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Completed

NCT Number: NCT01361997

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

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.

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Key information

Conditions

Infectious Diseases Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Guanajuato School of Medicine

León, Guanajuato, 37000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

chlorhexidine in isopropyl alcohol

Biological

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.

Other names: Chloraprep, Enturia Inc., Texas., BacT/ALERT FA, Biomérieux Inc., North Carolina.

Isopropyl alcohol

Biological

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.

Other names: Alcohol Swabs, BD, Madrid., BacT/ALERT FA, Biomérieux Inc., North Carolina.

Primary outcomes

  1. Determine if 70% isopropyl alcohol is not inferior preventing contamination of peripheral hemoculture, compared with 2% chlorhexidine in 70% isopropyl alcohol.

    Time frame: 120 hours

    It will determine the growth of contaminating germs in hemocultures taken with each antiseptic tested.

Secondary outcomes

  1. Determine the rate of contamination of each antiseptic used.

    Time frame: 1 year

    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.

  2. Description of the most frequent bacterial contaminants.

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Universidad de Guanajuato

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 27, 2011
Registry last updated
Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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