NCT04683146

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Centro Ortopedico y Quirurgico del Pie · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The present study evaluates the effects of bactericidal load reduction after surgical hand antisepsis using the reference antiseptic product propanol- 1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, 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 surgical hand antisepsis using propan-ol-1 60% by using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand antisepsis with addition of a solution of alcohol, 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.

Conditions

• Antisepsis

Interventions

Type	Name	Description
DRUG	Hand antisepsis with Propanolol- 1 60%.	* Pre-washing for one minute with neutral soap to remove the transient flora. * Hand antisepsis using Propanolol-1 60% in both hands. * Bacterial sample collection from right hand. * Sterile surgical glove in both hands. * Bacterial sample collection from left hand three hours later
DRUG	Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.	* Pre-washing for one minute with neutral soap to remove the transient flora. * Hand antisepsis using a solution of alcohol, chlorhexidine digluconate and potassium sorbate. * Bacterial sample collection from right hand. * Sterile surgical glove in both hands. * Bacterial sample collection from left hand three hours later.

Timeline

• Start date: 2021-03-10
• Primary completion: 2021-03-24
• Completion: 2021-06-05
• First posted: 2020-12-24
• Last updated: 2020-12-24