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

Antisepsis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538365
• Other study ID #: RICBEC1
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: October 2020
• Source: Centro Ortopedico y Quirurgico del Pie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 30, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Antisepsis

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Facultad de Enfermeria, Fisioterapia y Podologia	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Centro Ortopedico y Quirurgico del Pie

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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