Trial Outcomes & Findings for A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions (NCT NCT01216761)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3879 participants

Primary outcome timeframe

5 days

Results posted on

2017-01-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure	CHG Then PI Then 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 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	IT Then CHG Then 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 10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI	PI Then IT Then 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 2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG
Overall Study STARTED	1421	1410	1379
Overall Study COMPLETED	1421	1410	1379
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Population n=3879 Participants
Age, Continuous	56.8 years STANDARD_DEVIATION 17.9 • n=5 Participants
Sex/Gender, Customized Male	0 participants n=5 Participants
Sex/Gender, Customized Female	0 participants n=5 Participants
Sex/Gender, Customized Unknown	3879 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Population: Intention to treat analyses. 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.

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.

Outcome measures

Outcome measures
Measure	Chlorhexidine Gluconate (CHG_ n=4388 Blood culture sets 2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG	Iodine Tincture (IT) n=4230 Blood culture sets 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	Povidone Iodine (PI) n=4286 Blood culture sets 10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI
Blood Culture Contamination	41 blood culture sets	32 blood culture sets	25 blood culture sets

Adverse Events

CHG Then PI Then IT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

IT Then CHG Then PI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PI Then IT Then CHG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Laraine Washer, MD

University of Michigan Health System

Phone: 734-936-5205

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place