Clinical trial NCT01216761
Conditions: Bacteremia
Keywords: Bacteremia Blood culture Contamination Antiseptic agents
Sponsor: University of Michigan
Start date: 2008-05-01; Completion date: 2009-11-01
Enrollment: 3879 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

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.

Arms: arm 1: 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 arm 2: 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 arm 3: 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
Interventions: intervention 1: Iodine tincture intervention 2: Chlorhexidine gluconate intervention 3: Povidone iodine
Intervention descriptions: intervention 1: Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) intervention 2: 2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) intervention 3: 10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS)

Protocol documents: