Isopropyl Alcohol Against Chlorhexidine - Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determinate if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemocultures, compared with 2% chlorhexidine in 70% isopropyl alcohol.

Detailed Description
-----------------
The develop of contaminants in blood cultures is a problem of great impact to health institutions and patients, as they represent a waste of resources, and additionally increases the patient's hospital stay. The principal source of contaminant is the bacteria in the skin flora, so the greatest way to improve the sensibility of this test is to do an optimal skin antisepsis. It has been reported that 2% chlorhexidine gluconate in 70% isopropyl alcohol is superior that other skin disinfectants, and that 70% isopropyl alcohol has a high efficacy reducing the presence of bacteria on the skin, so both antiseptics are good options for skin antisepsis.

Official Title
-----------------
Comparative Study of 70% Isopropyl Alcohol Against 2% Chlorhexidine- 70% Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination

Conditions
-----------------
Infectious Diseases

Intervention / Treatment
-----------------
* Biological: chlorhexidine in isopropyl alcohol
* Biological: Isopropyl alcohol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected blood stream infection. Patients allocated in admission, hospitalization and intensive care units. Exclusion Criteria: Patients with a single peripheral hemoculture.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine in isopropyl alcohol<br>This arm is composed of 545 hospitalized patients with suspected blood stream infection, to test 2% chlorhexidine gluconate in 70% isopropyl alcohol. | Biological: chlorhexidine in isopropyl alcohol<br>* When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C.<br>* Other names: BacT/ALERT FA, Biomérieux Inc., North Carolina.;|
| Experimental: Isopropyl alcohol<br>This arm is composed of 572 hospitalized patients with suspected blood stream infection, to test 70% isopropyl alcohol. | Biological: Isopropyl alcohol<br>* When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C.<br>* Other names: BacT/ALERT FA, Biomérieux Inc., North Carolina.;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemoculture, compared with 2% chlorhexidine in 70% isopropyl alcohol. | It will determine the growth of contaminating germs in hemocultures taken with each antiseptic tested. | 120 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the rate of contamination of each antiseptic used. | It will determine the rate of contamination at the date of primary completion and the date of study completion. We will consider contaminants the development of Staphylococcus coagulase negative and gram positive bacilli. | 1 year | 
| Description of the most frequent bacterial contaminants. | It will determine the rate of contamination at the date of primary completion and the date of study completion. We will consider contaminants the development of Staphylococcus coagulase negative and gram positive bacilli. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antiseptics, Hemoculture contamination, Anti-infecting agents, local