Alcohol 70% Versus Chlorhexidine 0.5% in the Spinal Anesthesia Skin Antissepsis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Skin colonization before and after antisepsis, Will be counted number of colonies forming units per square centimeter (CFU/cm²)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Alcohol group
Patients allocated to this group will receive skin antisepsis with alcohol 70% prior spinal anesthesia
Intervention: alcohol antisepsis (Other)
Chlorhexidine group
Patients allocated to this group will receive skin antisepsis with alcoholic solution of chlorhexidine 0.5% prior spinal anesthesia
Intervention: chlorhexidine antisepsis (Other)
Outcomes
Primary Outcomes
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)
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)
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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Luiz Carlos Tostes
MD
Universidade do Vale do Sapucai