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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02833376
Enrollment
70
Registered
2016-07-14
Start date
2016-05-30
Completion date
2017-01-30
Last updated
2017-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Epidural, Anesthesia, Spinal, Antisepsis

Keywords

microbiota, ethanol, chlorhexidine

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.

Interventions

OTHERalcohol antisepsis
OTHERchlorhexidine antisepsis

Sponsors

Universidade do Vale do Sapucai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026