Bacterial DiseasesPhase 2NCT00170586
Novel Protective Underglove
A Phase 2 study testing Underglove coating (skin barrier) in people with Bacterial Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Diseases
- What is being tested?
- Underglove coating (skin barrier)
- Type of treatment
- Medical device
- How many people
- 325 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Aug 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biomedical Development Corporation
San Antonio, Texas, 78216
About this study
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.
Read the 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 upon application to skin, has been developed to reduce transmission of bacteria and bloodborne pathogens, and is expected to protect skin from the detrimental effects of chronic glove occlusion and hand washing. Due to the increased prevalence of human immunodeficiency virus (HIV) and hepatitis, the efficacy of surgical and examination gloves has become an important safety issue, especially for health care workers where occupational exposure to pathogens in blood or other body fluids is common. Transmission can occur from both caregiver to patient, and from patient to caregiver. However, glove leaks are frequent and the potential for pathogen transmission is of great concern. In addition, as awareness of the hazards from bloodborne pathogen transmission increased along with AIDS awareness in the 1990s, the concomitant increased use of disposable gloves has adversely affected skin condition, causing increased cumulative irritation contact dermatitis and heightened dermal sensitization to natural rubber latex. This unique thin film technology is a blend of polyvinylidene fluoride (PVDF) and acrylic polymers that forms thin membrane coatings that provide a tough, flexible barrier to liquids, yet have a "breathable" microporous structure. PVDF-based coatings are applied as a fast drying liquid solution that casts an adherent contiguous film directly on the skin upon drying. The liquid solution is antimicrobial on contact, and after drying, the coatings are durable, resistant to penetration by pathogens, and stay intact for 8 hours or longer. Phase I studies established the feasibility of using the PVDF technology as a protective barrier to be worn underneath gloves. The Phase I studies focused on exploiting the coating's inherent hydrophobicity to create a barrier to bacterial and viral penetration while maintaining breathability and comfort. The coatings demonstrated barrier function to viral and bacterial pathogens in vitro, proved to be safe in animal safety studies, and were shown to be a barrier to liquid in human trials. Phase II studies will complete the development of the PVDF technology for use as a novel protective underglove. The following aims have been designed to demonstrate safety and efficacy of the product and to satisfy Food and Drug Administration (FDA) requirements: implement Good Manufacturing Practices (GMP) and establish packaging; evaluate coating formulations in human subjects for effects on skin physiology; and demonstrate safety of coatings in human studies. A skin coating to be worn under gloves that is antimicrobial on contact, provides a barrier to bloodborne and bacterial pathogens, is a barrier to latex proteins, and could improve skin conditions on hands, would be beneficial to healthcare in the workplace and likewise have significant commercial potential.
- Conditions
- Bacterial Diseases
- Being tested
- Underglove coating (skin barrier)
- Keywords
- Underglove, polyvinylidene fluoride, acrylic polymer
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Underglove coating (skin barrier)Device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial DiseasesStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 325 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170586
- Sponsor's protocol ID
- 03-241
- Other IDs
- PHS 2002-2
- Status last verified
- Mar 2007
- First submitted
- 13 Sep 2005
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Protective Underglove
- ClinicalTrials.gov ID
- NCT00170586
- Acronym / sponsor ID
- 03-241
- Conditions
- Bacterial Diseases
- Keywords
- Underglove, polyvinylidene fluoride, acrylic polymer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Sep 2003
- Study completion
- Aug 2005
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 upon application to skin, has been developed to reduce transmission of bacteria and bloodborne pathogens, and is expected to protect skin from the detrimental effects of chronic glove occlusion and hand washing. Due to the increased prevalence of human immunodeficiency virus (HIV) and hepatitis, the efficacy of surgical and examination gloves has become an important safety issue, especially for health care workers where occupational exposure to pathogens in blood or other body fluids is common. Transmission can occur from both caregiver to patient, and from patient to caregiver. However, glove leaks are frequent and the potential for pathogen transmission is of great concern. In addition, as awareness of the hazards from bloodborne pathogen transmission increased along with AIDS awareness in the 1990s, the concomitant increased use of disposable gloves has adversely affected skin condition, causing increased cumulative irritation contact dermatitis and heightened dermal sensitization to natural rubber latex. This unique thin film technology is a blend of polyvinylidene fluoride (PVDF) and acrylic polymers that forms thin membrane coatings that provide a tough, flexible barrier to liquids, yet have a "breathable" microporous structure. PVDF-based coatings are applied as a fast drying liquid solution that casts an adherent contiguous film directly on the skin upon drying. The liquid solution is antimicrobial on contact, and after drying, the coatings are durable, resistant to penetration by pathogens, and stay intact for 8 hours or longer. Phase I studies established the feasibility of using the PVDF technology as a protective barrier to be worn underneath gloves. The Phase I studies focused on exploiting the coating's inherent hydrophobicity to create a barrier to bacterial and viral penetration while maintaining breathability and comfort. The coatings demonstrated barrier function to viral and bacterial pathogens in vitro, proved to be safe in animal safety studies, and were shown to be a barrier to liquid in human trials. Phase II studies will complete the development of the PVDF technology for use as a novel protective underglove. The following aims have been designed to demonstrate safety and efficacy of the product and to satisfy Food and Drug Administration (FDA) requirements: implement Good Manufacturing Practices (GMP) and establish packaging; evaluate coating formulations in human subjects for effects on skin physiology; and demonstrate safety of coatings in human studies. A skin coating to be worn under gloves that is antimicrobial on contact, provides a barrier to bloodborne and bacterial pathogens, is a barrier to latex proteins, and could improve skin conditions on hands, would be beneficial to healthcare in the workplace and likewise have significant commercial potential.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Underglove coating (skin barrier) | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
Related trials for Bacterial Diseases
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingObservational study
Characterization of Small Intestinal Bacterial Overgrowth and Intestinal Barrier-Related Biomarkers in Patients With Severe Periodontitis
Periodontitis (Stage 3), Periodontitis Stage IV
Not yet recruiting
Gastric String Test Combined With a Rapid Antigen Assay for Helicobacter Pylori Detection
Helicobacter Pylori
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Underglove coating (skin barrier) in people with Bacterial Diseases, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2010.