Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing

Overview

The present study evaluates the effects of to compare bactericidal efficacy using the reference antiseptic product propan-ol-1 60% using the hand rub method versus hand scrub method in order to test if pass the standard european norm 12791.

Full Title of Study: “Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing in Accordance With European Norm Regulation 12791”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: July 18, 2020

Detailed Description

The investigators conducted a crossover clinical trial to evaluate the antiseptic effectiveness of preoperative surgical scrubbing using propan-ol-1 60% by rub and scrub. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.

Interventions

  • Drug: Hand antisepsis by scrub
    • Surgical Hand scrubbing using P-1 of both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side.
  • Drug: Hand antisepsis by scrub
    • Surgical Hand rubbing using P-1 of both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side.

Arms, Groups and Cohorts

  • Experimental: Hand antisepsis by scrub
    • Hand antisepsis by scrub using propan-ol-1 60%
  • Active Comparator: Hand antisepsis by rub
    • Hand antisepsis by rub using propan-ol-1 60%

Clinical Trial Outcome Measures

Primary Measures

  • Reduction of bacterial load immediately after hand scrub
    • Time Frame: Change from bacterial load at 5 minutes.
    • Participants will scrub the liquid vigorously from hand to the wrists according with the standard handrub procedure.

Secondary Measures

  • Reduction of bacterial load after 3 hours of hand scrub
    • Time Frame: Change from bacterial load at 3 hours.
    • Participants will scrub the liquid vigorously from hand to the wrists according with the standard handrub procedure after 3 hours

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universidad Complutense de Madrid
  • Provider of Information About this Clinical Study
    • Principal Investigator: César Calvo Lobo, Principal Investigator – Universidad Complutense de Madrid
  • Overall Official(s)
    • Ricardo Becerro de Bengoa Vallejo, PhD, Principal Investigator, Ricardo becerro de Bengoa Vallejo

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