Bacterial ContaminationNCT02348866
Bacterial Contamination on Obstetric Resident Surgical Scrubs
A study testing method of laundering and donning scrubs in people with Bacterial Contamination, run by Prisma Health-Upstate.
Trial summary
This study will determine if there is a difference in bacterial contamination (CFU/cm2) between obstetric resident surgical scrubs donned at home and those donned at the hospital. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bacterial Contamination
- What is being tested?
- method of laundering and donning scrubs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jan 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ob-gyn residents assigned to labor and delivery during the day on one of seven rotation blocks
Who cannot join
- -
About this study
Official title: Bacterial Contamination on Obstetric Resident Surgical Scrubs: a Randomized Trial
This study will determine if there is a difference in bacterial contamination (CFU/cm2) between obstetric resident surgical scrubs donned at home and those donned at the hospital.
Read the detailed description
An area of potential provider-to-patient contamination, and therefore intervention, is in health care worker attire and laundering practices. For providers who work in the operating room or labor \& delivery suites, this uniform usually comprises hospital-issued surgical scrubs. To the best of our knowledge, no study has measured the difference in bacterial contamination on surgical scrubs vis-a-vis the two variables most directly affected by hospital policies for surgical attire: site of scrub laundering and site where scrubs were first put on. In addition, no study has measured the prevalence of antibiotic-resistant organisms on surgical scrubs in the obstetric setting. Our primary objective is to measure the difference in bacterial contamination (CFU/cm2) between home-laundered/home-donned scrubs ("home/home," group 1), hospital-laundered/home-donned scrubs ("hospital/home," group 2), home-laundered/hospital-donned scrubs ("home/hospital," group 3), and hospital-laundered/hospital-donned scrubs ("hospital/hospital," group 4) in the obstetric setting. Our secondary objective is to determine the prevalence of antibiotic-resistant organisms on surgical scrubs in the obstetric setting.
- Conditions
- Bacterial Contamination
- Being tested
- method of laundering and donning scrubs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
method of laundering and donning scrubsOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | home laundered/home-donned Receives: Other: method of laundering and donning scrubs |
| Group 2 | Active comparator | Hospital laundered/home-donned Receives: Other: method of laundering and donning scrubs |
| Group 3 | Active comparator | Home laundered/hospital donned Receives: Other: method of laundering and donning scrubs |
| Group 4 | Active comparator | Hospital laundered/hospital donned Receives: Other: method of laundering and donning scrubs |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in bacterial contamination between scrubs donned at home and those put on in the hospital, when location of laundering is considered (as determined by (CFU/cm2)
4 days of randomization per subject
Measured: 4 days
Secondary outcomes (1)
Prevalence of antibiotic resistant Staphylococcus aureus on surgical scrubs in the obstetric setting
4 days of randomization per subject
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionJan 2016
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kacey Y Eichelberger, MD, Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348866
- Sponsor's protocol ID
- Pro#00041187
- Status last verified
- Jan 2016
- First submitted
- 23 Jan 2015
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Contamination on Obstetric Resident Surgical Scrubs: a Randomized Trial
- ClinicalTrials.gov ID
- NCT02348866
- Acronym / sponsor ID
- Pro#00041187
- Conditions
- Bacterial Contamination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Jan 2015 (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 determine if there is a difference in bacterial contamination (CFU/cm2) between obstetric resident surgical scrubs donned at home and those donned at the hospital.
Detailed description
An area of potential provider-to-patient contamination, and therefore intervention, is in health care worker attire and laundering practices. For providers who work in the operating room or labor \& delivery suites, this uniform usually comprises hospital-issued surgical scrubs. To the best of our knowledge, no study has measured the difference in bacterial contamination on surgical scrubs vis-a-vis the two variables most directly affected by hospital policies for surgical attire: site of scrub laundering and site where scrubs were first put on. In addition, no study has measured the prevalence of antibiotic-resistant organisms on surgical scrubs in the obstetric setting. Our primary objective is to measure the difference in bacterial contamination (CFU/cm2) between home-laundered/home-donned scrubs ("home/home," group 1), hospital-laundered/home-donned scrubs ("hospital/home," group 2), home-laundered/hospital-donned scrubs ("home/hospital," group 3), and hospital-laundered/hospital-donned scrubs ("hospital/hospital," group 4) in the obstetric setting. Our secondary objective is to determine the prevalence of antibiotic-resistant organisms on surgical scrubs in the obstetric setting.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: method of laundering and donning scrubshome laundered/home-donned |
| Group 2 | Active comparator | Other: method of laundering and donning scrubsHospital laundered/home-donned |
| Group 3 | Active comparator | Other: method of laundering and donning scrubsHome laundered/hospital donned |
| Group 4 | Active comparator | Other: method of laundering and donning scrubsHospital laundered/hospital donned |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ob-gyn residents assigned to labor and delivery during the day on one of seven rotation blocks
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| method of laundering and donning scrubs | Other | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
difference in bacterial contamination between scrubs donned at home and those put on in the hospital, when location of laundering is considered (as determined by (CFU/cm2)
Time frame: 4 days
4 days of randomization per subject
1 secondary outcome
Prevalence of antibiotic resistant Staphylococcus aureus on surgical scrubs in the obstetric setting
Time frame: 4 days
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 Jan 2016.
Related trials for Bacterial Contamination
Not yet recruiting
Bacterial Mask Contamination in Operating Room
Bacterial Contamination
Not yet recruitingPhase 4
Effectiveness of Pre-Procedural CPC and Zinc Mouthwash in Reducing Dental Aerosols
Bacterial Contamination
RecruitingObservational study
Impact of Blood Cultures Drawn From Arterial Lines on the Incidence of Contamination, Detection of Bacteremia, and Blood Culture Volume
Bacteremia
Active, not recruiting
Blood Culture Collection Strategies for Suspected Bloodstream Infection
Bacteremia and Sepsis, Bloodstream Infection
Not yet recruitingPhase 4
Investigation of the PREVENTIA® Irrigation Solution for Reducing Bacteria in Spinal Surgery With Implants - A Comparative Study
Surgical Site Infection (SSI), Spine Surgery
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.
Kacey Y Eichelberger, MD principal investigator
Prisma Health-Upstate
Questions about this trial
What is this clinical trial studying?
A study testing method of laundering and donning scrubs in people with Bacterial Contamination, run by Prisma Health-Upstate.
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 Jan 2016. 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. 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?
difference in bacterial contamination between scrubs donned at home and those put on in the hospital, when location of laundering is considered (as determined by (CFU/cm2) (time frame: 4 days). 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 14 Jan 2016.