Pre-surgical Antisepsis Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate ( Sorbectol )

Study Overview
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Brief Summary
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The present study evaluates the effects of bactericidal load reduction after surgical hand antisepsis using the reference antiseptic product propanol- 1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, chlorhexidine digluconate and potassium sorbate in order to test if pass the standard european norm 12791.

Detailed Description
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The investigators conducted a crossover clinical trial to evaluate the antiseptic effectiveness of surgical hand antisepsis using propan-ol-1 60% by using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, chlorhexidine digluconate and potassium sorbate in order to test if pass the standard european norm 12791. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.

Official Title
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Effectiveness of Pre-surgical Hand Washing in Reducing Bacterial Load, Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate

Conditions
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Antisepsis

Intervention / Treatment
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* Drug: Hand antisepsis with Propanolol- 1 60%.
* Drug: Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with healthy skin in both hands and short fingernails. No use of antibacterial agents for at least three days before the intervention. Not received antibiotic treatment for at least ten days before the intervention. Exclusion Criteria: Known systemic pathologies Wearing hand jewelry on the hands Allergy to any ingredient of which the solutions used in the clinical trial are composed Cognitive and / or motor limitation that makes it impossible to carry out instructions for hand washing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover Assignment Crossover design is used
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hand antisepsis with propanolol-1 60%<br>Effectiveness of pre-surgical hand washing in reducing bacterial load using propranolol- 1 60% as control. | Drug: Hand antisepsis with Propanolol- 1 60%.<br>* Pre-washing for one minute with neutral soap to remove the transient flora. Hand antisepsis using Propanolol-1 60% in both hands. Bacterial sample collection from right hand. Sterile surgical glove in both hands. Bacterial sample collection from left hand three hours later<br>Drug: Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.<br>* Pre-washing for one minute with neutral soap to remove the transient flora. Hand antisepsis using a solution of alcohol, chlorhexidine digluconate and potassium sorbate. Bacterial sample collection from right hand. Sterile surgical glove in both hands. Bacterial sample collection from left hand three hours later.<br>|
| Active Comparator: Hand antisepsis with solution of alcohol, chlorhexidine digluconate and potassium sorbate<br>Effectiveness of pre-surgical hand washing in reducing bacterial load using a solution of alcohol, chlorhexidine digluconate and potassium sorbate | Drug: Hand antisepsis with Propanolol- 1 60%.<br>* Pre-washing for one minute with neutral soap to remove the transient flora. Hand antisepsis using Propanolol-1 60% in both hands. Bacterial sample collection from right hand. Sterile surgical glove in both hands. Bacterial sample collection from left hand three hours later<br>Drug: Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.<br>* Pre-washing for one minute with neutral soap to remove the transient flora. Hand antisepsis using a solution of alcohol, chlorhexidine digluconate and potassium sorbate. Bacterial sample collection from right hand. Sterile surgical glove in both hands. Bacterial sample collection from left hand three hours later.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of bacterial load immediately after hand scrub | Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure | Change from bacterial load at 5 minutes] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of bacterial load after 3 hours of hand scrub | Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure after 3 hours | Change from bacterial load at 3 hours |