover but this is not representative of how these products are actually used. We also found that on average scrotal temperatures are significantly lower than core for each diaper type. Occasionally, we did see individuals in which the maximal scrotal temperatures approached core temperatures but in every case the thermal sensors were soiled by a bowel movement. We also found that skin surface temperatures increased not only when covered by a diaper but also due to the thermal insulation provided by outer garments and blankets.     

Comparison of Disposable Diapers with Fluff Absorbent and Fluff Plus Absorbent Polymers: Effects on Skin Hydration, Skin pH, and Diaper Dermatitis

Diaper dermatitis results from the action of a number of physical and chemical factors on the skin. While its etiology is complex, there is agreement that prolonged contact between wet diapers and the skin leading to excessive hydration of the stratum corneum and reduced barrier function is a primary factor. Recent research also indicates that pH elevation resulting from ammonia production increases the probability of skin damage due to fecal enzyme activity. New diapers containing absorbent polymers blended with cellulose fluff in the absorbent core have been developed. The absorbent polymer binds fluids and controls pH in the diaper environment. To assess the effectiveness of these diapers, a clinical study was conducted with approximately 150 infants over 15 weeks, using fluff diapers and absorbent polymer diapers. The results clearly showed that the diapers with absorbent polymer provide a better skin environment than those with fluff only with respect to lower skin wetness and pH control (instrumental measurements). In addition, the clinicians' grades indicated a directional reduction in diaper rash severity.     

Effects of breathable disposable diapers: reduced prevalence of Candida and common diaper dermatitis

Infants wearing breathable disposable diapers experienced significantly less diaper dermatitis (DD) compared to infants wearing standard, nonbreathable disposable diapers in a series of double-blind clinical trials. Severe DD, including confirmed infection with Candida albicans, was reduced by 38-50% among infants wearing highly breathable (HB) diapers. The prevalence of DD was inversely related to the breathability of the garments. The inhibitory effect of breathable diapers on the survival of Candida was further confirmed in controlled experiments with adult volunteers. A suspension of C. albicans cells was applied to delineated sites on the volar forearm. Each site was then covered by a full-thickness patch from either an HB or a standard diaper. Survival of Candida colonies was reduced by almost two-thirds in the breathable diaper-covered sites compared to the control sites.     

Skin care of the diaper area

Abstract:  The skin of the diaper area has special needs for protection from the irritating effects of urine and feces and prevention of diaper dermatitis. These needs include products such as diapers that absorb the excreta, as well as products for cleansing and conditioning the skin. A number of factors play a role in development of diaper dermatitis, including prolonged exposure to excreta, alterations in skin pH or increased hydration, and changes in skin microbial flora. Recent decades have seen great improvements in our understanding of these factors and our ability to develop new and better products to protect baby skin. Better diaper designs and the development of pH-buffered baby wipes have improved the care of skin in the diaper area. Continuing research offers the promise of new products with additional benefits for caregivers and infants.     

Hydration vs. skin permeability to nicotinates in man

Background/aims: Prolonged skin occlusion increases stratum corneum water content and often increases skin permeability and irritant dermatitis. As skin wetness from wearing diapers is considered an important factor favouring the onset of diaper dermatitis, optimal diapering might decrease skin hyperhydration and dermatitis. Our aim is to define the quantitative relationship between nicotinate ester (a model penetrant) skin permeability and hydration, as measured by water evaporation rate (WER), decay curves (at individual time points) and WER-area under the curve (WER-AUC); and also to determine the level of skin hydration and skin permeability to nicotinates following a diapering simulation. Methods/results: Nine healthy Caucasian adult women were enrolled after a prescreening procedure (time to peak redness response to nicotinate); each received three wet occlusive patches for different exposure times (10 min, 30 min, and 3 h) and two wet model diapers (3 and 8 h). Prior to patching or diapering of forearms, basal values of WER, skin blood flow volume (BFV), capacitance (Cap) and redness (a*) were measured on premarked sites (a, b, c and d). Immediately, following occlusive patch or diaper removal, 20 µL of each nicotinate (methyl and hexyl nicotinate) was applied to its respective site (a or b). The WER and Cap readings were recorded at designated sites (c and d) with the following intervals after nicotinate applications: 0, 5, 10, 15 and 20 min. The a* and BFV measurements were made on each nicotinate challenged site (a and b) with the following intervals after nicotinate applications: 5, 10, 15, 20, 30, 40, and 60 min. Results: WER-AUC and thus, skin hyperhydration, increased with occlusive patch and diaper exposure time, but there was no statistical difference between 3 and 8 h diaper sites. All patched sites had significantly (P < 0.05) increased hydration in comparison to control sites (undiapered or unpatched skin). Cap increased with occlusion time with patches, but not with diapers. The degree and time-course of redness from nicotinates did not vary with extent of skin hydration, but was significantly increased compared to non-hydrated skin. BFV-AUC did not show a significant increase between diapers at 3 and 8 h sites; the BFV-AUC values varied on the patched sites, but some were significantly (P < 0.05) higher than control site. Conclusion: Wet patches and diapers increased skin hyperhydration proportional to exposure time. Permeation of nicotinates was increased for hydrated skin vs. control, even after only 10 min of patch exposure. For these model permeants, we found no evidence of increased permeation rates with increased hyperhydration, once a relatively low threshold of hyperhydration was achieved (e.g. that reached after a 10 min wet patch). The data showed no meaningful differences in permeation following either diapering simulation and also suggested that the WER-AUC method was superior to capacitance for measuring the absolute extent of hyperhydration. We believe this is a suitable model for evaluating the quality of diaper product performance, as well as in pharmacologic assays of occlusive therapy.     

Dye exclusion as a means to measure wetness protection of human skin

BACKGROUND/PURPOSE: Excessive skin hydration from occlusive coverings such as absorbent articles, bandages, etc. has been known to compromise the skin's barrier properties. Damage to the stratum corneum occurs from prolonged exposure to wetness and limited product breathability, which reduces evaporation. Protection from wetness may be imparted by barrier materials, such as lotions and ointments on the skin. Barrier materials are traditionally applied by hand from bulk containers (bottle or tube). In recent years, diapers have been made that contain barrier ointments designed to transfer to the skin during wear. The purpose of this research was to develop a reliable in vivo method for evaluating skin wetness protection when using personal products. METHOD: The means for evaluating wetness protection in vivo is dye exclusion evaluation on human skin. Dye exclusion involves application of a barrier material, followed by dye application and skin staining evaluation. The dye exclusion method may be conducted on adult forearms with direct application of the barrier material or on infant or adult torsos after wearing a diaper or incontinence product (or other personal products) that contains the barrier material. Dye exclusion on infants used cosmetic dyes (safe for use in the eye area). RESULTS: Dye exclusion demonstrated skin protection on both adult forearms and on infant buttocks. Ointments in diapers protected the skin from the dye when diapers were worn from a few hours to several days (with appropriate changes of product). CONCLUSION: The dye exclusion method was able to demonstrate the advantage of barrier ointments for wetness protection and also to discriminate between ointment formulations.     

Rosin components identified in diapers

As part of the investigation of sources of exposure of rosin allergens, disposable diapers (napkins) common on the Swedish market were analyzed, using gas chromatography, to detect the main rosin compounds. Rosin components were detected in all diapers, the highest amounts in those from the 2 major producers. In these diapers, more rosin was found in the top layer, which is in close contact with the skin, than in the fluff. Despite the possibly minimal risk of induction of sensitization to rosin allergens in diapers, there is a real risk of elicitation of dermatitis in sensitive individuals, especially since penetration is enhanced by occlusion and irritation. Such material is not only used for infant diapers, but also for adult incontinence products and feminine hygiene products.     

Skin interaction with absorbent hygiene products

Skin problems due to the use of absorbent hygiene products, such as diapers, incontinence pads, and feminine sanitary articles, are mostly due to climate or chafing discomfort. If these conditions are allowed to prevail, these may develop into an irritant contact dermatitis and eventually superficial skin infections. Skin humidity and aging skin are among the most significant predisposing and aggravating factors for dermatitis development. Improved product design features are believed to explain the decline in observed diaper dermatitis among infants. Where adult incontinence-related skin problems are concerned, it is very important to apply a holistic perspective to understand the influences due to the individual's incontinence level and skin condition, as well as the hygiene and skin care measures provided. Individuals with frail, sensitive skin or with skin diseases may preferably have to use high-quality products, equipped with superabsorbent polymers and water vapor-permeable back sheets, to minimize the risk of skin complications.     

Continuous topical administration of a petrolatum formulation by a novel disposable diaper. 2. Effect on skin condition

BACKGROUND: Diaper dermatitis is a common childhood affliction. Aiming to help reduce the prevalence of this problem, we have developed a novel diaper to deliver to the skin dermatological formulations intended to help protect the skin from overhydration and irritation. OBJECTIVE: To determine the clinical benefits of a novel disposable diaper designed to deliver a petrolatum-based formulation continuously to the skin during use. METHODS: Two independent, blinded, randomized clinical trials were conducted, involving an aggregate total of 391 children, 8-24 months of age. All comparisons were done versus a control diaper, identical to the test product except for the absence of the petrolatum formulation. The studies determined the effects of the novel diaper on skin erythema and diaper rash. RESULTS: Use of the formulation-treated diaper was associated with significant reductions in severity of erythema and diaper rash compared to the control product. CONCLUSIONS: The results demonstrated the clinical benefits associated with continuous topical administration of a petrolatum-based formulation by this novel diaper. We anticipate that this advance in diaper design will contribute significantly to further reduce the prevalence and severity of irritant contact dermatitis in the diaper area.     

Factors involved in the development of diaper‐area granuloma of the aged

An infant skin disease with clusters of nodules in the diaper contact area was reported as granuloma gluteale infantum. Recently, the number of elderly patients with this condition has increased, and it has been reported as diaper‐area granuloma of the aged. These lesions are presumably caused by irritation from feces and urine. We observed similar cutaneous symptoms in six elderly patients, five of whom revealed clusters of nodules arranged in a circular pattern in the gluteal region presenting a peculiar clinical picture. They were all bedridden and wore cloth diapers. We speculate that wearing a cloth diaper seems to be a major factor behind this condition. Another factor was sitting during the day. A subject had lesions with nodules on the scrotum. The distribution of nodules appeared to be related to the body position and vigorous movement of the patient. In all cases, topical steroid therapies were not effective. They were all positive for bacteriuria. Chronic urinary tract infection further irritates the skin. It is necessary to reduce urine contact and keep the lesion clean.     

Diaper dermatitis-frequency and contributory factors in hospital attending children

Abstract:  The incidence and prevalence of diaper dermatitis varies widely between published studies. It is a condition which causes considerable parental anxiety. To better understand the frequency of diaper dermatitis, treatment practices, and the current importance of previously identified etiologic factors, a questionnaire survey of parents who had children wearing diapers ( n  = 532) attending a large United Kingdom district general hospital was undertaken. At the time of survey, only 16% of the study population had diaper dermatitis. Forty-eight percent of the study population had never had an episode of diaper dermatitis. In a multivariate analysis, current diaper dermatitis was independently associated with four factors: presence of oral thrush, number of previous episodes, frequency of diaper changes, and diarrhea. Recurrent episodes of diaper dermatitis were associated with increasing age, lack of barrier cream use, current diaper rash, and frequency of diaper changes. In the majority of children with diaper dermatitis at the time of survey, treatment had been instituted in the community. Diaper dermatitis usually presents and is treated successfully outside the hospital setting and is not a common clinical problem in secondary care.