Disease TransmissionASCOTNCT02645214
Antiseptic Scrub Contamination and Transmission Trial
A study testing Non-antiseptic scrubs and Antiseptic scrubs in people with Disease Transmission, run by Duke University at 1 site in United States.
Trial summary
This study is a prospective, blinded, randomized, controlled trial (RCT) with a crossover design to determine if antiseptic-impregnated surgical scrubs decrease the burden of healthcare providers (HCP) clothing contamination compared to standard, control surgical scrubs following a 12-hour ICU shift. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disease Transmission
- What is being tested?
- Non-antiseptic scrubs and Antiseptic scrubs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jan 2016
- 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
- All intensive care unit (ICU) nurses at Duke Medical Center are eligible to participate in this study.
Who cannot join
- Nurses outside the Duke Medical Center ICU will not be eligible to participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Antiseptic Scrub Contamination and Transmission Trial: A Randomized Controlled Trial to Evaluate the Impact of Antiseptic Scrubs on Bacterial Contamination.
This study is a prospective, blinded, randomized, controlled trial (RCT) with a crossover design to determine if antiseptic-impregnated surgical scrubs decrease the burden of healthcare providers (HCP) clothing contamination compared to standard, control surgical scrubs following a 12-hour ICU shift.
Read the detailed description
The investigators will perform a 3-arm prospective, blinded, randomized, controlled trial with a cross-over design to determine if HCP who wear antiseptic-impregnated clothing (i.e., surgical scrubs) will acquire and transmit fewer pathogens than HCP wearing standard clothing.
A total of 40 intensive care unit (ICU) nurses (from the Medical and Surgical ICUs in the Duke Medical Pavilion) will be enrolled and sign a consent form to participate in the study. Their main task will be to wear control (non- antiseptic) scrubs (Arm 1) and two different types of antiseptic-impregnated scrubs (Arms 2 and 3). Subjects will be randomized to one of 6 strategies. Each nurse typically cares for two patients each day and will be enrolled for three consecutive days (or shifts, if they do not work for 3 days in a row). Once the nurses have consented to participate in this project, the study coordinator will provide the 3 sets of scrubs and will label them with numbers, thus blinding the nurses to which scrubs they will wear on which day. The nurse will wear the scrubs on the 3 pre-arranged shifts.
Data will be summarized using standard statistical methods. The investigators will utilize linear mixed models to compare relative differences in the amount of contamination between arms at the end of the shift to adjust for our crossover study design. Mixed effects logistic regression models will be used to compare proportions. All calculations will be adjusted for the amount of environmental contamination observed during the shift and contamination on HCP clothing in the beginning of the shift. Statistical significance for two primary comparisons (each antiseptic scrub versus control) will be corrected for multiple comparisons.
This is a minimal risk study and the investigators have no safety concerns from the patients or nurses as relates to obtaining swabs and room cultures, nor with wearing the scrubs and having them cultured. Data will be stored on encrypted Duke Medicine servers (participant log \& study IDs) and/or in our REDCap database (all other data collected for the study).
- Conditions
- Disease Transmission
- Being tested
- Non-antiseptic scrubs, Antiseptic scrubs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-antiseptic scrubsOther
Antiseptic scrubsOther
| Study group | Role | What they receive |
|---|---|---|
| Control scrubs (non-antiseptic) | Placebo comparator | subject will wear control scrubs for the duration of a 12-hour ICU shift Receives: Other: Non-antiseptic scrubs |
| Antiseptic Impregnated Scrubs Type 1 | Active comparator | subject will wear antiseptic impregnated scrubs-type 1 for the duration of a 12-hour ICU shift Receives: Other: Antiseptic scrubs |
| Antiseptic Impregnated Scrubs Type 2 | Active comparator | subject will wear antiseptic impregnated scrubs-type 2 for the duration of a 12-hour ICU shift Receives: Other: Antiseptic scrubs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in total acquired contamination (Total CFU) on HCP clothing at the end of a 12-hour ICU shift.
Measured: At the end of a 12-hour ICU shift
Secondary outcomes (5)
The presence or absence of individual specific pathogens: S. aureus (MRSA or MSSA), Enterococci (VRE or VSE), Acinetobacter spp., Pseudomonas spp., and Enterobacteriaceae of interest such as E. coli and Klebsiella spp.
Measured: At the end of a 12-hour ICU shift
The proportion of positive cultures - overall and at each culture location
Measured: At the end of three 12-hour ICU shifts
The number of suspected and confirmed "transmission events"
Measured: At the end of three 12-hour ICU shifts
The proportion of suspected and confirmed "transmission events"
Measured: At the end of three 12-hour ICU shifts
Health care personnel perceptions of clothing as measured by survey
Measured: At the end of a 12-hour ICU shift
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disease TransmissionStudies of the same condition, open and under way.
- More trials run by Duke 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deverick Anderson, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645214
- Sponsor's protocol ID
- Pro00062781
- Acronym
- ASCOT
- Status last verified
- Mar 2016
- First submitted
- 31 Dec 2015
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Anderson DJ, Addison R, Lokhnygina Y, Warren B, Sharma-Kuinkel B, Rojas LJ, Rudin SD, Lewis SS, Moehring RW, Weber DJ, Rutala WA, Bonomo RA, Fowler VG, Sexton DJ; CDC Prevention Epicenters Program. The Antimicrobial Scrub Contamination and Transmission (ASCOT) Trial: A Three-Arm, Blinded, Randomized Controlled Trial With Crossover Design to Determine the Efficacy of Antimicrobial-Impregnated Scrubs in Preventing Healthcare Provider Contamination. Infect Control Hosp Epidemiol. 2017 Oct;38(10):1147-1154. doi: 10.1017/ice.2017.181. Epub 2017 Aug 29.
PubMed 28847326
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiseptic Scrub Contamination and Transmission Trial: A Randomized Controlled Trial to Evaluate the Impact of Antiseptic Scrubs on Bacterial Contamination.
- ClinicalTrials.gov ID
- NCT02645214
- Acronym / sponsor ID
- ASCOT / Pro00062781
- Conditions
- Disease Transmission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Jan 2016 (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 is a prospective, blinded, randomized, controlled trial (RCT) with a crossover design to determine if antiseptic-impregnated surgical scrubs decrease the burden of healthcare providers (HCP) clothing contamination compared to standard, control surgical scrubs following a 12-hour ICU shift.
Detailed description
The investigators will perform a 3-arm prospective, blinded, randomized, controlled trial with a cross-over design to determine if HCP who wear antiseptic-impregnated clothing (i.e., surgical scrubs) will acquire and transmit fewer pathogens than HCP wearing standard clothing.
A total of 40 intensive care unit (ICU) nurses (from the Medical and Surgical ICUs in the Duke Medical Pavilion) will be enrolled and sign a consent form to participate in the study. Their main task will be to wear control (non- antiseptic) scrubs (Arm 1) and two different types of antiseptic-impregnated scrubs (Arms 2 and 3). Subjects will be randomized to one of 6 strategies. Each nurse typically cares for two patients each day and will be enrolled for three consecutive days (or shifts, if they do not work for 3 days in a row). Once the nurses have consented to participate in this project, the study coordinator will provide the 3 sets of scrubs and will label them with numbers, thus blinding the nurses to which scrubs they will wear on which day. The nurse will wear the scrubs on the 3 pre-arranged shifts.
Data will be summarized using standard statistical methods. The investigators will utilize linear mixed models to compare relative differences in the amount of contamination between arms at the end of the shift to adjust for our crossover study design. Mixed effects logistic regression models will be used to compare proportions. All calculations will be adjusted for the amount of environmental contamination observed during the shift and contamination on HCP clothing in the beginning of the shift. Statistical significance for two primary comparisons (each antiseptic scrub versus control) will be corrected for multiple comparisons.
This is a minimal risk study and the investigators have no safety concerns from the patients or nurses as relates to obtaining swabs and room cultures, nor with wearing the scrubs and having them cultured. Data will be stored on encrypted Duke Medicine servers (participant log \& study IDs) and/or in our REDCap database (all other data collected for the study).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control scrubs (non-antiseptic) | Placebo comparator | Other: Non-antiseptic scrubssubject will wear control scrubs for the duration of a 12-hour ICU shift |
| Antiseptic Impregnated Scrubs Type 1 | Active comparator | Other: Antiseptic scrubssubject will wear antiseptic impregnated scrubs-type 1 for the duration of a 12-hour ICU shift |
| Antiseptic Impregnated Scrubs Type 2 | Active comparator | Other: Antiseptic scrubssubject will wear antiseptic impregnated scrubs-type 2 for the duration of a 12-hour ICU shift |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All intensive care unit (ICU) nurses at Duke Medical Center are eligible to participate in this study.
Key exclusion criteria (1 listed)
- Nurses outside the Duke Medical Center ICU will not be eligible to participate in this study.
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 |
|---|---|---|
| Non-antiseptic scrubs | Other | Control scrubs (non-antiseptic) |
| Antiseptic scrubs | Other | Antiseptic Impregnated Scrubs Type 1, Antiseptic Impregnated Scrubs Type 2 |
Primary outcome
The difference in total acquired contamination (Total CFU) on HCP clothing at the end of a 12-hour ICU shift.
Time frame: At the end of a 12-hour ICU shift
5 secondary outcomes
The presence or absence of individual specific pathogens: S. aureus (MRSA or MSSA), Enterococci (VRE or VSE), Acinetobacter spp., Pseudomonas spp., and Enterobacteriaceae of interest such as E. coli and Klebsiella spp.
Time frame: At the end of a 12-hour ICU shift
The proportion of positive cultures - overall and at each culture location
Time frame: At the end of three 12-hour ICU shifts
The number of suspected and confirmed "transmission events"
Time frame: At the end of three 12-hour ICU shifts
The proportion of suspected and confirmed "transmission events"
Time frame: At the end of three 12-hour ICU shifts
Health care personnel perceptions of clothing as measured by survey
Time frame: At the end of a 12-hour ICU 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 14 Feb 2017.
- Derived from this study: PubMed 28847326Anderson DJ, Addison R, Lokhnygina Y, Warren B, Sharma-Kuinkel B, Rojas LJ, Rudin SD, Lewis SS, Moehring RW, Weber DJ, Rutala WA, Bonomo RA, Fowler VG, Sexton DJ; CDC Prevention Epicenters Program. The Antimicrobial Scrub Contamination and Transmission (ASCOT) Trial: A Three-Arm, Blinded, Randomized Controlled Trial With Crossover Design to Determine the Efficacy of Antimicrobial-Impregnated Scrubs in Preventing Healthcare Provider Contamination. Infect Control Hosp Epidemiol. 2017 Oct;38(10):1147-1154. doi: 10.1017/ice.2017.181. Epub 2017 Aug 29.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
Deverick Anderson, MD, MPH principal investigator
Duke 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 Non-antiseptic scrubs and Antiseptic scrubs in people with Disease Transmission, run by Duke 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 14 Feb 2017. 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. 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?
The difference in total acquired contamination (Total CFU) on HCP clothing at the end of a 12-hour ICU shift. (time frame: At the end of a 12-hour ICU shift). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02645214, which also lists 1 linked publication.
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 14 Feb 2017.