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

July 20, 2020 updated by: César Calvo Lobo, Universidad Complutense de Madrid

Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing in Accordance With European Norm Regulation 12791

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Ricardo Becerro de Bengoa Vallejo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hand antisepsis by scrub
Hand antisepsis by scrub using propan-ol-1 60%
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.
Other Names:
  • Propanolol
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.
Other Names:
  • Propanolol
Active Comparator: Hand antisepsis by rub
Hand antisepsis by rub using propan-ol-1 60%
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.
Other Names:
  • Propanolol
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.
Other Names:
  • Propanolol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
Change from bacterial load at 3 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Investigators

  • Principal Investigator: Ricardo Becerro de Bengoa Vallejo, PhD, Ricardo Becerro de Bengoa Vallejo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2020

Primary Completion (Actual)

July 18, 2020

Study Completion (Actual)

July 20, 2020

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RICBEC1-UCM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A number will be assigned to each participant

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe