Kiat-Amnuay Sudarat, Waters Patrick J, Roberts Dianna, Gettleman Lawrence
Department of Restorative Dentistry and Biomaterials, The University of Texas Dental Branch at Houston and M. D. Anderson Cancer Center, Houston, Tex., USA.
J Prosthet Dent. 2008 Jun;99(6):483-8. doi: 10.1016/S0022-3913(08)60113-4.
A key factor of a successful facial prosthesis is the retention of the prosthesis to the patient's skin, especially when there is no mechanical means and the retention depends primarily on medical skin adhesives. Studies determining which medical adhesives provide the best bond strength for maxillofacial prostheses are needed.
The purpose of this study was to quantify the force required to detach strips of Silastic Adhesive A/MDX4-4,210 silicone elastomer with a urethane liner (A/M-U) and experimental chlorinated polyethylene elastomer (CPE) from the skin of human subjects coated with a protective dressing using 1 of 2 medical adhesives.
With IRB approval, 8 A/M-U and CPE rubber strips (total of 208) were applied in a predetermined random order to the left and right ventral forearms of 26 human subjects. Skin-Prep Protective Dressing (SP) was applied to half of the sites just before Epithane-3 (E3) and Secure(2) Medical Adhesive (SMA) were used to adhere the strips. Strips were peeled 6 hours later in a universal testing machine at 10 cm/min. Data are reported in newton/meter (N/m). The data was compared using a 3-way, within-groups, multivariate analysis of variance (MANOVA) and the Fisher exact test (alpha=.05). Values for N/m under various conditions relating to the subjects were compared by the Tukey HSD Test for unequal N (alpha=.05). Data are reported as mean (SD).
Statistical analysis revealed no differences (mean (SD)) and no significant interactions between the independent variables (A/M-U = 94.6 (62.1) and CPE = 98.4 (69.6) N/m, SP = 93.0 (58.8) and no SP = 99.8 (72.1) N/m, E3 = 97.6 (69.8) and SMA = 95.3 (61.8) N/m; P=.984). Debonding occurred at the skin interface for both adhesives, as evidenced by residue on prosthetic materials (Fisher exact test; P<.005).
The adhesive bond strengths of both SMA and E3, with and without the presence of SP, were not significantly different between A/M-U and CPE maxillofacial prosthetic materials. Adhesive failure occurred at the skin interface.
成功的面部假体的一个关键因素是假体与患者皮肤的固位,尤其是在没有机械固位方式且固位主要依赖医用皮肤粘合剂的情况下。需要开展研究来确定哪种医用粘合剂能为颌面假体提供最佳的粘结强度。
本研究的目的是使用两种医用粘合剂中的一种,对涂有防护敷料的人体受试者皮肤,定量测定用氨基甲酸乙酯衬里的硅橡胶粘合剂A/MDX4-4,210(A/M-U)条带和实验性氯化聚乙烯弹性体(CPE)条带分离所需的力。
经机构审查委员会批准,将8条A/M-U和CPE橡胶条带(共208条)按预定随机顺序贴于26名人体受试者的左右前臂腹侧。在使用Epithane-3(E3)和Secure(2)医用粘合剂(SMA)粘贴条带之前,对一半部位涂抹Skin-Prep防护敷料(SP)。6小时后在万能试验机上以10厘米/分钟的速度剥离条带。数据以牛顿/米(N/m)为单位报告。使用三因素组内多元方差分析(MANOVA)和Fisher精确检验(α = 0.05)对数据进行比较。通过Tukey HSD检验(α = 0.05)对与受试者相关的各种条件下的N/m值进行比较。数据报告为平均值(标准差)。
统计分析显示,自变量之间无差异(平均值(标准差))且无显著交互作用(A/M-U = 94.6(62.1)N/m,CPE = 98.4(69.6)N/m;SP = 93.0(58.8)N/m,无SP = 99.8(72.1)N/m;E3 = 97.6(69.8)N/m,SMA = 95.3(61.8)N/m;P = 0.984)。两种粘合剂在皮肤界面均发生脱粘,这在假体材料上的残留物中得到证实(Fisher精确检验;P < 0.005)。
在有或没有SP的情况下,SMA和E3对A/M-U和CPE颌面假体材料的粘结强度均无显著差异。粘合剂失效发生在皮肤界面。