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Predictive patch testing of "Medigloves" on humans using the repeated insult technique
P Timpatanapong1, S Charuwichitratana, N Rajatanavin
1Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bankok, Thailand.
Abstract:
The predictive patch tests using the repeated insult technique with pieces of ETO sterilized "Medigloves" on 200 human subjects showed negative allergic reactions in all cases. Therefore, the sensitizing potential of "Medigloves" is quite low, if any. Mild to severe forms of miliaria rubra were occasionally observed in about one fourth of the subjects during the induction and challenge periods since the weather was quite warm and humid. However, three subjects who developed more pronounced miliaria rubra on the skin underneath rubber-glove squares were selected for provocative use tests. The results were negative in all cases. A subject who showed a false-positive allergic reaction also showed negative results in a provocative use test and in patch tests with standard rubber chemicals and pieces of "Medigloves" from various batches. Occlusive patch tests for 72 hours with Mediglove pieces from the same batch used in the initial test challenge phase were repeatedly negative when performed during the cool time of the year. In tropical countries, predictive closed patch tests employing solid occlusive materials should be done during cool weather in order to prevent or minimize the occurrence of miliaria. In hot weather, this is a common source of false positive reactions.
Insights
Medigloves demonstrated a low potential for allergic reactions in human subjects. However, heat and humidity can cause false positive results in patch testing, necessitating testing during cooler weather.
Area of Science:
- Dermatology
- Allergology
- Occupational Health
Background:
- Medical gloves are essential in healthcare settings.
- Assessing the allergenic potential of medical gloves is crucial for patient and healthcare worker safety.
- Ethylene oxide (ETO) sterilization is a common method for medical devices.
Purpose of the Study:
- To evaluate the sensitizing potential of ETO-sterilized "Medigloves" in human subjects.
- To investigate the occurrence of miliaria and its impact on patch test results.
- To determine the reliability of predictive patch tests in different climatic conditions.
Main Methods:
- Predictive patch tests using the repeated insult technique on 200 human subjects with "Medigloves" pieces.
- Provocative use tests on subjects who developed miliaria rubra.
- Occlusive patch tests during different seasons and climatic conditions.
Main Results:
- All subjects showed negative allergic reactions to "Medigloves" in initial patch tests.
- Miliaria rubra was observed in approximately 25% of subjects during warm, humid weather.
- Provocative use tests and further patch tests yielded negative results, indicating no true allergic sensitization.
- Occlusive patch tests performed during cooler weather were negative.
Conclusions:
- "Medigloves" exhibit a low sensitizing potential.
- Miliaria can cause false positive results in predictive patch tests, particularly in hot and humid climates.
- Predictive closed patch tests in tropical regions should be conducted during cooler periods to ensure accurate results and minimize false positives.