Yulex Glove Prospective Study in Spina Bifida

This study has been terminated.
(The funder never paid for the study.)
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Charles Curry, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier:
NCT01133288
First received: May 26, 2010
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Spina Bifida
Latex Allergy
Device: Yulex gloves

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Yulex Glove Prospective Study

Resource links provided by NLM:


Further study details as provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 7
Study Start Date: July 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Yulex gloves
    Study participants will be asked to wear Yulex gloves for routine bowel and bladder care (~30 minutes per day) over a 3 month period.
    Other Names:
    • Yulex Natural Rubber Examination Gloves, Powder-Free
    • FDA 510(k) Number: K063810
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals with spina bifida between the ages of 18 and 60 who exhibit positive serology to latex (Hevea Brasiliensis).

Exclusion Criteria:

  • Possible exclusion criteria include age under 18, does not have spina bifida, or does not exhibit positive serology to latex (Hevea Brasiliensis).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133288

Locations
United States, Maryland
Hugo W. Moser Research Institute at Kennedy Krieger Inc.
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Johns Hopkins University
Investigators
Principal Investigator: Eric B Levey, M.D Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  More Information

No publications provided

Responsible Party: Charles Curry, Research assistant/co-investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT01133288     History of Changes
Other Study ID Numbers: NA_00024249
Study First Received: May 26, 2010
Results First Received: July 11, 2011
Last Updated: November 21, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Spinal Dysraphism
Latex Hypersensitivity
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014