Theraworx Bath Wipes Versus Standard Bath Wipes in the Reduction of Vancomycin-Resistant Enterococci
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any - 21 |
| Updated: | 10/8/2017 |
| Start Date: | October 30, 2014 |
| End Date: | September 19, 2017 |
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
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.
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.
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.
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.
Inclusion Criteria:
- Less than or equal to 21 years of age.
- Scheduled to undergo either autologous or allogeneic hematopoietic stem cell
transplant
Exclusion Criteria:
- 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
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Margie Kjellin, RN
Phone: 866-278-5833
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