Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-21 @ 12:39 PM
Study NCT ID:
NCT02241005
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
2014-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Theraworx Bath Wipes Versus Standard Bath Wipes in the Reduction of Vancomycin-Resistant Enterococci
Sponsor:
St. Jude Children's Research Hospital
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
Participants will be randomized to receive either a daily bath with the experimental bath wipes, or the standard bath wipes, beginning on the day of admission, and to be used once daily for a period of 60 days post-HSCT. In the first 12 patients randomized to the experimental wipes, if no patient has grade IV skin toxicity that is attributable to the experimental wipes, then the trial will continue until a total of 250 evaluable participants have been enrolled. Assessment of skin colonization will be performed before admission, at the time of discharge, and post-HSCT.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2015-00114 | REGISTRY | NCI Clinical Trial Registration Program | View |