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

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.

Study Overview

• Status: Completed
• Conditions: Antisepsis
• Intervention / Treatment: Drug: Hand antisepsis with Clorhexidine and 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 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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Madrid.
    • Madrid, Madrid., Spain, 28040
      • Centro Ortopedico y Quirurgico del Pie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older 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: 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; Other Names: Clorhexidine and alholic solution dicluconate cloehexidine and potassium sorbate
Experimental: Hand antisepsis with Clorhexidina and solution; chlorhexidine gluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate.	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; Other Names: Clorhexidine and alholic solution dicluconate cloehexidine and potassium sorbate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2020
• Primary Completion (Actual): July 18, 2020
• Study Completion (Actual): August 15, 2020

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 28, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: RICBEC

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