Theraworx Bath Wipes Versus Standard Bath Wipes in the Reduction of Vancomycin-Resistant Enterococci
NCT ID: NCT02241005
Last Updated: 2017-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
159 participants
INTERVENTIONAL
2014-10-30
2017-09-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Randomization will take place at the time the participant is enrolled and will be performed by staff within the Nursing Research Department. Participants will be assigned to either experimental or standard bath wipes in a 1:1 ratio. Randomization may be stratified for nature of transplant (autologous vs. allogeneic); and in the case of allogeneic transplant stratified for total body irradiation vs. no total body irradiation. The investigators, practicing clinician and the clinical research staff will remain blinded to the treatment.
PRIMARY OBJECTIVES:
* Assess the safety of the experimental bath wipes in 12 patients.
* Assess the skin colonization with vancomycin-resistant enterococci in patients using the experimental wipes compared to standard bath wipes.
SECONDARY OBJECTIVES:
* Assess skin colonization with bacterial pathogens.
* Compare the skin colonization with multi-drug resistant organisms (MRDO) and central line-associated bloodstream infection (CLABSI) rates.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Theraworx™
Participants are randomized to use the Theraworx™ bath wipes.
Theraworx™ bath wipes
Theraworx™ bath wipes will be supplied in packaging similar to the standard bath wipes used in this study. The bath wipes will be started on the day of admission, and used once daily for a period of 60 days post-HSCT.
Standard
Participants are randomized to use standard bath wipes.
Standard bath wipes
Standard bath wipes will be supplied in packaging similar to the Theraworx™ bath wipes used in this study. The bath wipes will be started on the day of admission, and used once daily for a period of 60 days post-HSCT.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Theraworx™ bath wipes
Theraworx™ bath wipes will be supplied in packaging similar to the standard bath wipes used in this study. The bath wipes will be started on the day of admission, and used once daily for a period of 60 days post-HSCT.
Standard bath wipes
Standard bath wipes will be supplied in packaging similar to the Theraworx™ bath wipes used in this study. The bath wipes will be started on the day of admission, and used once daily for a period of 60 days post-HSCT.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Scheduled to undergo either autologous or allogeneic hematopoietic stem cell transplant
Exclusion Criteria
* (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted within 14 days prior to enrollment).
* (Female only) Breast feeding
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Avadim Technologies, Inc.
INDUSTRY
St. Jude Children's Research Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Margie Kjellin, RN
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2015-00114
Identifier Type: REGISTRY
Identifier Source: secondary_id
TWIPES
Identifier Type: -
Identifier Source: org_study_id