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Clinical Trials/NCT04446923
NCT04446923CompletedPhase 4

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

Universidad Complutense de Madrid1 site in 1 country24 target enrollmentStarted: June 28, 2020Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
Reduction of bacterial load immediately after hand scrub
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

The samples will be sent to the laboratory with numbers.

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
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.

Arms & Interventions

Hand antisepsis by scrub

Experimental

Hand antisepsis by scrub using propan-ol-1 60%

Intervention: Hand antisepsis by scrub (Drug)

Hand antisepsis by rub

Active Comparator

Hand antisepsis by rub using propan-ol-1 60%

Intervention: Hand antisepsis by scrub (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • Reduction of bacterial load after 3 hours of hand scrub(Change from bacterial load at 3 hours.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

César Calvo Lobo

Principal Investigator

Universidad Complutense de Madrid

Study Sites (1)

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Surgical Hand Antisepsis With Propan-ol-1... | Clinical Trial