Bacterial ContaminationNCT01594580
Contamination of Hospital Scrubs
A study testing Antimicrobial impregnated scrubs and Non-impregnated scrubs in people with Bacterial Contamination, run by University of Maryland, Baltimore.
Trial summary
This study will test if nurses wearing scrubs treated with an antimicrobial agent while performing patient care will: Decrease the amount of bacterial contamination on scrubs at the end of a typical hospital shift during routine use after home laundering This study will gather information by obtaining swabs from… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacterial Contamination
- What is being tested?
- Antimicrobial impregnated scrubs and Non-impregnated scrubs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Dec 2012
- 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
- Nursing staff engaging in direct patient care
- Working in select/participating intensive care and intermediate care units
- Working at least 8 day shifts in one month (study period)
Who cannot join
- Pregnant
- Unable to provide consent
- Unable to follow study schedule
About this study
Official title: A Novel Agent to Decrease Contamination of Hospital Scrubs
This study will test if nurses wearing scrubs treated with an antimicrobial agent while performing patient care will:
- Decrease the amount of bacterial contamination on scrubs at the end of a typical hospital shift during routine use after home laundering
This study will gather information by obtaining swabs from scrubs treated with an antimicrobial and from non-treated scrubs.
Read the detailed description
The outcome of interest is the contamination of scrubs with Staphylococcus aureus, Enterococcus species or Gram-negative bacteria as determined by surface swabs of healthcare worker scrubs after a full 8-hour shift. The outcomes will be analyzed both individually and collectively.
Contamination will be defined as:
- A swab that is determined to be positive for any Staphylococcus aureus, Enterococcus species, or Gram-negative bacteria after a hospital shift.
- Conditions
- Bacterial Contamination
- Being tested
- Antimicrobial impregnated scrubs, Non-impregnated scrubs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial impregnated scrubsOther
Scrubs are impregnated with an antimicrobial product
Non-impregnated scrubsOther
| Study group | Role | What they receive |
|---|---|---|
| Antimicrobial impregnated scrubs | Experimental | Those randomized to this arm of the study will wear scrubs impregnated with an antimicrobial. Receives: Other: Antimicrobial impregnated scrubs |
| Non-impregnated scrubs | Placebo comparator | Those randomized to this arm of the study will wear scrubs not impregnated with an antimicrobial. Receives: Other: Non-impregnated scrubs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial contamination of scrubs
Contamination will be defined as:
- A swab that is determined to be positive for any of Staphylococcus aureus, Enterococcus species, or Gram-negative bacteria after a hospital shift.
Measured: Outcome will be assessed at the end of the hospital shift ( approx 8 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial ContaminationStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Kristie Johnson, University of Maryland, Baltimore
- Investigators
- J Kristie Johnson, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594580
- Sponsor's protocol ID
- HP-00051506
- Status last verified
- Jul 2023
- First submitted
- 7 May 2012
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Agent to Decrease Contamination of Hospital Scrubs
- ClinicalTrials.gov ID
- NCT01594580
- Acronym / sponsor ID
- HP-00051506
- Conditions
- Bacterial Contamination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 May 2012 (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 study will test if nurses wearing scrubs treated with an antimicrobial agent while performing patient care will:
- Decrease the amount of bacterial contamination on scrubs at the end of a typical hospital shift during routine use after home laundering
This study will gather information by obtaining swabs from scrubs treated with an antimicrobial and from non-treated scrubs.
Detailed description
The outcome of interest is the contamination of scrubs with Staphylococcus aureus, Enterococcus species or Gram-negative bacteria as determined by surface swabs of healthcare worker scrubs after a full 8-hour shift. The outcomes will be analyzed both individually and collectively.
Contamination will be defined as:
- A swab that is determined to be positive for any Staphylococcus aureus, Enterococcus species, or Gram-negative bacteria after a hospital shift.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antimicrobial impregnated scrubs | Experimental | Other: Antimicrobial impregnated scrubsThose randomized to this arm of the study will wear scrubs impregnated with an antimicrobial. |
| Non-impregnated scrubs | Placebo comparator | Other: Non-impregnated scrubsThose randomized to this arm of the study will wear scrubs not impregnated with an antimicrobial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Nursing staff engaging in direct patient care
- Working in select/participating intensive care and intermediate care units
- Working at least 8 day shifts in one month (study period)
Key exclusion criteria (3 listed)
- Pregnant
- Unable to provide consent
- Unable to follow study schedule
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 |
|---|---|---|
| Antimicrobial impregnated scrubsScrubs are impregnated with an antimicrobial product | Other | Antimicrobial impregnated scrubs |
| Non-impregnated scrubs | Other | Non-impregnated scrubs |
Primary outcome
Bacterial contamination of scrubs
Time frame: Outcome will be assessed at the end of the hospital shift ( approx 8 hours)
Contamination will be defined as: * A swab that is determined to be positive for any of Staphylococcus aureus, Enterococcus species, or Gram-negative bacteria after a hospital shift.
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 21 Jul 2023.
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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.
J Kristie Johnson, PhD principal investigator
University of Maryland, Baltimore
Questions about this trial
What is this clinical trial studying?
A study testing Antimicrobial impregnated scrubs and Non-impregnated scrubs in people with Bacterial Contamination, run by University of Maryland, Baltimore.
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 3 inclusion and 3 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 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Bacterial contamination of scrubs (time frame: Outcome will be assessed at the end of the hospital shift ( approx 8 hours)). 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 21 Jul 2023.