Pre-surgical Antisepsis of Hands After Washing With Triclosan 0.5% Compared to Propan-1-ol 60%

Sponsor

Centro Ortopedico y Quirurgico del Pie (Other)

Overall Status

Completed

CT.gov ID

NCT04538365

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

25.2

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 propanol-

1 60% as control versus a surgical hand scrub antisepsis with triclosan 0.5% in order to test if pass the standard european norm 12791.

Condition or Disease	Intervention/Treatment	Phase
Antisepsis	Drug: Triclosan 0.5 % Topical Solution Drug: propanolol	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 trocilosan 0.5% 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 design is usedCrossover design is used

Masking:

Single (Outcomes Assessor)

Masking Description:

The samples will be sent to the laboratory with numbers

Primary Purpose:

Treatment

Official Title:

Effect on the Reduction of Bacterial Load in Surgical Antisepsis of Hands After Washing With Triclosan 0.5% Compared to Propan-1-ol 60% Used as Reference Disinfectant

Actual Study Start Date :

Oct 1, 2020

Actual Primary Completion Date :

Oct 20, 2020

Actual Study Completion Date :

Oct 30, 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: propanolol Hand antisepsis by scrub Surgical Hand scrubbing using Propanolol 60% solution 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: Hand antisepsis with Propanolol 60% solution
Experimental: Hand antisepsis with triclosan solution Effectiveness of pre-surgical hand washing in reducing bacterial load using triclosan 0.5% solution	Drug: Triclosan 0.5 % Topical Solution Hand antisepsis by scrub Surgical Hand scrubbing using triclosan 0.5% solution 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: Hand antisepsis with Triclosan 0.5% solution.

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: propanolol

Hand antisepsis by scrub Surgical Hand scrubbing using Propanolol 60% solution 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:

Hand antisepsis with Propanolol 60% solution

Experimental: Hand antisepsis with triclosan solution

Effectiveness of pre-surgical hand washing in reducing bacterial load using triclosan 0.5% solution

Drug: Triclosan 0.5 % Topical Solution

Hand antisepsis by scrub Surgical Hand scrubbing using triclosan 0.5% solution 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:

Hand antisepsis with Triclosan 0.5% solution.

Outcome Measures

Primary Outcome Measures

Reduction of bacterial load immediately after hand scrub [Change from bacterial load at 5 minutes]
Participants will scrub with the antiseptic solution vigorously from hand to the wrists according with the standard handscrub procedure

Secondary Outcome Measures

Reduction of bacterial load after 3 hours of hand scrub [Change from bacterial load after 3 hours]
Participants will scrub with the antiseptic solution vigorously from hand to the wrists according with the standard handscrub after 3 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 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	Facultad de Enfermeria, Fisioterapia y Podologia	Madrid		Spain	28040

Sponsors and Collaborators

Centro Ortopedico y Quirurgico del Pie

Investigators

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

NCT04538365

Other Study ID Numbers:

RICBEC1

First Posted:

Sep 4, 2020

Last Update Posted:

Nov 2, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ricardo Becerro de Bengoa Vallejo, Principal Investigator, Centro Ortopedico y Quirurgico del Pie

hand washing

presurgical antisepsis

Additional relevant MeSH terms:

Triclosan

Propranolol

Pharmaceutical Solutions

Study Results

No Results Posted as of Nov 2, 2020