An interventional study of Iodine tincture and Chlorhexidine gluconate in Bacteremia, sponsored by University of Michigan. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-11.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
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.
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.
322 studies on the registry are indexed under Bacteremia; 49 are open to participants now.
This study's enrollment of 3,879 is above the median of 149 across 171 interventional studies indexed under Bacteremia.
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Exclusion Criteria:
Skin antisepsis prior to any peripheral blood culture collection on Floor A was performed with CHG for 3 months, followed by PI for 3 months, followed by IT for 3 months. Each 3 month intervention period was separated by a one month wash out period where data regarding blood culture contamination was not collected. 2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG 10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT
Drug: Iodine tincture · Drug: Chlorhexidine gluconate · Drug: Povidone iodine
Skin antisepsis prior to any peripheral blood culture collection on Floor B was performed with iodine tincture for 3 months, followed by Chlorhexidine gluconate for 3 months, followed by povidone iodine for 3 months. Each 3 month intervention period was separated by a one month wash out period where data regarding blood culture contamination was not collected. Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT 2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG 10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI
Drug: Iodine tincture · Drug: Chlorhexidine gluconate · Drug: Povidone iodine
Skin antisepsis prior to any peripheral blood culture collection on Floor C was performed with povidone iodine for 3 months, followed by iodine tincture for 3 months, followed by chlorhexidine gluconate for 3 months. Each 3 3 month intervention period was separated by a one month wash out period where data regarding blood culture contamination was not collected. 10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT 2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG
Drug: Iodine tincture · Drug: Chlorhexidine gluconate · Drug: Povidone iodine
Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS)
2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS)
10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS)
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
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.
| Milestone | CHG Then PI Then IT | IT Then CHG Then PI | PI Then IT Then CHG |
|---|---|---|---|
| Started | 1421 | 1410 | 1379 |
| Completed | 1421 | 1410 | 1379 |
| Not completed | 0 | 0 | 0 |
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.
| blood culture sets | Chlorhexidine Gluconate (CHG_ | Iodine Tincture (IT) | Povidone Iodine (PI) |
|---|---|---|---|
| Blood Culture Contamination | 41 | 32 | 25 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CHG Then PI Then IT | — | 0/1,421 (0%) | 0/1,421 (0%) |
| IT Then CHG Then PI | — | 0/1,410 (0%) | 0/1,410 (0%) |
| PI Then IT Then CHG | — | 0/1,379 (0%) | 0/1,379 (0%) |
| Age, Continuous(years) | Total Population |
|---|---|
| Mean | 56.8 ± 17.9 |
| Sex/Gender, Customized(participants) | Total Population |
|---|---|
| Male | 0 |
| Female | 0 |
| Unknown | 3879 |
No study locations are listed for this record.
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