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

NCT02833376 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-12-13

No results posted yet for this study

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

Interventions

OTHER

alcohol antisepsis

OTHER

chlorhexidine antisepsis

Sponsors & Collaborators

  • Universidade do Vale do Sapucai

    lead OTHER

Principal Investigators

  • Daniela F Veiga, MD, PhD · Universidade do Vale do Sapucai

  • Ana Beatriz A Loyola, PhD · Universidade do Vale do Sapucai

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-30
Primary Completion
2017-01-06
Completion
2017-01-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02833376 on ClinicalTrials.gov