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NCT Number: NCT01216761

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

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.

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Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iodine tincture

Drug

Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS)

Chlorhexidine gluconate

Drug

2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS)

Povidone iodine

Drug

10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS)

Primary outcomes

  1. Blood Culture Contamination

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Blue Cross Blue Shield of Michigan Foundation

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 7, 2010
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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