Stem Cell Transplant Complications
Conditions
Brief summary
This study evaluates the use of 2% CHG washcloths in an outpatient setting for adults after hematopoietic stem cell transplant in prevention of central line associated blood stream infections. Half of the participants will use 2% CHG washcloths and other half will use placebo washcloths.
Interventions
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Admitted to the University of Chicago Hematopoietic Stem Cell Transplant Unit for transplant * Age 18 and up
Exclusion criteria
* Experienced an allergy or rash related to use of chlorhexidine washcloths or other chlorhexidine products * Extensive open wounds
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Primary Blood Stream Infections | 14 weeks | Blood stream infections are defined by the presence of bacteria in the blood |
| Number of Participants With Clinical (Culture-negative) Sepsis | 14 weeks | Clinical (culture-negative) sepsis is defined by the presence of low blood pressure without bacteria in the blood |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chlorhexidine Gluconate 2% Wipe Chlorhexidine Gluconate 2% Wipe | 21 |
| Placebo Wipe Placebo Wipe | 29 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Fatigue/Overwhelmed | 1 | 5 |
| Overall Study | Fever | 2 | 2 |
| Overall Study | Line Removed | 0 | 2 |
| Overall Study | No longer interested | 5 | 3 |
| Overall Study | Positive Blood Cultures | 2 | 1 |
| Overall Study | Rash | 2 | 1 |
Baseline characteristics
| Characteristic | Chlorhexidine Gluconate 2% Wipe | Total | Placebo Wipe |
|---|---|---|---|
| Age, Continuous | 63 years | 61.5 years | 61 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 49 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 12 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 37 Participants | 23 Participants |
| Region of Enrollment United States | 21 participants | 50 participants | 29 participants |
| Sex: Female, Male Female | 10 Participants | 23 Participants | 13 Participants |
| Sex: Female, Male Male | 11 Participants | 27 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 29 |
| other Total, other adverse events | 2 / 21 | 1 / 29 |
| serious Total, serious adverse events | 0 / 21 | 0 / 29 |
Outcome results
Primary
Number of Participants With Clinical (Culture-negative) Sepsis
Clinical (culture-negative) sepsis is defined by the presence of low blood pressure without bacteria in the blood
Time frame: 14 weeks
Population: Among all subjects enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlorhexidine Gluconate 2% Wipe | Number of Participants With Clinical (Culture-negative) Sepsis | 0 Participants |
| Placebo Wipe | Number of Participants With Clinical (Culture-negative) Sepsis | 0 Participants |
Primary
Number of Participants With Primary Blood Stream Infections
Blood stream infections are defined by the presence of bacteria in the blood
Time frame: 14 weeks
Population: Among all subjects enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Chlorhexidine Gluconate 2% Wipe | Number of Participants With Primary Blood Stream Infections | 1 Participants |
| Placebo Wipe | Number of Participants With Primary Blood Stream Infections | 2 Participants |