Comparison of the Effectiveness of New Material Diapers versus Standard Diapers for the Prevention of Diaper Rash in Chinese Babies: A Double-Blinded, Randomized, Controlled, Cross-Over Study

BACKGROUND: Diaper rash, also known as diaper dermatitis (DD), is a very common skin condition in infants, and use of disposable diapers with breathable materials is an effective approach for the management of diaper rash. In China, new material diapers and standard diapers are currently the two most commonly used disposable diapers. This study aimed to compare the effectiveness of new material diapers versus standard diaper for the prevention of diaper rash in Chinese babies. METHODS: A total of 80 eligible babies admitted to Shanghai Skin Diseases Hospital during the period from June through July, 2016, were enrolled and randomized into two groups. Babies in Group A (n = 41) used the new material diapers, and babies in Group B (n = 39) used standard diapers. Two weeks after the use of the diaper, the babies used the alternate product for the next 2 weeks. Skin conditions were assessed on the front and back waist, right and left buttock, pubic region, anal region, and right and left groin using a 6-point scoring system based on four parameters in 0, 2, and 4 weeks after use of the diapers. RESULTS: There were changes of the mean skin assessment score in each of the six regions after the use of the diapers. There were significant differences, in the mean skin assessment score of the front waist in Group A between weeks 2 and 4 (P = 0.006) and in Group B between weeks 0 and 2 (P = 0.004), and no significant differences were detected in the mean skin assessment score of the back waist and buttock in both Group A and Group B on weeks 0, 2, and 4. A higher mean skin assessment score of the pubic region was assessed in Group A on week 4 than on week 2 (P = 0.036), with a higher score seen on week 2 than on week 0 (P = 0.048), while no significant differences were found in Group B among weeks 0, 2, or 4. There was a higher mean score of the anal region assessed in Group A on week 2 than on week 0 (P = 0.01), while a higher mean score was found in Group B on week 2 than on weeks 0 (P = 0.036) and 4 (P = 0.01). In addition, a higher mean skin assessment score of the groin was detected on week 2 than on week 0 in both Group A (P = 0.00001) and Group B (P = 0.0001). CONCLUSION: The new material diaper is superior to the standard diaper for the prevention of diaper rash in Chinese babies.