Allogeneic Hematopoietic Cell Transplantation
Conditions
Brief summary
The central hypothesis is that daily dental xylitol wipes, in addition to current oral care practice, are effective at reducing BSI from oral organisms, and decreasing the incidence of gingivitis, oral plaque, and oral ulcerations after SCT.
Detailed description
Our long-term goal is to develop and disseminate clinically relevant, and easily adoptable strategies to prevent BSI and improve outcomes after SCT. The overall objective of this proposal is to identify a clinically effective strategy to prevent or reduce BSI secondary to bacterial translocation through oral injured mucosa .
Interventions
DRUGXylitol
Xylitol dental wipes
OTHERPlacebo
Placebo dental wipes
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
1:1, randomized, double-blind, placebo-controlled study
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients of any age undergoing SCT.
Exclusion criteria
* Prior proton or photon radiation treatment for cancer of the oral cavity, head or neck; cranial boost in patients receiving total body irradiation; known history of allergy to xylitol; inability to use a mouth rinse or dental wipes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of bacteremia in the first 30 days post-HSCT with oral organisms | 30 days |
| Incidence of bacteremia in the first 30 days post-HSCT with any organism | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of oral microbiome diversity | 30 days |
| Incidence of oral pathogenic bacteria burden | 30 days |
| Incidence of mucosal ulceration | 30 days |
| Incidence of gingival inflammation | 30 days |
| Incidence of dental plaque | 30 days |
| Incidence of oral mucositis | 30 days |
Countries
United States
Outcome results
None listed