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Industry: Email Alert RSS FeedA laboratory-based study to assess the performance of surgical gloves
AORN Journal, April, 2003 by Denis M. Korniewicz, Maher M. El-Masri, John M. Broyles, Christopher D. Martin, Kevin P. O'Connell
Study protocol. Unstressed gloves were tested according to the flowchart in Figure 1. Gloves were taken directly out of the package and visually inspected for defects. If a visible defect was observed, the glove failed the test. If no visible defect was observed, the research assistant tested the glove using the FDA water leak protocol. Gloves were filled with 1,000 mL of water, suspended for two minutes, and observed for the presence of leaks. (16) If a glove did not leak water, the glove was determined to have passed the test.
[FIGURE 1 OMITTED]
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To mimic the stresses that surgical gloves undergo during clinical situations, gloves were stressed according to the flowchart shown in Figure 2. After removal from the package and after each step of the stress protocol, each glove was inspected visually. If a visible defect was observed, the glove failed the test. If no visible defects were observed after completion of steps one through eight, the glove wearer removed the glove and performed the FDA water leak test. If no water leak was observed, the glove was determined to have passed the test.
[FIGURE 2 OMITTED]
DATA ANALYSIS
All data analysis procedures were performed using SPSS--Statistical Package for the Social Sciences, version 10. (17) For the purpose of the analysis, data from the eight brands of gloves were recoded to reflect the four independent variables of interest:
* stress protocol,
* material,
* manufacturer, and
* presence or absence of glove powder.
The outcome variable was pass or fail determined either by the visual or water leak tests. General frequencies were performed to provide basic descriptive analysis of the study findings. Chi-square analysis was used to test the differences between the frequencies of failure across each of the study variables and to examine for possible confounding effects between pairs of these variables. Crude odds ratios were calculated to assess the effect of study variables on glove failure rates. Multivariate logistic regression analysis was used to calculate the adjusted odds ratio of failure rates. An [alpha] of 0.05 was established for statistical significance.
RESULTS
Table 1 presents basic descriptive statistics of glove failure rates according to material, brand, presence of glove powder, manufacturer, and stress. Nitrile gloves exhibited the lowest failure rate (1%), followed by latex (2.9%) and neoprene (3.1%). Isoprene gloves had the highest failure rate (16.3%). Failure rates among the four glove materials were found to be significantly different ([X.sup.2] = 191.15, P < .001); however, failure rates of latex gloves were significantly lower than those of the nonlatex gloves combined ([X.sup.2] = 7.005, P = .005). The analysis in Table 2 indicates that subjecting gloves to stress significantly increased their failure rates when compared to unstressed gloves (6.8% and 1.9% respectively, [X.sup.2] = 59.94, P < .001). Powdered gloves had significantly higher failure rates than nonpowdered gloves (6.7% and 3.1% respectively, [X.sup.2] = 28.74, P < .001). Failure rates were found to be significantly different among the six glove manufacturers included in the study ([X.sup.2] = 128.35, P < .001), with manufacturer (M) 5 having the lowest failure rate (0.4%) and M3 having the highest failure rate (7.5%).
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