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NCT02241005 · ClinicalTrials.gov registry record · NA

Theraworx Bath Wipes Versus Standard Bath Wipes in the Reduction of Vancomycin-Resistant Enterococci

A NA study, sponsored by St. Jude Children's Research Hospital.

Completed
Registry status
NA
Development phase
159
Enrollment target

NCT02241005 is a NA study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 159 participants.

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The verdict

NCT02241005, a NA study, has completed, sponsored by St. Jude Children's Research Hospital.

COMPLETED
Registry status
NA
Development phase
159 participants
Enrollment target

Study Summary

Healthcare-associated infections (HAI) are associated with substantial morbidity, mortality and health-care costs in children undergoing hematopoietic stem cell transplantation (HSCT). These infections are often caused by a patient's own microbial flora. Hence reduction of microbes in the skin could lessen the risk of contamination of central venous catheters, Central Line Associated Blood-Stream Infections (CLABSI), and bacteremia due to compromise of skin integrity. Theraworx™ (herein referred to as experimental wipes) is a self-drying, leave on cleansing agent that combines a specialized surfactant with skin healthy ingredients, including aloe, allantoin, vitamin E, and silver, which is the main antimicrobial ingredient. It can be used on all parts of the body including burns, abraded skin, and on patients with skin graft-versus-host-disease (GVHD). It is user friendly and obviates the risk of antimicrobial resistance. Microbiologic studies have shown several log fold reduction of bacteria including vancomycin-resistant enterococci, carbapenem resistant Escherichia coli, and activity against Staphylococcus aureus, Enterococcus faecalis, Clostridium difficile, Candida albicans, and viruses including influenza A and Herpes Simplex. There is no data regarding the use of Theraworx™ (experimental) bath wipes in children or the HSCT population. Researchers at St. Jude Children's Research Hospital want to learn if daily bathing with experimental bath wipes will be well tolerated and associated with reduction in microbial skin colonization in this population.

Interventions

  • OTHER Theraworx™ bath wipes
  • OTHER Standard bath wipes

Trial Details

FieldValue
Enrollment Target 159 participants
Start Date 2014-10-30
Est. Completion 2017-09-19
Phase NA

What the Registry Record Tells You About NCT02241005

The ClinicalTrials.gov registry entry for NCT02241005 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 159 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Theraworx™ bath wipes is the first listed.

NCT02241005 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02241005 about?

NCT02241005 is a clinical study titled "Theraworx Bath Wipes Versus Standard Bath Wipes in the Reduction of Vancomycin-Resistant Enterococci". Healthcare-associated infections (HAI) are associated with substantial morbidity, mortality and health-care costs in children undergoing hematopoietic stem cell transplantation (HSCT). These infections are often caused by a patient's own microbial flora. Hence reduction of microbes in the skin could...

What is the current status of trial NCT02241005?

This trial is currently completed. It is a NA study. The enrollment target is 159 participants. The study started on 2014-10-30. Estimated completion is 2017-09-19.

What interventions are being tested in trial NCT02241005?

The interventions under investigation include: Theraworx™ bath wipes (OTHER), Standard bath wipes (OTHER).

Who is sponsoring clinical trial NCT02241005?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.