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

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

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.

Study Overview

• Status: Completed
• Conditions: Antisepsis
• Intervention / Treatment: Drug: propanolol; Drug: Triclosan 0.5 % Topical Solution

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Facultad de Enfermería, Fisioterapia y Podología

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of bacterial load after 3 hours of hand scrub	Participants will scrub with the antiseptic solution vigorously from hand to the wrists according with the standard handscrub after 3 hours	Change from bacterial load after 3 hours

Collaborators and Investigators

• Sponsor: Centro Ortopedico y Quirurgico del Pie
• Investigators: Principal Investigator: Ricardo B Becerro de Bengoa Vallejo, PhD, Universidad Complutense de Madrid

Publications and helpful links

General Publications

• 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. 2021 Dec 22:1-3. doi: 10.1017/ice.2021.506. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): October 20, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: August 29, 2020
• First Submitted That Met QC Criteria: August 29, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: hand washing; presurgical antisepsis
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Anti-Infective Agents, Local; Anti-Infective Agents; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fatty Acid Synthesis Inhibitors; Propranolol; Pharmaceutical Solutions; Triclosan
• Other Study ID Numbers: RICBEC1

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