Theraworx Bath Wipes Versus Standard Bath Wipes in the Reduction of Vancomycin-Resistant Enterococci
A Randomized Controlled Trial of the Safety and Efficacy of Theraworx Bath Wipes in the Reduction of Skin Colonization With Vancomycin-Resistant Enterococci Compared to Standard Bath Wipes in Children Undergoing Hematopoietic Stem Cell Transplantation
Other study identifiers
Sponsor study identifier
Secondary identifiers
REGISTRY · NCI Clinical Trial Registration Program
interventional
159
1 country
1
Study Start
October 30, 2014
Actual (reported)Primary Completion
September 19, 2017
Actual (reported)Study Completion
September 19, 2017
Actual (reported)Brief 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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 159 participants
- Study completion date
September 19, 2017
Actual (reported)- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
September 12, 2014
Actual (reported)First Posted
September 16, 2014
Actual (reported)Study Start
October 30, 2014
Actual (reported)Primary Completion
September 19, 2017
Actual (reported)Study Completion
September 19, 2017
Actual (reported)
- Last Updated
- October 6, 2017
- Status Verified
- October 2017
- Last Update Submitted
- October 5, 2017