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

Sponsor
Centro Ortopedico y Quirurgico del Pie (Other)
Overall Status
Completed
CT.gov ID
NCT04454619
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
1.1
Actual Duration (Months)
21.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hand antisepsis with Clorhexidine and solution
 Phase 4

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Crossover Assignment Crossover design is usedCrossover Assignment Crossover design is used
Masking:
Single (Outcomes Assessor)
Masking Description:
The samples will be sent to the laboratory with numbers
Primary Purpose:
Treatment
Official Title:
Effectiveness of Pre-surgical Hand Washing in Reducing Bacterial Load, Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate
Actual Study Start Date :
Jul 12, 2020
Actual Primary Completion Date :
Jul 18, 2020
Actual Study Completion Date :
Aug 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Hand antisepsis with propanolol-1 60%

Effectiveness of pre-surgical hand washing in reducing bacterial load using propanolol-1 60% as control

Drug: Hand antisepsis with Clorhexidine and solution
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
Other Names:
  • Clorhexidine and alholic solution dicluconate cloehexidine and potassium sorbate

    		•
    Experimental: Hand antisepsis with Clorhexidina and solution

    chlorhexidine gluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate.

    Drug: Hand antisepsis with Clorhexidine and solution
    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
    Other Names:
  • Clorhexidine and alholic solution dicluconate cloehexidine and potassium sorbate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of bacterial load measured in CFU immediately after hand scrub [Change from bacterial load at 5 minutes]

      Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure

    Secondary Outcome Measures

    1. Change of bacterial loadmeaured in CFU after 3 hours of hand scrub [Change from bacterial load at 3 hours]

      Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure after 3 hours

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centro ortopedico y quirurgico del pie Madrid Madrid. Spain 28040

    Sponsors and Collaborators

    • Centro Ortopedico y Quirurgico del Pie

    Investigators

    • Principal Investigator: Ricardo Becerro de Bengoa Vallejo, Universidad Complutense de Madrid

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ricardo Becerro de Bengoa Vallejo, Principal Investigator, Centro Ortopedico y Quirurgico del Pie
    ClinicalTrials.gov Identifier:
    NCT04454619
    Other Study ID Numbers:
    • RICBEC
    First Posted:
    Jul 1, 2020
    Last Update Posted:
    Aug 31, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Aug 31, 2020