- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02348866
Bacterial Contamination on Obstetric Resident Surgical Scrubs
January 13, 2016 updated by: Prisma Health-Upstate
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ob-gyn residents assigned to labor and delivery during the day on one of seven rotation blocks
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1
home laundered/home-donned
|
|
|
Active Comparator: Group 2
Hospital laundered/home-donned
|
|
|
Active Comparator: Group 3
Home laundered/hospital donned
|
|
|
Active Comparator: Group 4
Hospital laundered/hospital donned
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of antibiotic resistant Staphylococcus aureus on surgical scrubs in the obstetric setting
Time Frame: 4 days
|
4 days of randomization per subject
|
4 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kacey Y Eichelberger, MD, Prisma Health-Upstate
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
January 23, 2015
First Submitted That Met QC Criteria
January 27, 2015
First Posted (Estimate)
January 28, 2015
Study Record Updates
Last Update Posted (Estimate)
January 14, 2016
Last Update Submitted That Met QC Criteria
January 13, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- Pro#00041187
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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