Materials & methods: Power analysis from a pilot trial specified 30 subjects. Eight Silastic Adhesive A/MDX4-4210 (Dow-Corning) strips were applied in a predetermined random order to the left and right ventral arms of 30 IRB-approved human subjects who washed with Dial® deodorant soap. Skin PrepTM (Smith+Nephew) was applied. Secure2 Medical Adhesive (SMA) (Factor II) and Epithane-3 (E3) (Daro) were used to adhere strips alone, or as SMA/E3 or E3/SMA sandwiches (from skin to prosthesis) and covered by long sleeves in the winter. They were peeled 6 hours later in an Instron at 10 cm/min.
Using SPSS, paired t-tests checked left-right arm differences. A multivariate repeated-measures ANOVA with within-subject design was performed between both adhesives and both application methods.
Results: Tests of left-right differences were insignificant (p=0.43), so the data from both were combined. Many strips with E3 on the skin fell off before testing and counted as zero adhesion. Mean peel strength in N/m (±SE) were: SMA- 77.4 (6.23); E3- 13.9 (6.68); SMA/E3 105 (3.42); and E3/SMA- 27.9 (5.18). Adhesives were significantly different (p<0.0005) and application methods also differed (p<0.0005), with no interaction between adhesives and application methods (p=0.067).
Conclusions: Multiadhesive SMA (skin)/E3 (prosthesis) was 27.6% stronger than SMA alone, and much stronger than E3 or E3/SMA, both of which left a difficult-to-remove residue on the skin; SMA/E3 left a residue at the periphery.
Support: UofL Vice President for Research, with help from J.P. Scheetz. Products from Factor II, and Smith+Nephew.