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INTRODUCTION
With the increase in the use of rubber gloves, allergic reactions to latex have been reported more and
more frequently since the rst described case in 1979
(Nutter, 1979). High risk groups who are hypersensitive to latex proteins include not only the health
personnel in operating rooms, but also the patients
with certain conditions, such as children with spina
bida and patients who have undergone multiple
surgical procedures (Moneret-Vautrin et al., 1993;
Kelly et al., 1994; Woods et al., 1997). Other risk
groups have also been reported to include persons
with atopy, patients with congenital urinary tract
anomalies, individuals with chronic exposure to
rubber products, and patients with cross-sensitization (Moneret-Vautrin et al., 1993; Charous et al.,
Received 19 October 1998; in nal form 6 February 1999.
$Author to whom correspondence should be addressed.
Tel.: +886-4-723-8595; Fax: +886-4-723-6932.
275
A randomized trial was conducted to evaluate the quality of four dierent brands of surgical
gloves in terms of the perforation rate, ventilation, tness, allergic reaction, elasticity,
thickness, powder, and satisfaction. Gloves of four dierent manufactures which were used by
various medical centres were distributed to participants according to a computer-generated
randomization table. A structured questionnaire was self-administered by volunteers
immediately after the surgical procedure to gather the information from participants, including
the demographic data, allergy history, length of use, and variables of quality measures. Two
brands, A and D, were signicantly inferior to the best manufacture among the four, B, in
terms of the ventilation, elasticity, and thickness, odds ratios ranging from 6 to 24, p < 0.05.
For the amount of corn starch powder and satisfaction, all three other brands were inferior to
brand B, odds ratios ranging from 6 to 44, p < 0.05. Gloves worn longer than 2 hours had a
slightly higher perforation rate post procedures (11.5% vs. 2.1%, p=0.048). The rate of latex
allergic reaction was not signicantly dierent between surgeons (8.3%) and the others (6.7%).
No dierence of the allergic reaction rate was found between subjects with allergy history
(7.7%) and those without the history (7.5%). The quality of surgical gloves diers from brand
to brand. The government and institutions should take the responsibility of monitoring the
quality of surgical gloves in order to provide a safer and more comfortable environment for the
surgical personnel and patients. # 1999 British Occupational Hygiene Society. Published by
Elsevier Science Ltd. All rights reserved.
276
Data collection
Between May 1, 1998 and May 20, 1998, 66
health care professionals, 32 (48.5%) males and 34
(51.5%) females, who routinely wore rubber gloves
in operating rooms voluntarily participated in this
glove evaluation trial, including 35 physicians, 30
nurses and one technician. Gloves were labelled
with A, B, C, and D, respectively for four dierent
brands, and were distributed to the participants
according to a randomization table generated by
computer. However, it was not possible to achieve
blinding due to the manufacture mark on the plastic
bags of gloves. A standardized structured questionnaire was self-administered by volunteers immediately after the procedure. Each individual was asked
to try wearing two pairs of each of the four brands.
Variables studied
We used the self-administered questionnaire to
collect variables of interests, including the demographic information, allergic history, variables of
glove quality (i.e., perforation, ventilation, tness,
allergic reaction, elasticity, thickness, powder, and
satisfaction), and the type and length of procedure.
A sample of the questionnaire is provided in
Appendix A. The glove perforation on both hands,
including the number of pinholes, was visually
examined by participants before and after the surgical procedure. The reason for the perforation, the
frequency of electric shock punctures (during electrocautery) due to the glove defect, the occurrence
and types of symptoms of adverse reactions to the
trial gloves, and the frequency and reasons for changing gloves during a procedure were also recorded
by participants. Other quality measure scores were
decided by individuals' judgement.
Statistical analysis
Frequencies of defect gloves, allergy events, and
other binary measures for quality of the four dierent brands were compared by using a chi-square test
or Fisher's exact test when appropriate. We also
compared the quality measures between the gloves
worn for less than or equal to two hours and those
worn for longer than two hours. Analysis of variance (ANOVA) and Schee's multiple comparison
procedure were performed on continuous variables.
Since there were volunteers who tested more than
one glove, the generalized estimating equation
(GEE) was used to adjust the autocorrelation
among observations from the same individuals for
multiple regression analysis. Odds ratios and 95%
condence intervals were calculated for all quality
measures with brand B as the reference group.
Allergy history
Seafood
Penicillin
Dust/pollen
Animal hair
Glove powder
Asthma
Allergic rhinitis
Hay fever
To specic food
1
1
7
2
1
1
4
1
1
%
8.3
8.3
58.3
16.7
8.3
8.3
33.3
8.3
8.3
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278
Brands
A
B
C
D
Overall
No.
Mean2S.D.
Median
Range
40
74
23
31
64.1238.1
95.8287.0
87.8256.4
83.4256.7
60
60
90
60
3150
10600
10240
0180
168
84.9269.3
60
0600
Table 3. Glove-wearing time-adjusted odds ratio of quality measures from generalized estimation equations (GEE)
method
Brand
Events
Odds Ratio
(95% C.I.)
Odds Ratio
(95% C.I.)
Odds Ratio
(95% C.I.)
0.39
(0.044.22)
7.30*
(1.536.2)
1.58
(0.55.0)
6.12**
(1.524.8)
5.85*
(1.130.5)
14.9**
(4.055.5)
43.5**
(4.7402.9)
20.4**
(4.493.6)
7.02**
(2.420.3)
1.53
(0.268.9)
2.92
(0.7611.2)
2.40
(0.668.7)
5.60
(0.9134.4)
6.17
(0.7650.3)
4.80
(0.9524.3)
11.6*
(1.1118.5)
6.0*
(1.0135.7)
2.13
(0.4310.6)
2.21
(0.578.5)
5.11
(0.4953.4)
1.96
(0.685.6)
10.9**
(2.448.9)
19.4**
(3.1122.5)
24.23**
(7.282.0)
26.1**
(3.5191.6)
10.5**
(2.151.3)
7.86*
(2.524.8)
occurred when unnoticed pinholes existed. That procedures longer than 2 hours posed a higher risk of
perforations was also consistent with studies by
Miller and Apt (1993) and Hansen et al. (1992).
However, we did not nd surgeons with a greater
Fig. 1. Results of glove-quality evaluation. *: p<0.05; **: p<0.01 by w2 test or Fisher's exact test when appropriate.
279
280
Employee No.: __
Surgical Room No.: __
Date: __ / __ / __
Name/Purpose of the pro______
Length of use: __ hr __ min
cedure:
1.0. Was one pair of gloves worn throughout the procedure? __ 1. No __ 2. Yes (Skip to 2.0)
1.1. Number of pairs used during the same procedure
__ Pairs
1.2. Length of use for the 1st pair (Brand code __)
__ hr __ min
Length of use for the 2nd pair (Brand code __)
__ hr __ min
1.3. Reasons for changing
__ 1. Defect prior to use
gloves?
__ 2. Allergic reaction
__ 3. Perforation or electrical puncture
__ 4. Sweating wet
__ 5. Too big/small (Circle one)
__ 6. Others ______
2.0. Please answer the following questions for one specic pair of gloves. If more than one pair was
used, please use separate questionnaires for dierent pair.
Brand code: A B C D (Circle one)
1.
2.
3.
4.
Ventilation
Elasticity
Thickness
Amount of powder
Overall satisfaction
Suggest to purchase
Left Hand
Right Hand
__ 1. No __ 2. Yes
__ 1. No __ 2. Yes
__ 1. No __ 2. Yes (__ holes)
__ 1. No __ 2. Yes (__ holes)
__ 1. No __ 2. Yes (__ times)
__ 1. No __ 2. Yes (__ times)
__ 1. Being cut
__ 1. Being cut
__ 2. Being punctured
__ 2. Being punctured
__ 3. Torn
__ 3. Torn
__ 4. Defect prior to use
__ 4. Defect prior to use
__ 5. Unknown reason
__ 5. Unknown reason
__ 6. Others ______
__ 6. Others ______
__ 1. Just right
__ 2. Too big/loose
__ 3. Too small/tight
__ 1. No (Skip to 8) __ 2. Yes
__ 1. Rash
__ 2. Eyes symptoms
__ 3. Respiratory symptoms
__ 4. Itching
__ 5. Others
______
__ 1. Good
__ 2. Fair
__ 3. Poor
__ 1. Good
__ 2. Fair
__ 3. Poor
__ 1. Too thick
__ 2. Adequate
__ 3. Too thin
__ 1. Too little
__ 2. Adequate
__ 3. Too much
__ 1. Good
__ 2. Fair
__ 3. Poor
__ 1. No
__ 2. Yes
__ 3. No opinion
281
REFERENCES