Trial Outcomes & Findings for The Antiseptic Outcome of Traditional Hand Scrubbing Versus Hand Rubbing in Surgical Room (NCT NCT02294604)

NCT ID: NCT02294604

Last Updated: 2017-03-13

Results Overview

The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 236 participants
• Primary outcome timeframe: 2 days after sampling
• Results posted on: 2017-03-13

Participant Flow

Participant milestones

Measure	Group R Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers ethyl alcochol, chlorhexidine and moisturizers	Group I Traditional scrub formation with 10 % povidone-iodine povidone-iodine	Group C Traditional scrub formation with 4% chlorhexidine chlorhexidine
Overall Study STARTED	80	80	80
Overall Study COMPLETED	79	77	80
Overall Study NOT COMPLETED	1	3	0

Reasons for withdrawal

Measure	Group R Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers ethyl alcochol, chlorhexidine and moisturizers	Group I Traditional scrub formation with 10 % povidone-iodine povidone-iodine	Group C Traditional scrub formation with 4% chlorhexidine chlorhexidine
Overall Study Did not provide samples for culture	0	1	0
Overall Study Culture contamination	1	2	0

Baseline Characteristics

The Antiseptic Outcome of Traditional Hand Scrubbing Versus Hand Rubbing in Surgical Room

Baseline characteristics by cohort

Measure	Group R n=80 Participants Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers ethyl alcochol, chlorhexidine and moisturizers	Group I n=80 Participants Traditional scrub formation with 10 % povidone-iodine povidone-iodine	Group C n=80 Participants Traditional scrub formation with 4% chlorhexidine chlorhexidine	Total n=240 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants	80 Participants n=7 Participants	80 Participants n=5 Participants	240 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex/Gender, Customized Unknown	80 participants n=5 Participants	80 participants n=7 Participants	80 participants n=5 Participants	240 participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	80 Participants n=5 Participants	80 Participants n=7 Participants	80 Participants n=5 Participants	240 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Taiwan	80 participants n=5 Participants	80 participants n=7 Participants	80 participants n=5 Participants	240 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 days after sampling

The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates

Outcome measures

Measure	Group R n=79 Participants Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers ethyl alcochol, chlorhexidine and moisturizers	Group I n=77 Participants Traditional scrub formation with 10 % povidone-iodine povidone-iodine	Group C n=80 Participants Traditional scrub formation with 4% chlorhexidine chlorhexidine
Microorganisms on Hands Before Scrubbing	28.99 colony forming unit Standard Error 3.98	38.64 colony forming unit Standard Error 4.36	22.91 colony forming unit Standard Error 3.63

SECONDARY outcome

Timeframe: 2 days after sampling

The secondary outcomes is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates

Outcome measures

Measure	Group R n=79 Participants Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers ethyl alcochol, chlorhexidine and moisturizers	Group I n=77 Participants Traditional scrub formation with 10 % povidone-iodine povidone-iodine	Group C n=80 Participants Traditional scrub formation with 4% chlorhexidine chlorhexidine
Microorganisms on Hands After Scrubbing	1.38 colony forming unit Standard Error 0.74	4.29 colony forming unit Standard Error 1.25	0.48 colony forming unit Standard Error 0.22

SECONDARY outcome

Timeframe: 2 days after sampling

The secondary outcomes is the colonies grown on bacterial culture plate

Outcome measures

Measure	Group R n=79 Participants Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers ethyl alcochol, chlorhexidine and moisturizers	Group I n=77 Participants Traditional scrub formation with 10 % povidone-iodine povidone-iodine	Group C n=80 Participants Traditional scrub formation with 4% chlorhexidine chlorhexidine
Microorganisms on Hands After Surgery	4.7 colony forming unit Standard Error 1.8	3.9 colony forming unit Standard Error 1.6	4.1 colony forming unit Standard Error 1.9

SECONDARY outcome

Timeframe: Immediately

The secondary outcome is the duration of hand washing

Outcome measures

Measure	Group R n=79 Participants Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers ethyl alcochol, chlorhexidine and moisturizers	Group I n=77 Participants Traditional scrub formation with 10 % povidone-iodine povidone-iodine	Group C n=80 Participants Traditional scrub formation with 4% chlorhexidine chlorhexidine
Duration of Hand Washing	3.2 Minute Standard Error 0.2	3.64 Minute Standard Error 0.2	4.8 Minute Standard Error 0.8

Adverse Events

Group R

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group I

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group C

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

Dr. Ka-Wai Tam

Shuang Ho Hospital, Taipei Medical University

Phone: 886-2-22490088

Email: kelvintam@h.tmu.edu.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place