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

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 scrub antisepsis using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of 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 preoperative surgical scrubbing using propan-ol-1 60% by scrub using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of 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 Clorhexidine and solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants without systemic pathologies, with healthy skin of the hands and short fingernails. They do not use substances with antibacterial action. Exclusion Criteria: Taken antibiotics before 10 days of the intervention. Wear any jewellery on the hands

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 propanolol-1 60% as control | Drug: Hand antisepsis with Clorhexidine and solution<br>* Hand antisepsis by scrub Surgical Hand scrubbing using chlorhexidine digluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate. both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side<br>* Other names: Clorhexidine and alholic solution dicluconate cloehexidine and potassium sorbate;|
| Experimental: Hand antisepsis with Clorhexidina and solution<br>chlorhexidine gluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate. | Drug: Hand antisepsis with Clorhexidine and solution<br>* Hand antisepsis by scrub Surgical Hand scrubbing using chlorhexidine digluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate. both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side<br>* Other names: Clorhexidine and alholic solution dicluconate cloehexidine and potassium sorbate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of bacterial load measured in CFU 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 |
| --- | --- | --- |
| Change of bacterial loadmeaured in CFU 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 |