Pre-surgical Antisepsis Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate

Antisepsis Clinical Trial

— sorbectol  

Official title:

Effectiveness of Pre-surgical Hand Washing in Reducing Bacterial Load, Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454619
• Other study ID #: RICBEC
• Status: Completed
• Phase: Phase 4
• Start date: July 12, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: August 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 propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of chlorhexidine digluconate and potassium sorbate 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 addition of a solution of chlorhexidine digluconate and potassium sorbate 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: August 15, 2020
• Est. primary completion date: July 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 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:
• Hand antisepsis with Clorhexidine and solution
Hand antisepsis by scrub Surgical Hand scrubbing using chlorhexidine digluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate. 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	Centro ortopedico y quirurgico del pie	Madrid	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	Change of bacterial load measured in CFU immediately after hand scrub	Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure	Change from bacterial load at 5 minutes
Secondary	Change of bacterial loadmeaured in CFU after 3 hours of hand scrub	Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure after 3 hours	Change from bacterial load at 3 hours