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

NCT02241005 is a NA study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 159 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

In the first 12 evaluable patients in the Theraworx™ arm of the randomized controlled trial, we will closely monitor for the safety of experimental bath wipes. Since no grade IV toxicity attributable to the wipes is expected in the standard bath wipes arm, if at any time during the study in the first 12 evaluable participants in the experimental arm we observe one patient with grade IV skin rash toxicity in the experimental arm which is attributable to the experimental bath wipes , then the stud

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 finished NCT02241005 record still lists

NCT02241005 is an interventional study that assigns participants to a tested intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).

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

NCT02241005 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02241005's enrollment target sits among peer trials

159 654th of 2000 higher than 1,347 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02241005, the US trial registry maintained by the National Library of Medicine. NCT02241005 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.