View clinical trials related to Latex Hypersensitivity.
Filter by:Background: Global guidelines recommend the use of personal protective equipment due to the high risk of contagiousness of COVID-19 disease. The increase in COVÄ°D-19 patients in the last two years has increased the rate of use of latex gloves in nurses. It is not known how the increase in the use of latex gloves affects the complaints of latex allergy in nurses. Aim: The aim of this study is to determine the rates of latex glove use and allergic complaints related to the use of latex gloves during the COVID-19 pandemic in hospital nurses.
Study objectives Primary objective: This study wants to evaluate the safety of a latex safe protocol as proposed by the Australasian Society of Clinical Immunology and Allergy. In other words,the investigators hope to demonstrate that patients with known latex allergy or latex sensitisation can be treated safely in operating theatres without special requirements towards scheduling provided that all powdered latex gloves are removed from the OR environment( preparation rooms, theatres, recovery room and surroundings). In contrast, earlier guidelines require the theatre to be left unused during at least 3 hours before a patient with suspected latex allergy can be operated on in this theatre. Secondary objectives: - The investigators want to evaluate to what extend patients who report a latex allergy show risk factors of latex allergy. - To investigate to what extend latex allergy was proven by laboratory testing or skin testing in patients who report a latex allergy. - Type of latex allergic reaction when patients report a latex allergy. - The level of satisfaction of surgeons and OR scheduling staff with the new latex safe protocol and with the switching to powder free latex gloves.
This study is to evaluate the safety of Yulex gloves when used by individuals who have documented allergy to natural rubber latex from Hevea brasiliensis. Yulex is a latex from a different plant (Guayule) and in previous studies shows no cross-reactivity to Hevea latex and has not been allergenic in workers exposed to Yulex. The FDA has approved Yulex gloves for use in the general population and has recognized and labeled these gloves as Hevea Latex-free. The labeling still includes a precaution that Yulex gloves may pose a risk for development of allergy because Yulex does contain a small amount of Guayule protein. Yulex Corporation has proposed doing further studies to demonstrate safety and lack of allergenicity in a population that is prone to latex allergy. In the proposed pilot study, the investigators goal is to complete the protocol on 10 adults with spina bifida who are allergic to natural rubber latex who will wear Yulex gloves as part of their regular bladder and bowel care for approximately 30 minutes daily over a 3 month period. The investigators anticipate that the investigators will need to recruit and enroll up to 50 study participants to achieve a final sample of 10 adults with complete study data. Individuals with a history of anaphylaxis will be excluded from the study. The study participants will be tested for Yulex allergy by Glove Puncture Test as well as serology at the beginning and end of the study. The FDA Devices group has reviewed the study design and agreed that this is a suitable first pilot study.