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

Phase 4

Completed

• Conditions: Antisepsis
• Interventions: Drug: Hand antisepsis with Clorhexidine and solution

• Registration Number: NCT04454619
• Lead Sponsor: Centro Ortopedico y Quirurgico del Pie

Brief 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.

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 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.

Study Timeline

• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-01
• Study Start: 2020-07-12
• Primary Completion: 2020-07-18
• Status Verified: 2020-08
• Study Completion: 2020-08-15
• Last Update Submitted: 2020-08-28
• Last Update Posted: 2020-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hand antisepsis with Clorhexidina and solution	Hand antisepsis with Clorhexidine and solution	chlorhexidine gluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate.
Hand antisepsis with propanolol-1 60%	Hand antisepsis with Clorhexidine and solution	Effectiveness of pre-surgical hand washing in reducing bacterial load using propanolol-1 60% as control

Primary Outcome Measures

Name	Time	Method
Change of bacterial load measured in CFU immediately after hand scrub	Change from bacterial load at 5 minutes	Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure

Secondary Outcome Measures

Name	Time	Method
Change of bacterial loadmeaured in CFU after 3 hours of hand scrub	Change from bacterial load at 3 hours	Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure after 3 hours

Trial Locations

Locations (1)

Centro ortopedico y quirurgico del pie; 🇪🇸 Madrid, Madrid., Spain