Randomized comparison of a silicone tape and a paper tape for gentleness in healthy children.
OBJECTIVE
To compare the relative gentleness of a silicone tape to a paper tape in healthy infants and children.


METHODS
A randomized, grader-blinded, comparative study.


METHODS
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 × 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 μg/mL vs 15.2 ± 1.3 μg/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.
Gary L. Grove, PhD, Chief Scientific Officer, cyberDERM Clinical Studies, Broomall, Pennsylvania. Charles R. Zerweck, PhD, Director of Clinical Studies, cyberDERM Clinical Studies, Broomall, Pennsylvania. Bruce P. Ekholm, MS, Manager, Clinical Research, Critical and Chronic Care Solutions Division, St Paul, Minnesota. Graham E. Smith, BS, Biostatistician, Critical and Chronic Care Solutions Division, St Paul, Minnesota. Nancy I. Koski, BA, Clinical Research Specialist, Critical and Chronic Care Solutions Division, St Paul, Minnesota.
Gary L
GL
Grove
Charles R
CR
Zerweck
Bruce P
BP
Ekholm
Graham E
GE
Smith
Nancy I
NI
Koski
D000268:Adhesiveness; D001458:Bandages; D002675:Child, Preschool; D004867:Equipment Design; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008422:Materials Testing / Q000379:methods; D010209:Paper; D011312:Pressure; D012828:Silicones; D017592:Skin Care
D012828:Silicones