A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Blood Culture Contamination: A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions

Conditions
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Bacteremia

Intervention / Treatment
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* Drug: Iodine tincture
* Drug: Chlorhexidine gluconate
* Drug: Povidone iodine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CHG then PI then IT<br>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<br>* Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS)<br>Drug: Chlorhexidine gluconate<br>* 2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS)<br>Drug: Povidone iodine<br>* 10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS)<br>|
| Active Comparator: IT then CHG then PI<br>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<br>* Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS)<br>Drug: Chlorhexidine gluconate<br>* 2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS)<br>Drug: Povidone iodine<br>* 10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS)<br>|
| Active Comparator: PI then IT then CHG<br>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<br>* Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS)<br>Drug: Chlorhexidine gluconate<br>* 2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS)<br>Drug: Povidone iodine<br>* 10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacteremia, Blood culture, Contamination, Antiseptic agents