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

Sponsor

Universidade do Vale do Sapucai (Other)

Overall Status

Completed

CT.gov ID

NCT02833376

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Spinal Anesthesia, Epidural Antisepsis	Other: alcohol antisepsis Other: chlorhexidine antisepsis	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 30, 2016

Actual Primary Completion Date :

Jan 6, 2017

Actual Study Completion Date :

Jan 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alcohol group Patients allocated to this group will receive skin antisepsis with alcohol 70% prior spinal anesthesia	Other: alcohol antisepsis
Experimental: Chlorhexidine group Patients allocated to this group will receive skin antisepsis with alcoholic solution of chlorhexidine 0.5% prior spinal anesthesia	Other: chlorhexidine antisepsis

Arm

Intervention/Treatment

Experimental: Alcohol group

Patients allocated to this group will receive skin antisepsis with alcohol 70% prior spinal anesthesia

Other: alcohol antisepsis

Experimental: Chlorhexidine group

Patients allocated to this group will receive skin antisepsis with alcoholic solution of chlorhexidine 0.5% prior spinal anesthesia

Other: chlorhexidine antisepsis

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital e Maternidade Santa Paula	Pouso Alegre	Minas Gerais	Brazil	37550-000

Sponsors and Collaborators

Universidade do Vale do Sapucai

Investigators

Study Chair: Daniela F Veiga, MD, PhD, Universidade do Vale do Sapucai
Study Director: Ana Beatriz A Loyola, PhD, Universidade do Vale do Sapucai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luiz Carlos Tostes, MD, Universidade do Vale do Sapucai

ClinicalTrials.gov Identifier:

NCT02833376

Other Study ID Numbers:

MPLCT

First Posted:

Jul 14, 2016

Last Update Posted:

Dec 13, 2017

Last Verified:

Jul 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Luiz Carlos Tostes, MD, Universidade do Vale do Sapucai

microbiota

ethanol

chlorhexidine

Additional relevant MeSH terms:

Chlorhexidine

Study Results

No Results Posted as of Dec 13, 2017