Muresan Mircea, Muresan Simona, Brinzaniuc Klara, Sala Daniela, Neagoe Radu
University of Medicine and Pharmacy of Tîrgu Mureș, Târgu Mureş, Romania.
Wounds. 2018 Sep;30(9):310-316. Epub 2018 Jun 25.
A new skin protectant with improved adhesion to denuded skin and resistance to wash off has been developed to protect skin from incontinence-associated dermatitis (IAD) or general loss of skin integrity.
This controlled, randomized, prospective, open-label study determines the durability of the new protectant when applied to intact skin in 21 healthy human volunteers and compares it to 3 other products used for similar clinical indications.
Eight 0.75-in circles of black carbon pigment were applied to the bilateral forearms (4 per arm to allow for duplicates) of the participants and covered with the various products. Participants conducted normal routine activities over 7 days. Photographs were taken and a test site assessment was completed before and after application of the products on day 0 and at days 1, 2, 3, 4, and 7 to evaluate pigment loss over time. Carbon integrated optical density (CIOD) was measured under the assumption that a loss of pigment correlated with a loss of the protective product. These data were used to calculate the percent barrier remaining over time.
The percent of intact film was significantly greater (P < .05) from day 3 onwards for the new skin protectant compared with the other 3 products. The new product showed no significant change in CIOD (P = .46) from day 1 through day 7, indicating no meaningful wear over time. The other 3 products showed significant changes in CIOD (P < .01) beginning at either day 2 or day 3.
The new skin protectant was more durable than the other products tested. It remained in place for up to 7 days for all participants, whereas the other products had < 50% remaining on the skin by that time point.
已研发出一种新型皮肤保护剂，其对裸露皮肤的粘附性增强且耐冲洗，可保护皮肤免受失禁相关性皮炎（IAD）或皮肤完整性普遍丧失的影响。
这项对照、随机、前瞻性、开放标签研究确定了这种新型保护剂应用于21名健康人类志愿者完整皮肤时的持久性，并将其与用于类似临床适应症的其他3种产品进行比较。
在参与者的双侧前臂（每侧4个，以便进行重复测试）上涂抹8个直径0.75英寸的黑色碳颜料圆圈，并用各种产品覆盖。参与者在7天内进行正常日常活动。在第0天以及第1、2、3、4和7天涂抹产品前后拍摄照片并完成测试部位评估，以评估随时间的色素损失。在假定色素损失与保护产品损失相关的情况下测量碳积分光密度（CIOD）。这些数据用于计算随时间剩余的屏障百分比。
从第3天起，新型皮肤保护剂的完整薄膜百分比与其他3种产品相比显著更高（P <.05）。新产品从第1天到第7天CIOD无显著变化（P =.46），表明随时间无明显磨损。其他3种产品从第2天或第3天开始CIOD有显著变化（P <.01）。
新型皮肤保护剂比其他测试产品更耐用。所有参与者的保护剂在皮肤上保留长达7天，而其他产品在该时间点皮肤残留量不到50%。
