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Completed

NCT Number: NCT02833376

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

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.

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Key information

Conditions

Anesthesia, Spinal Anesthesia, Epidural Antisepsis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital e Maternidade Santa Paula

Pouso Alegre, Minas Gerais, 37550-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

alcohol antisepsis

Other

chlorhexidine antisepsis

Other

Primary outcomes

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

    Time frame: Before antisepsis

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

    Time frame: 2 minutes after antisepsis

    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)

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

    Time frame: After the Puncture and at most 40 minutes

    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)

Sponsors and collaborators

Lead sponsor

Universidade do Vale do Sapucai

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2016
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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