Avoiding Bacterial Contamination of Clean Catch Urine Cultures in Ambulatory Patients in the Emergency Department

NCT03131609 | Completed

• 1 other identifier: 33879
• Study Type: observational
• Target: 1,471
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find the best cleaning and collection methods to obtain a 'non-contaminated' clean catch mid-stream urine sample to diagnose suspected urinary tract infection (UTI).

Conditions

Urinary Tract Infections; Bacteriuria; Urinalysis

Outcome Measures

Primary Outcomes (1)

• Decrease in the number of contaminated urine cultures

  Contamination \>10,000 CFU/mL mixed flora identified by Clinical Laboratory

  9 months

Study Arms (4)

A: Container + Castile-soap wipe

Sterile urine collection container and Castile-soap wipe given to patient to self-obtain a clean catch mid-stream urine specimen - Control group represents usual care in the Emergency Department.

Other: Container; Other: Castile-soap wipe

B: Container + Silver impregnated wipe

Sterile urine collection container and silver-impregnated cloth-wipe given to patient to self-obtain a clean catch mid-stream urine specimen

Other: Container; Other: Silver Impregnated Wipe

C: Funnel + Castile-soap wipe

Sterile urine collection funnel and Castile-soap wipe given to patient to self-obtain a clean catch mid-stream urine specimen

Other: Funnel; Other: Castile-soap wipe

D: Funnel + Silver-impregnated wipe

Urine collection funnel and sliver impregnated cloth-wipe given to patient to self-obtain a clean catch mid-stream urine specimen

Other: Silver Impregnated Wipe; Other: Funnel

Interventions

Container OTHER

Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.

Also known as: Standard container for urine collection

A: Container + Castile-soap wipe; B: Container + Silver impregnated wipe

Silver Impregnated Wipe OTHER

Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.

Also known as: Theraworx

B: Container + Silver impregnated wipe; D: Funnel + Silver-impregnated wipe

Funnel OTHER

Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.

Also known as: Peezy Mid-stream urine collection kit

C: Funnel + Castile-soap wipe; D: Funnel + Silver-impregnated wipe

Castile-soap wipe OTHER

Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.

A: Container + Castile-soap wipe; C: Funnel + Castile-soap wipe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ambulatory patients in the Emergency Department at an Academic Medical Center with a physician order for a urine culture. Patient must be able to self-obtain the urine culture.

You may qualify if:

• years of older
• Urine culture order by physician

You may not qualify if:

• Under 18 years of age
• Urinary catheter in place
• Not ambulatory

Sponsors & Collaborators

• Stanford University: lead
• EBLEN Charities: collaborator
• Forte Medical Ltd.: collaborator
• Avadim Technologies, Inc.: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• Lough ME, Shradar E, Hsieh C, Hedlin H. Contamination in Adult Midstream Clean-Catch Urine Cultures in the Emergency Department: A Randomized Controlled Trial. J Emerg Nurs. 2019 Sep;45(5):488-501. doi: 10.1016/j.jen.2019.06.001.

  PMID: 31445626 RESULT

MeSH Terms

Conditions

Urinary Tract Infections; Bacteriuria

Interventions

Urine Specimen Collection; FTX, spider toxin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Mary E. Lough, PhD, RN

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 27, 2017
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)