Abstract
PURPOSE: To compare the relative gentleness of a silicone tape to a paper tape in healthy infants and children.
DESIGN: A randomized, grader-blinded, comparative study.
SUBJECTS AND SETTING: The sample group comprised 24 healthy infants and children 9.1 to 46.7 months of age (mean +/- SEM, 34.0 +/- 2.21). The study was conducted at a dermatological research facility (cyberDERM, Inc) located in Broomall, Pennsylvania. All volunteers were recruited from the surrounding community.
METHODS: Tapes measuring 1 x 1.5 inches were randomly applied to the left and right intrascapular regions of the upper back. Tapes were removed in a standardized fashion after 24 hours. The primary study outcome, gentleness, was based on visual assessments of skin damage, discomfort, and quantification of keratin removal. Four-point scales were used to assess skin damage, and a 10-point Faces, Legs, Activity, Cry, and Consolability instrument was used to assess discomfort. Secondary assessments included hair removal, tape edge-lift assessments, and parent preference for either tape.
RESULTS: There was a significantly lower mean +/- SEM erythema response for the silicone tape (0.93 +/- 0.14 vs 1.35 +/- 0.11, P = .0129) than for the paper tape. No measurable epidermal stripping occurred with the silicone tape compared to a mean +/- SEM response of 0.29 +/- 0.11 for the paper tape (P = .0039). Discomfort was significantly lower (P = .0002) for the silicone tape as compared to the paper tape (Faces, Legs, Activity, Cry, and Consolability score mean difference from baseline 0.5 vs 3.3, P = .0002). Keratin removal was significantly less with the silicone as compared to paper tape (8.7 +/- 0.5 [mu]g/mL vs 15.2 +/- 1.3 [mu]g/mL, P < .0001). Few hairs were removed with either tape. There was significantly less (P < .0001) edge-lift with the paper tape than the silicone tape; no statistically significant differences in parent preferences for silicone versus paper tapes were measured (P = .3359).
CONCLUSIONS: Gentleness assessments favored the silicone tape compared to a paper tape and warrant further clinical investigation in the neonatal intensive care unit.