Hand Disinfection
Conditions
Brief summary
Hand hygiene is the cornerstone of aseptic techniques to reduce surgical site infection. The traditional surgical antisepsis involves scrubbing the skin with povidone-iodine or chlorhexidine gluconate. Recently, a waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers was developed to provide a comparable antiseptic effect. The investigators perform a randomized controlled trial to compare the antiseptic effectiveness of the waterless hand rubbing, the classic surgical handwashing with povidone-iodine and chlorhexidine solutions.
Detailed description
This single centre, randomized trial recruited surgical team members in Taipei Medical University-Shuang Ho Hospital at November 2014. 255 episodes of hand washing are enrolled. The participants are assigned equally to use either a waterless hand rub (Group R), or traditional scrub formation with 10 % povidone-iodine (Group I) and 4% chlorhexidine (Group C). Hand washing time, microorganisms on hands before and after scrubbing is recorded. The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates after hand washing. The secondary outcomes is hand microbial flora after surgery and duration of hand washing.
Interventions
DEVICEethyl alcochol, chlorhexidine and moisturizers
DEVICEchlorhexidine
DEVICEpovidone-iodine
Sponsors
Taipei Medical University Shuang Ho Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Surgical staff members, both surgeons and scrub nurses
Exclusion criteria
* Participants were excluded if they were medical or nursing students * Allergy to the experimental materials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microorganisms on Hands Before Scrubbing | 2 days after sampling | The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Hand Washing | Immediately | The secondary outcome is the duration of hand washing |
| Microorganisms on Hands After Scrubbing | 2 days after sampling | The secondary outcomes is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates |
| Microorganisms on Hands After Surgery | 2 days after sampling | The secondary outcomes is the colonies grown on bacterial culture plate |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group R Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers
ethyl alcochol, chlorhexidine and moisturizers | 80 |
| Group I Traditional scrub formation with 10 % povidone-iodine
povidone-iodine | 80 |
| Group C Traditional scrub formation with 4% chlorhexidine
chlorhexidine | 80 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Culture contamination | 1 | 2 | 0 |
| Overall Study | Did not provide samples for culture | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Group R | Group I | Group C | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants | 80 Participants | 80 Participants | 240 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 80 Participants | 80 Participants | 80 Participants | 240 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 80 participants | 80 participants | 80 participants | 240 participants |
| Sex/Gender, Customized Unknown | 80 participants | 80 participants | 80 participants | 240 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 77 | 0 / 80 |
| other Total, other adverse events | 0 / 79 | 0 / 77 | 0 / 80 |
| serious Total, serious adverse events | 0 / 79 | 0 / 77 | 0 / 80 |
Outcome results
Primary
Microorganisms on Hands Before Scrubbing
The primary outcome is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates
Time frame: 2 days after sampling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group R | Microorganisms on Hands Before Scrubbing | 28.99 colony forming unit | Standard Error 3.98 |
| Group I | Microorganisms on Hands Before Scrubbing | 38.64 colony forming unit | Standard Error 4.36 |
| Group C | Microorganisms on Hands Before Scrubbing | 22.91 colony forming unit | Standard Error 3.63 |
Secondary
Duration of Hand Washing
The secondary outcome is the duration of hand washing
Time frame: Immediately
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group R | Duration of Hand Washing | 3.2 Minute | Standard Error 0.2 |
| Group I | Duration of Hand Washing | 3.64 Minute | Standard Error 0.2 |
| Group C | Duration of Hand Washing | 4.8 Minute | Standard Error 0.8 |
Secondary
Microorganisms on Hands After Scrubbing
The secondary outcomes is the colonies grown on bacterial culture plates and expressed as colony-forming units (CFU) on plates
Time frame: 2 days after sampling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group R | Microorganisms on Hands After Scrubbing | 1.38 colony forming unit | Standard Error 0.74 |
| Group I | Microorganisms on Hands After Scrubbing | 4.29 colony forming unit | Standard Error 1.25 |
| Group C | Microorganisms on Hands After Scrubbing | 0.48 colony forming unit | Standard Error 0.22 |
Secondary
Microorganisms on Hands After Surgery
The secondary outcomes is the colonies grown on bacterial culture plate
Time frame: 2 days after sampling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group R | Microorganisms on Hands After Surgery | 4.7 colony forming unit | Standard Error 1.8 |
| Group I | Microorganisms on Hands After Surgery | 3.9 colony forming unit | Standard Error 1.6 |
| Group C | Microorganisms on Hands After Surgery | 4.1 colony forming unit | Standard Error 1.9 |