Alcohol 70% Versus Chlorhexidine 0.5% in the Spinal Anesthesia Skin Antissepsis

NCT02833376 | Completed

• 1 other identifier: MPLCT
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Context: The neuraxial blocks, spinal anesthesia and epidural anesthesia are among the most frequently performed procedures worldwide, and despite the advancements of medical equipment, remain dependent on experience and practice of the anesthesiologists. Although antisepsis takes part of the daily routine, there are still no solid scientific evidence of the most appropriate antiseptic for these procedures. Objective: To compare the 70% alcohol and 0.5% chlorhexidine alcohol solution in skin antisepsis for the neuraxial blocks. Methods: This is a clinical trial, a prospective, randomized study. There will be selected, consecutively, 70 patients candidates for neuraxial blocks. Patients will be randomly assigned to group A (n = 35), in which the antisepsis will be performed with alcohol 70%, and to group B (n = 35), in which the antiseptic will be performed with the 0.5% chlorhexidine in alcoholic solution. Samples will be collected with swabs in an area of 25 cm² for bacterial cultures three times: in pre-antisepsis moments, in the second minute after antisepsis, and immediately after the puncture. The number of colonies forming units per square centimeter (CFU / cm²) will be counted. The data will be analyzed statistically.

Conditions

Anesthesia, Spinal; Anesthesia, Epidural; Antisepsis

Keywords

microbiota; ethanol; chlorhexidine

Outcome Measures

Primary Outcomes (3)

• Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)

  The material will be collected in a pre determined field of 25 cm², with a swab, and the maximum seeding in 8 hours, 48 hours after will be counted the number of colonies forming units per square centimeter (CFU/cm²)

  Before antisepsis

• Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)

  The material will be collected in a pre determined field of 25 cm², with a swab, and the maximum seeding in 8 hours, 48 hours after will be counted the number of colonies forming units per square centimeter (CFU/cm²)

  2 minutes after antisepsis

• Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)

  The material will be collected in a pre determined field of 25 cm², with a swab, and the maximum seeding in 8 hours, 48 hours after will be counted the number of colonies forming units per square centimeter (CFU/cm²)

  After the Puncture and at most 40 minutes

Study Arms (2)

Alcohol group

EXPERIMENTAL

Patients allocated to this group will receive skin antisepsis with alcohol 70% prior spinal anesthesia

Other: alcohol antisepsis

Chlorhexidine group

EXPERIMENTAL

Patients allocated to this group will receive skin antisepsis with alcoholic solution of chlorhexidine 0.5% prior spinal anesthesia

Other: chlorhexidine antisepsis

Interventions

alcohol antisepsis OTHER

Alcohol group

chlorhexidine antisepsis OTHER

Chlorhexidine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 and 65 years of age , without restriction as to sex, ethnicity, education or social class;
• Patients who are undergoing neuraxial blockade by indicating the anesthesiologist responsible for the procedure

You may not qualify if:

• comorbidities or conditions which constitute a contraindication for the neuroaxial block ;
• Body mass index (BMI ) greater than 30 kg / m2;
• Ongoing infection;
• Use of antibiotics in the last seven days;
• Skin lesions at the puncture site ;
• Refusal to participate.

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Hospital e Maternidade Santa Paula

Pouso Alegre, Minas Gerais, 37550-000, Brazil

Location

Related Publications (1)

• Tostes LCS, Loyola ABAT, Fraga AO, Gazzi LA, Paiva LF, Juliano Y, Veiga DF. Alcohol (70%) versus alcoholic chlorhexidine solution (0.5%) in skin antisepsis for neuraxial blocks: a randomized clinical trial. Rev Col Bras Cir. 2021 Jan 13;48:e20202633. doi: 10.1590/0100-6991e-20202633. eCollection 2021.

  PMID: 33470369 DERIVED

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Daniela F Veiga, MD, PhD

  Universidade do Vale do Sapucai

  STUDY CHAIR

• Ana Beatriz A Loyola, PhD

  Universidade do Vale do Sapucai

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 14, 2016
• Study Start: May 30, 2016
• Primary Completion: January 6, 2017
• Study Completion: January 30, 2017
• Last Updated: December 13, 2017

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)