NCT02348866

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

January 23, 2015

Last Update Submit

January 13, 2016

Conditions

Bacterial Contamination

Outcome Measures

Primary Outcomes (1)

  • 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

    4 days

Secondary Outcomes (1)

  • Prevalence of antibiotic resistant Staphylococcus aureus on surgical scrubs in the obstetric setting

    4 days

Study Arms (4)

Group 1

ACTIVE COMPARATOR

home laundered/home-donned

Other: method of laundering and donning scrubs

Group 2

ACTIVE COMPARATOR

Hospital laundered/home-donned

Other: method of laundering and donning scrubs

Group 3

ACTIVE COMPARATOR

Home laundered/hospital donned

Other: method of laundering and donning scrubs

Group 4

ACTIVE COMPARATOR

Hospital laundered/hospital donned

Other: method of laundering and donning scrubs

Interventions

method of laundering and donning scrubsOTHER
Group 1Group 2Group 3Group 4

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ob-gyn residents assigned to labor and delivery during the day on one of seven rotation blocks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Kacey Y Eichelberger, MD

    Prisma Health-Upstate

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2015

First Posted

January 28, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2015

Study Completion

January 1, 2016

Last Updated

January 14, 2016

Record last verified: 2016-01