Yulex Glove Prospective Study in Spina Bifida
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Yulex Glove Prospective Study|
- Sensitization to Yulex [ Time Frame: Approximately 3 months ] [ Designated as safety issue: Yes ]The primary study outcome will be an assessment for sensitization to Yulex as determined by serological assay for Guayule-specific IgE antibodies. The development of a detectable IgE immune response will be considered a positive study.
- Immune Response to Yulex [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]A secondary study outcome is the development of an immune response to Yulex using a human IgG anti-Guayule immunoassay. The development of a detectable IgG immune response will be considered a positive study.
|Study Start Date:||July 2009|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Device: Yulex gloves
- Yulex Natural Rubber Examination Gloves, Powder-Free
- FDA 510(k) Number: K063810
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133288
|United States, Maryland|
|Hugo W. Moser Research Institute at Kennedy Krieger Inc.|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Eric B Levey, M.D||Hugo W. Moser Research Institute at Kennedy Krieger, Inc.|