Hematopoietic Stem Cell TransplantationNCT02241005
Theraworx Bath Wipes Versus Standard Bath Wipes in the Reduction of Vancomycin-Resistant Enterococci
A study testing Theraworx™ bath wipes and Standard bath wipes in people with Hematopoietic Stem Cell Transplantation and Vancomycin-Resistant Enterococci, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation, Vancomycin-Resistant Enterococci
- What is being tested?
- Theraworx™ bath wipes and Standard bath wipes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2014to 19 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Less than or equal to 21 years of age.
- Scheduled to undergo either autologous or allogeneic hematopoietic stem cell transplant
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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
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.
Read the 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.
- Being tested
- Theraworx™ bath wipes, Standard bath wipes
- Keywords
- Health-care associated infection, Skin integrity, Antimicrobial resistance
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theraworx™ bath wipesOther
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 wipesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Theraworx™ | Active comparator | Participants are randomized to use the Theraworx™ bath wipes. Receives: Other: Theraworx™ bath wipes |
| Standard | Active comparator | Participants are randomized to use standard bath wipes. Receives: Other: Standard bath wipes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Summary statistics for the number of different bacterial species in groups of patients using the experimental and standard bath wipes will be provided. Exact Wilcoxon rank sum test will be used to compare the medians of the numbers of different bacterial species in two groups.
Measured: 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)
The proportions of patients with MRDO and CLABSI in the groups of patients using the experimental wipes and standard bath wipes and their 95% Blyth-Still-Casella (BSC) CIs will be provided. Fisher's exact test will be used to test for the null hypothesis that two proportions are equal.
Measured: At enrollment, at the time of initial discharge from the inpatient unit, and at end of study (60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study start30 Oct 2014
- Primary completion19 Sep 2017
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Avadim Technologies, Inc.
- Responsible party
- Sponsor
- Investigators
- Margie Kjellin, RN, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241005
- Sponsor's protocol ID
- TWIPES
- Other IDs
- NCI-2015-00114
- Status last verified
- Oct 2017
- First submitted
- 12 Sep 2014
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02241005
- Acronym / sponsor ID
- TWIPES
- Keywords
- Health-care associated infection, Skin integrity, Antimicrobial resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- Avadim Technologies, Inc.
- Study start
- 30 Oct 2014 (actual)
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theraworx™ | Active comparator | Other: Theraworx™ bath wipesParticipants are randomized to use the Theraworx™ bath wipes. |
| Standard | Active comparator | Other: Standard bath wipesParticipants are randomized to use standard bath wipes. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Less than or equal to 21 years of age.
- Scheduled to undergo either autologous or allogeneic hematopoietic stem cell transplant
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theraworx™ bath wipesTheraworx™ 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. | Other | Theraworx™ |
| Standard bath wipesStandard 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. | Other | Standard |
Primary outcome
Proportion of patients using Theraworx™ wipes who experience any grade IV skin toxicity
Time frame: Through date of discharge from inpatient unit, or maximum of 60 days after study enrollment
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.
Proportion of patients with vancomycin-resistant enterococci (VRE) colonization by study arm
Time frame: At enrollment, at the time of initial discharge from the inpatient unit, and at end of study (60 days)
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
2 secondary outcomes
Number of different bacterial species in participants by study arm
Time frame: 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)
Time frame: At enrollment, at the time of initial discharge from the inpatient unit, and at end of study (60 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margie Kjellin, RN principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theraworx™ bath wipes and Standard bath wipes in people with Hematopoietic Stem Cell Transplantation and Vancomycin-Resistant Enterococci, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients using Theraworx™ wipes who experience any grade IV skin toxicity (time frame: Through date of discharge from inpatient unit, or maximum of 60 days after study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.