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

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.

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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