Grove Gary L, Zerweck Charles R, Ekholm Bruce P, Smith Graham E, Koski Nancy I
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.
J Wound Ostomy Continence Nurs. 2014 Jan-Feb;41(1):40-8. doi: 10.1097/01.WON.0000436669.79024.b0.
To compare the relative gentleness of a silicone tape to a paper tape in healthy infants and children.
A randomized, grader-blinded, comparative study.
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.
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.
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).
Gentleness assessments favored the silicone tape compared to a paper tape and warrant further clinical investigation in the neonatal intensive care unit.
比较硅胶胶带与纸质胶带对健康婴幼儿的相对温和程度。
一项随机、分级者盲法的对照研究。
样本组包括24名9.1至46.7个月大的健康婴幼儿（平均±标准误，34.0±2.21）。该研究在宾夕法尼亚州布鲁莫尔的一家皮肤病研究机构（网络皮肤公司）进行。所有志愿者均从周边社区招募。
将尺寸为1×1.5英寸的胶带随机贴于上背部左右肩胛间区域。24小时后以标准化方式取下胶带。主要研究结果，即温和程度，基于对皮肤损伤、不适的视觉评估以及对角蛋白去除量的量化。使用四分制量表评估皮肤损伤，使用10分制的面部、腿部、活动、哭闹和安抚度工具评估不适。次要评估包括毛发去除、胶带边缘翘起评估以及家长对两种胶带的偏好。
硅胶胶带的平均±标准误红斑反应（0.93±0.14 vs 1.35±0.11，P = 0.0129）显著低于纸质胶带。与纸质胶带平均±标准误为0.29±0.11的反应相比，硅胶胶带未出现可测量的表皮剥脱（P = 0.0039）。与纸质胶带相比，硅胶胶带的不适程度显著更低（P = 0.0002）（面部、腿部、活动、哭闹和安抚度评分与基线的平均差值为0.5对3.3，P = 0.0002）。与纸质胶带相比，硅胶胶带对角蛋白的去除显著更少（8.7±0.5μg/mL对15.2±1.3μg/mL，P < 0.0001）。两种胶带去除的毛发都很少。纸质胶带的边缘翘起显著少于硅胶胶带（P < 0.0001）；在家长对硅胶胶带与纸质胶带的偏好方面未测得统计学显著差异（P = 0.3359）。
与纸质胶带相比，温和程度评估更倾向于硅胶胶带，值得在新生儿重症监护病房进行进一步的临床研究。
