Bacteremia
Conditions
Keywords
Bacteremia, Blood culture, Contamination, Antiseptic agents
Brief summary
Background: Contaminated blood cultures result in unnecessary antibiotic use, increased length of stay, and additional laboratory tests, all of which increase healthcare costs. While the optimal skin antisepsis agent for reducing blood culture contamination is not known, the cost of various agents differs substantially. Objective: To determine the relative rates of blood culture contamination for 3 skin antisepsis interventions - 10% povidone iodine aqueous solution (PI), 2% iodine tincture (IT) and 2% chlorhexidine gluconate in 70% isopropyl alcohol (CHG) - when used by dedicated phlebotomy teams to obtain peripheral blood cultures in adult non-ICU medical and surgical patients.
Detailed description
A group-randomized crossover trial was conducted to test the null hypothesis of no difference in blood culture contamination rates among 3 antiseptic skin preparations. The sequence of 3 different antiseptic treatments was randomly assigned to 3 separate hospital floors, therefore in this trial cross-over occurred at the hospital floor level (not the individual patient level). Also, it is possible for subjects to have multiple blood culture sets obtained during the study. Thus, the number of blood culture sets will not equal the number of unique subjects in the study.
Interventions
DRUGIodine tincture
Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS)
DRUGChlorhexidine gluconate
2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS)
DRUGPovidone iodine
10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS)
Sponsors
Blue Cross Blue Shield of Michigan Foundation
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient on general medical, surgical, and cardiology floors * Receipt of a peripheral blood draw for blood culture collection * Blood draw performed by phlebotomy team
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Culture Contamination | 5 days | A culture set was considered contaminated if it yielded growth of typical skin contaminants including aerobic gram positive rods, Lactobacillus sp, Propionibacterium acnes, Micrococcus sp, Bacillus sp (not B. anthracis or B. cereus), coag negative Staphylococcus, Neisseria sp (not N. meningitides or N. gonorrhoeae), or gamma-hemolytic streptococci (not Enterococcus sp) from only 1 of 2 or more blood culture sets obtained from different sites. |
Participant flow
Recruitment details
Please note: it is possible for a single patient to have multiple blood culture sets obtained throughout the study. Therefore, number of blood culture sets will differ from the number of unique patients. Also, cross-over assignment occurred at the hospital floor level - not the individual subject level.
Participants by arm
| Arm | Count |
|---|---|
| Total Population | 3,879 |
| Total | 3,879 |
Baseline characteristics
| Characteristic | Total Population |
|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 17.9 |
| Sex/Gender, Customized Female | 0 participants |
| Sex/Gender, Customized Male | 0 participants |
| Sex/Gender, Customized Unknown | 3879 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 1,421 | 0 / 1,410 | 0 / 1,379 |
| serious Total, serious adverse events | 0 / 1,421 | 0 / 1,410 | 0 / 1,379 |
Outcome results
Primary
Blood Culture Contamination
A culture set was considered contaminated if it yielded growth of typical skin contaminants including aerobic gram positive rods, Lactobacillus sp, Propionibacterium acnes, Micrococcus sp, Bacillus sp (not B. anthracis or B. cereus), coag negative Staphylococcus, Neisseria sp (not N. meningitides or N. gonorrhoeae), or gamma-hemolytic streptococci (not Enterococcus sp) from only 1 of 2 or more blood culture sets obtained from different sites.
Time frame: 5 days
Population: Intention to treat analyses. Please note: it is possible for a single patient to have multiple blood culture sets obtained throughout the study. Therefore, number of blood culture sets will differ from the number of unique patients.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Chlorhexidine Gluconate (CHG_ | Blood Culture Contamination | 41 blood culture sets |
| Iodine Tincture (IT) | Blood Culture Contamination | 32 blood culture sets |
| Povidone Iodine (PI) | Blood Culture Contamination | 25 blood culture sets |