A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Bacteremia |
Drug: Iodine tincture Drug: Chlorhexidine gluconate Drug: Povidone iodine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Blood Culture Contamination: A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions |
- Blood Culture Contamination [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 3879 |
| Study Start Date: | May 2008 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: CHG then PI then IT
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
Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS)
Drug: Chlorhexidine gluconate
2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS)
Drug: Povidone iodine
10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS)
|
|
Active Comparator: IT then CHG then PI
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
Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS)
Drug: Chlorhexidine gluconate
2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS)
Drug: Povidone iodine
10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS)
|
|
Active Comparator: PI then IT then CHG
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
Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS)
Drug: Chlorhexidine gluconate
2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS)
Drug: Povidone iodine
10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations More Information
No publications provided by University of Michigan Health System
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Laraine Washer, Assistant Professor of Internal Medicine, University of Michigan Health System |
| ClinicalTrials.gov Identifier: | NCT01216761 History of Changes |
| Other Study ID Numbers: | N010316 - 1932.II |
| Study First Received: | October 6, 2010 |
| Results First Received: | October 7, 2011 |
| Last Updated: | October 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan Health System:
|
Bacteremia Blood culture Contamination Antiseptic agents |
Additional relevant MeSH terms:
|
Bacteremia Bacterial Infections Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Anti-Infective Agents, Local Chlorhexidine Chlorhexidine gluconate Iodine Cadexomer iodine Povidone-Iodine |
Povidone Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Plasma Substitutes Blood Substitutes Hematologic Agents Disinfectants Dermatologic Agents Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013