Yulex Glove Prospective Study in Spina Bifida

NCT01133288 | Terminated Results

• 1 other identifier: NA_00024249
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spina Bifida; Latex Allergy

Outcome Measures

Primary Outcomes (1)

• Sensitization to Yulex

  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.

  Approximately 3 months

Secondary Outcomes (1)

• Immune Response to Yulex

  3 months

Interventions

Yulex gloves DEVICE

Study participants will be asked to wear Yulex gloves for routine bowel and bladder care (\~30 minutes per day) over a 3 month period.

Also known as: Yulex Natural Rubber Examination Gloves, Powder-Free, FDA 510(k) Number: K063810

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• Johns Hopkins University: collaborator

Study Sites (1)

Hugo W. Moser Research Institute at Kennedy Krieger Inc.

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Spinal Dysraphism; Latex Hypersensitivity

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypersensitivity; Immune System Diseases

Limitations and Caveats

The study was not completed because funding was never received. The two (2/7)enrolled participants who met screening eligibility criteria were terminated early without receiving the yulex glove intervention.

Results Point of Contact

• Title: Eric Levey, M.D.
• Organization: Kennedy Krieger Institute

levey@kennedykrieger.org

443-923-9148

Study Officials

• Eric B Levey, M.D

  Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant/co-investigator

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 28, 2010
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 23, 2011
• Results First Posted: December 23, 2011

Record last verified: 2011-11

Locations

US (1)