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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcohol group | Experimental | Patients allocated to this group will receive skin antisepsis with alcohol 70% prior spinal anesthesia |
|
| Chlorhexidine group | Experimental | Patients allocated to this group will receive skin antisepsis with alcoholic solution of chlorhexidine 0.5% prior spinal anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alcohol antisepsis | Other |
| ||
| chlorhexidine antisepsis |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniela F Veiga, MD, PhD | Universidade do Vale do Sapucai | Study Chair |
| Ana Beatriz A Loyola, PhD | Universidade do Vale do Sapucai | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital e Maternidade Santa Paula | Pouso Alegre | Minas Gerais | 37550-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33470369 | Derived | 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. |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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