Novel Protective Underglove

NCT00170586 | Completed Phase 2

• 2 other identifiers: 03-241PHS 2002-2
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

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 examination gloves are worn by health care workers to reduce the risk of workers catching germs from patients or patients catching germs from workers. The purpose of this study is to further develop polyvinylidene fluoride coatings for use as a protective coating worn underneath the gloves. Some health care workers may have tiny cuts on their hands that need to be protected, and gloves can have defects such as tiny holes that can allow germs to travel through them. The undercoating can add an additional layer of protection under gloves. The coating is applied in liquid form to hands and dries as a film without wrinkling, tearing, lifting, or bubbling. The liquid contains chemicals that fight germs. The coating also provides protection from skin irritation caused by the latex in some gloves.

Conditions

Bacterial Diseases

Keywords

Underglove, polyvinylidene fluoride, acrylic polymer

Interventions

Underglove coating (skin barrier) DEVICE

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• \) 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Biomedical Development Corporation

San Antonio, Texas, 78216, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2003
• Study Completion: August 1, 2005
• Last Updated: August 27, 2010

Record last verified: 2007-03

Locations

US (1)