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

NCT04454619 | Completed Phase 4

• 1 other identifier: RICBEC
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Antisepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change of bacterial loadmeaured in CFU after 3 hours of hand scrub

  Change from bacterial load at 3 hours

Study Arms (2)

Hand antisepsis with propanolol-1 60%

ACTIVE COMPARATOR

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 with Clorhexidina and solution

EXPERIMENTAL

chlorhexidine gluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate.

Drug: Hand antisepsis with Clorhexidine and solution

Interventions

Hand antisepsis with Clorhexidine and solution DRUG

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

Also known as: Clorhexidine and alholic solution dicluconate cloehexidine and potassium sorbate

Hand antisepsis with Clorhexidina and solution; Hand antisepsis with propanolol-1 60%

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants without systemic pathologies, with healthy skin of the hands and short fingernails.
• They do not use substances with antibacterial action.

You may not qualify if:

• Taken antibiotics before 10 days of the intervention.
• Wear any jewellery on the hands

Sponsors & Collaborators

• Centro Ortopedico y Quirurgico del Pie: lead

Study Sites (1)

Centro ortopedico y quirurgico del pie

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Interventions

Solutions; Sorbic Acid

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Ricardo Becerro de Bengoa Vallejo

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The samples will be sent to the laboratory with numbers
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Crossover Assignment Crossover design is used

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 1, 2020
• Study Start: July 12, 2020
• Primary Completion: July 18, 2020
• Study Completion: August 15, 2020
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)