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

Completed · Not applicable

Conditions studied: Hematopoietic Stem Cell Transplantation, Vancomycin-Resistant Enterococci

In brief

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.

Key facts

Study ID

NCT02241005

Run by

St. Jude Children's Research Hospital

People needed

159

Starts

2014-10-30

Expected to finish

2017-09-19

Last updated by the study team

2017-10-06

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Less than or equal to 21 years of age.
• Scheduled to undergo either autologous or allogeneic hematopoietic stem cell transplant

You may not qualify if…

• Participant/Parent/Legally authorized representative (LAR) unwilling to give written informed consent.
• (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted within 14 days prior to enrollment).
• (Female only) Breast feeding

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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