Status:
COMPLETED
Novel Protective Underglove
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Bacterial Diseases
Eligibility:
All Genders
18-72 years
Phase:
PHASE2
Brief Summary
Bloodborne pathogens are infectious bacteria, viruses, or other disease-causing germs carried in blood or other body fluids. These germs include hepatitis B and C viruses and HIV. Surgical and examina...
Detailed Description
The goal of this project is to complete development of a unique thin film technology to be used as a skin barrier underneath surgical and examination gloves. The technology, which is antimicrobial upo...
Eligibility Criteria
Inclusion
- Aim 2a. and Aim 2b1. and Aim 2b2.
- greater than 18 years of age;
- healthy subjects as determined by brief medical history;
- skin in the test area must be devoid of tattoos, scars, moles, vitiligo, keloids, or breaks in the skin;
- capable of reading, understanding and signing the consent form.
- Aim 3.
- Males/females, 18-70 years of age;
- healthy subjects as determined by medical history;
- capable of reading, understanding and signing the consent form.
- Aim 2.
- 18-72 years of age;
- healthy subjects as determined by a brief medical history;
- capable of reading, understanding and signing the consent form;
- skin in the test area must be devoid of tattoos, scars, moles, vitiligo, keloids, or breaks in the skin.
Exclusion
- Aim 2a. and Aim 2b1. and Aim 2b2. and Aim 2.
- history or current evidence of a chronic or infectious skin disease
- pregnant or lactating females. Participating female subjects must agree to use adequate contraceptive measures during the trial. Before entering the study, women of childbearing age will be tested for pregnancy.
- Aim 3.
- 1\) active, clinically significant skin diseases such as eczema, atopic dermatitis, psoriasis and skin cancer; 2) severe, chronic asthma; 3) insulin dependent diabetes mellitus or hyperthyroidism (metabolic diseases); 4) routine use of anti-inflammatory medications (i.e., aspirin, ibuprofen, corticosteroids, immunosuppressive drugs or anti-histamines; 5) use of topical drugs at test sites; 6) immunological disorders such as HIV positive, AIDS or systemic lupus erythematosus; 7) participation in any patch test for cumulative irritation or sensitization within the last four weeks; 8) women who are pregnant, lactating, or planning to become pregnant within the next six weeks; 9) mastectomy for cancer involving removal of the lymph nodes; 10) allergy to tapes; 11) subject who has damaged skin in or around test sites which include sunburn, uneven skin tones, tattoos, scars or other disfiguration of the test site; 12) subject who has a condition or is taking or had taken a medication which, in the Investigator's judgement, makes the subject ineligible or places the subject at undue risk; 13) subject who has sensitivity to any of the ingredients in the test articles.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT00170586
Start Date
September 1 2003
End Date
August 1 2005
Last Update
August 27 2010
Active Locations (1)
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1
Biomedical Development Corporation
San Antonio, Texas, United States, 78216