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

NCT02241005 | Completed

• 2 other identifiers: TWIPESNCI-2015-00114
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Stem Cell Transplantation; Vancomycin-Resistant Enterococci

Keywords

Health-care associated infection; Skin integrity; Antimicrobial resistance

Outcome Measures

Primary Outcomes (2)

• Proportion of patients using Theraworx™ wipes who experience any grade IV skin toxicity

  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 study will be stopped and the use of experimental bath wipes for HSCT patients will be considered unsafe. If the use of experimental bath wipes for HSCT patients is considered feasible, the trial will continue. 95% Blyth-Still-Casella will be provided.

  Through date of discharge from inpatient unit, or maximum of 60 days after study enrollment

• Proportion of patients with vancomycin-resistant enterococci (VRE) colonization by study arm

  The proportion of patients with VRE colonization at enrollment and at the time of initial discharge from the inpatient unit in the groups of patients using the experimental and standard bath wipes and their 95% confidence intervals (CI) will be provided. Fisher's exact test will be used to test for the null hypothesis that two proportions are equal

  At enrollment, at the time of initial discharge from the inpatient unit, and at end of study (60 days)

Secondary Outcomes (2)

• Number of different bacterial species in participants by study arm

  At enrollment, at the time of initial discharge from the inpatient unit, and at end of study (60 days)

• Proportion of patients with multi-drug resistant organisms (MRDO) and central line-associated bloodstream infection (CLABSI)

  At enrollment, at the time of initial discharge from the inpatient unit, and at end of study (60 days)

Study Arms (2)

Theraworx™

ACTIVE COMPARATOR

Participants are randomized to use the Theraworx™ bath wipes.

Other: Theraworx™ bath wipes

Standard

ACTIVE COMPARATOR

Participants are randomized to use standard bath wipes.

Other: Standard bath wipes

Interventions

Theraworx™ bath wipes OTHER

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.

Theraworx™

Standard bath wipes OTHER

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.

Standard

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• Avadim Technologies, Inc.: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Margie Kjellin, RN

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2014
• First Posted: September 16, 2014
• Study Start: October 30, 2014
• Primary Completion: September 19, 2017
• Study Completion: September 19, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

US (1)