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.

Continuous topical administration of a petrolatum formulation by a novel disposable diaper. 1. Effect on skin surface microtopography.

BACKGROUND: Cutaneous problems are commonly associated with the use of diapers. Aiming to help reduce them, we have explored the use of the inner layer of diapers as a means to deliver to the skin dermatological formulations intended to help protect it from overhydration and irritation. OBJECTIVE: To determine the feasibility of using the inner layer of the diaper as a vehicle for topical delivery of a petrolatum-based formulation and to determine its impact on skin surface microtopography. METHODS: Two independent, blinded, randomized clinical trials were conducted, on children 16-24 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 transfer of formulation to the skin and skin surface microtopography. RESULTS: During normal diaper use, formulation transfer from the diaper to the skin occurred in a cumulative, time-dependent manner and use of the formulation-treated diaper was associated with significant reductions in skin surface roughness compared to the control diaper. CONCLUSIONS: The results demonstrated the feasibility and skin surface benefits associated with continuous topical administration of a petrolatum-based formulation by this novel diaper. This unprecedented dosimetric approach offers new avenues to reduce further the dermatological problems commonly associated with diaper use.

Skin disorders and moisture in incontinent nursing home residents: intervention implications.

OBJECTIVE: To provide data needed to design an intervention trial to prevent or treat skin disorders in a high risk, incontinent nursing home population. DESIGN: The incidence and prevalence of nine common skin disorders were measured prospectively over a 60-day period using trained observers. Urinary and fecal incontinence frequency were measured over 24 hours, and mobility was measured with subjects both in and out of bed. Direct measures of skin moisture were taken with an impedance device in the presence and absence of urinary incontinence. Multiple regression analyses were used to relate the incontinence and mobility variables to the presence and development of skin disorders. SETTING: Four nursing homes. PARTICIPANTS: One hundred incontinent nursing home residents. MAIN OUTCOME MEASURES: Prospective measures of nine common skin disorders and skin moisture in four perineal regions under continent and incontinent conditions. RESULTS: All subjects had at least one skin condition identified during the 60-day data collection period. The most commonly observed skin condition was blanchable erythema, which occurred in 94% of the subjects, predominantly in the front and back regions that were closest to the urethra and rectum. Twenty-one percent of residents developed either a Stage 1 (nonblanchable erythema) or 2 pressure ulcer. All skin conditions were transient when measured every 3 weeks with the exception of blanchable erythema, which showed stability. Stage 3 or greater pressure ulcers and edema were not observed, and interrater reliability for the measure of papules was poor. Measures of urinary and fecal incontinence severity were correlated with blanchable erythema severity, and blanchable erythema and low bed mobility were predictive of pressure ulcer severity. Blanchable erythema severity was also predictive of Stage 1 and 2 pressure ulcers. Skin moisture levels in the back perineal farthest from the rectum (peripheral) were affected most by urinary incontinence. CONCLUSION: A trial to detect a 50% preventive effect on Stage 1 and 2 pressure ulcers would require that 167 subjects be monitored for 60 days. The transient nature of the skin effects require that skin be monitored at least once a week. Because blanchable erythema is so prevalent and appears to be associated with more severe skin conditions, it would make an excellent marker for beginning to assess the potential preventive effects of various interventions on the incidence of pressure ulcers and other related skin disorders in incontinent patients. It is likely that the back area peripheral to the urethra and rectum would experience the greatest benefit from an intervention trial to reduce moisture caused by incontinence.

A clinical method for testing the safety of catamenial pads.

Methods are described for assessing the gynecologic, dermatologic, and microbiologic effects of deodorant and non-deodorant catamenial pad use over a 6-month period. A controlled, randomized, investigator-blind parallel study was conducted with 190 women between the ages of 18 and 45 years. Data on medical histories, physical examinations, diagnostic laboratory tests, gynecologic and dermatologic examinations and microbiology were collected. No significant differences in gynecologic, dermatologic, or microbiologic parameters were observed between control and treated groups, and no pad-related adverse health effects were observed in this clinical study.

Association of skin wetness and pH with diaper dermatitis.

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.

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.