TWIPES: Bath Wipes in Reducing Skin Bacteria in Younger Patients Undergoing Stem Cell Transplant

A Pilot Study of the Safety Followed by a Randomized Controlled Trial of the Efficacy of Non-Antimicrobial 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

Category:

TWIPES

Eligibility Overview:

This is a non-therapeutic clinical trial that is only open to St. Jude patients.

This clinical trial has inclusion and exclusion criteria. See full trial for specifics.

Description

Daily baths are essential in protecting the skin against microorganisms (bacteria, viruses, fungi) that can cause infection. Lowering the number of these microbes on the skin could lower the risk of contamination of central venous catheters and bacteremia (bacteria in the blood) due to compromise of skin integrity. A bath with disposable wipes is the primary way transplant patients at St. Jude bathe. Researchers want to study whether a new experimental bath wipe with different ingredients works better than the bath wipes that are regularly used in helping to prevent infections.

Objectives

  • To determine if the experimental bath wipes are safe and well tolerated for daily bathing.
  • To study how many participants have their skin colonized with bacteria, including vancomycin-resistant enterococci (VRE).
  • To compare the incidence of multi-drug resistant organisms (MRDO) skin colonization and central line associated blood stream infection rates.
  • To compare the incidence of skin graft versus host disease (GVHD).
  • To describe patient and parent satisfaction with the bath wipes.

Eligibility

Inclusion Criteria

  • Participant is less than or equal to 21 years of age.
  • Participant is undergoing an autologous or allogeneic stem cell transplant.
  • Participant/Parent/Legal guardian is willing to sign informed consent.

Exclusion Criteria

  • Participant is pregnant.
  • Participant is breast feeding.

Principal Investigator

Marjorie Kjellin, RN

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.