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

Anesthesia, Spinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02833376
• Other study ID #: MPLCT
• Status: Completed
• Phase: N/A
• First received: July 5, 2016
• Last updated: December 11, 2017
• Start date: May 30, 2016
• Est. completion date: January 30, 2017

Study information

• Verified date: July 2016
• Source: Universidade do Vale do Sapucai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 30, 2017
• Est. primary completion date: January 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Epidural
• Anesthesia, Spinal
• Antisepsis

Intervention

Other:
• alcohol antisepsis

• chlorhexidine antisepsis

Locations

Country	Name	City	State
Brazil	Hospital e Maternidade Santa Paula	Pouso Alegre	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Sapucai

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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