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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hand Disinfection

Intervention / Treatment
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* Device: ethyl alcochol, chlorhexidine and moisturizers
* Device: chlorhexidine
* Device: povidone-iodine


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group R<br>Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers | Device: ethyl alcochol, chlorhexidine and moisturizers<br> <br> * Other names: Avagard;|
| Active Comparator: Group I<br>Traditional scrub formation with 10 % povidone-iodine | Device: povidone-iodine<br> <br> |
| Active Comparator: Group C<br>Traditional scrub formation with 4% chlorhexidine | Device: chlorhexidine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |