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

NCT04538365 | Completed Phase 4

• 1 other identifier: RICBEC1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Antisepsis

Keywords

hand washing; presurgical antisepsis

Outcome Measures

Primary Outcomes (1)

• Reduction of bacterial load immediately after hand scrub

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

  Change from bacterial load at 5 minutes

Secondary Outcomes (1)

• Reduction of bacterial load after 3 hours of hand scrub

  Change from bacterial load after 3 hours

Study Arms (2)

Hand antisepsis with propanolol-1 60%

ACTIVE COMPARATOR

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

Drug: propanolol

Hand antisepsis with triclosan solution

EXPERIMENTAL

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

Drug: Triclosan 0.5 % Topical Solution

Interventions

Triclosan 0.5 % Topical Solution DRUG

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

Also known as: Hand antisepsis with Triclosan 0.5% solution.

Hand antisepsis with triclosan solution

propanolol DRUG

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

Also known as: Hand antisepsis with Propanolol 60% solution

Hand antisepsis with propanolol-1 60%

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants without systemic pathologies, with healthy skin of the hands and short fingernails.
• They do not use substances with antibacterial action.

You may not qualify if:

• Taken antibiotics before 10 days of the intervention.
• Wear any jewellery on the hands

Sponsors & Collaborators

• Centro Ortopedico y Quirurgico del Pie: lead

Study Sites (1)

Facultad de Enfermeria, Fisioterapia y Podologia

Madrid, 28040, Spain

Location

Related Publications (1)

• Sante L, Gomez-Lus ML, Martin-Villa C, Becerro-de-Bengoa-Vallejo R, Alou L, Sevillano D. Effect on the reduction of bacterial load after surgical hand antisepsis with triclosan 0.5% compared to triclosan 0.5% followed by 70% alcoholic solution. Infect Control Hosp Epidemiol. 2023 Mar;44(3):517-519. doi: 10.1017/ice.2021.506. Epub 2021 Dec 22.

  PMID: 34933701 DERIVED

MeSH Terms

Interventions

Triclosan; Solutions; Propranolol

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pharmaceutical Preparations; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ricardo B Becerro de Bengoa Vallejo, PhD

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The samples will be sent to the laboratory with numbers
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Crossover design is used

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 4, 2020
• Study Start: October 1, 2020
• Primary Completion: October 20, 2020
• Study Completion: October 30, 2020
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)