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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group R | Experimental | Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers |
|
| Group I | Active Comparator | Traditional scrub formation with 10 % povidone-iodine |
|
| Group C | Active Comparator | Traditional scrub formation with 4% chlorhexidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ethyl alcochol, chlorhexidine and moisturizers | Device |
|
| |
| chlorhexidine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 days after sampling |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 days after sampling |
| Microorganisms on Hands After Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ka-Wai Tam, MD, MS | Taipei Medical University Shuang Ho Hospital | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group R | Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers ethyl alcochol, chlorhexidine and moisturizers |
| FG001 | Group I | Traditional scrub formation with 10 % povidone-iodine povidone-iodine |
| FG002 | Group C | Traditional scrub formation with 4% chlorhexidine chlorhexidine |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group R | Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers ethyl alcochol, chlorhexidine and moisturizers |
| BG001 | Group I |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Error | colony forming unit | 2 days after sampling |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group R | Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers ethyl alcochol, chlorhexidine and moisturizers |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ka-Wai Tam | Shuang Ho Hospital, Taipei Medical University | 886-2-22490088 | 8860 | kelvintam@h.tmu.edu.tw |
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| Device |
|
| povidone-iodine | Device |
|
The secondary outcomes is the colonies grown on bacterial culture plate
| 2 days after sampling |
| Duration of Hand Washing | The secondary outcome is the duration of hand washing | Immediately |
Traditional scrub formation with 10 % povidone-iodine
povidone-iodine
| BG002 | Group C | Traditional scrub formation with 4% chlorhexidine chlorhexidine |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Gender was not assessed | Number | participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Traditional scrub formation with 4% chlorhexidine chlorhexidine |
|
|
| 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 | Posted | Mean | Standard Error | colony forming unit | 2 days after sampling |
|
|
|
| Secondary | Microorganisms on Hands After Surgery | The secondary outcomes is the colonies grown on bacterial culture plate | Posted | Mean | Standard Error | colony forming unit | 2 days after sampling |
|
|
|
| Secondary | Duration of Hand Washing | The secondary outcome is the duration of hand washing | Posted | Mean | Standard Error | Minute | Immediately |
|
|
|
| 0 |
| 79 |
| 0 |
| 79 |
| 0 |
| 79 |
| EG001 | Group I | Traditional scrub formation with 10 % povidone-iodine povidone-iodine | 0 | 77 | 0 | 77 | 0 | 77 |
| EG002 | Group C | Traditional scrub formation with 4% chlorhexidine chlorhexidine | 0 | 80 | 0 | 80 | 0 | 80 |
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