Effectiveness of Antimicrobial Impregnated Scrubs in a Healthcare SettingNCT00971373
Pilot Study to Determine the Effectiveness of Antimicrobial Healthcare Worker's (HCW) Hands and Clothing
A study testing Vestagen scrubs in people with Effectiveness of Antimicrobial Impregnated Scrubs in a Healthcare Setting, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
This is a pilot study to determine the effectiveness of antimicrobial scrubs on bacterial burden of HCW's hands and clothing in a clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Effectiveness of Antimicrobial Impregnated Scrubs in a Healthcare Setting
- What is being tested?
- Vestagen scrubs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jan 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HCWs in the MRICU
Who cannot join
- Under the age of 18 who is not a healthcare worker in the MRICU
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23219
About this study
Official title: Pilot Study to Determine the Effectiveness of Antimicrobial Scrubs on Bacterial Burden of HCW's Hands and Clothing in a Clinical Setting
This is a pilot study to determine the effectiveness of antimicrobial scrubs on bacterial burden of HCW's hands and clothing in a clinical setting.
Read the detailed description
Goals of the pilot study:
- Compare CFU counts on antimicrobial vs standard scrubs in a clinical setting
- Assess CFU counts on the hands of HCWs wearing antimicrobial vs non-antimicrobial scrubs
- Assess HCW hand hygiene compliance during the study protocol
- Correlate device associated infection rates during protocol to historical controls
- Assess feasibility of applying protocol to a longer,12-24 month, prospective crossover-trial to definitively study and assess the impact of antimicrobial scrubs on HCW apparel and hand colonization, control of multi-drug resistance organisms, hand hygiene compliance, and device associated hospital acquired infection rates.
II. Design
Cross-over trial in an ICU or Hospital Ward
III. Outcome Measures
- CFU count on participants
- Hands
- Scrubs
- Antimicrobial scrubs vs standard scrubs
- Hand Hygiene Compliance
- Device associated nosocomial infections rates
- Being tested
- Vestagen scrubs
- Keywords
- antimicrobial, epidemiology, bacteriology, CFU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestagen scrubsOther
Also called Vestagen, Nanosphere
antimicrobial impregnated textile
| Study group | Role | What they receive |
|---|---|---|
| Exp Scrubs | Experimental | antimicrobial impregnated scrubs Receives: Other: Vestagen scrubs |
| Non-antimicrobial scrubs | No intervention | Non-antimicrobial scrubs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Antimicrobial impregnated scrubs
Measured: 4 months
Secondary outcomes (1)
HCW hand and scrub average bacterial counts
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness of Antimicrobial Impregnated Scrubs in a Healthcare SettingStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gonzalo Bearman, M.D., MPH, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971373
- Sponsor's protocol ID
- HM12358
- Status last verified
- Jun 2016
- First submitted
- 1 Sep 2009
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Determine the Effectiveness of Antimicrobial Scrubs on Bacterial Burden of HCW's Hands and Clothing in a Clinical Setting
- ClinicalTrials.gov ID
- NCT00971373
- Acronym / sponsor ID
- HM12358
- Keywords
- antimicrobial, epidemiology, bacteriology, CFU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Sep 2009 (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.
This is a pilot study to determine the effectiveness of antimicrobial scrubs on bacterial burden of HCW's hands and clothing in a clinical setting.
Detailed description
Goals of the pilot study:
- Compare CFU counts on antimicrobial vs standard scrubs in a clinical setting
- Assess CFU counts on the hands of HCWs wearing antimicrobial vs non-antimicrobial scrubs
- Assess HCW hand hygiene compliance during the study protocol
- Correlate device associated infection rates during protocol to historical controls
- Assess feasibility of applying protocol to a longer,12-24 month, prospective crossover-trial to definitively study and assess the impact of antimicrobial scrubs on HCW apparel and hand colonization, control of multi-drug resistance organisms, hand hygiene compliance, and device associated hospital acquired infection rates.
II. Design
Cross-over trial in an ICU or Hospital Ward
III. Outcome Measures
- CFU count on participants
- Hands
- Scrubs
- Antimicrobial scrubs vs standard scrubs
- Hand Hygiene Compliance
- Device associated nosocomial infections rates
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exp Scrubs | Experimental | Other: Vestagen scrubsantimicrobial impregnated scrubs |
| Non-antimicrobial scrubs | No intervention | –Non-antimicrobial scrubs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HCWs in the MRICU
Key exclusion criteria (1 listed)
- Under the age of 18 who is not a healthcare worker in the MRICU
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 |
|---|---|---|
| Vestagen scrubsAlso: Vestagen, Nanosphereantimicrobial impregnated textile | Other | Exp Scrubs |
Primary outcome
Effectiveness of Antimicrobial impregnated scrubs
Time frame: 4 months
1 secondary outcome
HCW hand and scrub average bacterial counts
Time frame: 4 months
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 8 Jun 2016.
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.
Gonzalo Bearman, M.D., MPH principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestagen scrubs in people with Effectiveness of Antimicrobial Impregnated Scrubs in a Healthcare Setting, run by Virginia Commonwealth University 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 1 inclusion and 1 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 8 Jun 2016. 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.
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.
What does the primary outcome measure?
Effectiveness of Antimicrobial impregnated scrubs (time frame: 4 months). It is what the study was designed to measure, not a finding.
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 8 Jun 2016.