Chlorhexidine Against Sodium Hypochlorite as Skin Antiseptics

Phase 3

Completed

• Conditions: Infectious Diseases
• Interventions: Biological: Antiseptic substantivity; Biological: Bacterial culture of the prepared skin's areas; Other: Preparing skin's areas to be tested

• Registration Number: NCT01321125
• Lead Sponsor: Universidad de Guanajuato

Brief Summary

The physicians have few options for skin antisepsis. Alternatives for common use antiseptics are costly or ineffective. In order to have more options, this study is needed. The investigators want to know if there are differences between the use of 2% chlorhexidine gluconate in 70% isopropyl alcohol or 10% sodium hypochlorite.

Detailed Description

Sodium hypochlorite at 10% has been widely used as antiseptic in patients on dialysis as well as for irrigation of wounds and burns. Since it has been used successfully in caring for the exit side of hemodialysis catheters, it is reasonable to propose its use for the insertion and care of central intravascular catheters, as well as for skin preparation before surgery. Alternatives for povidone-iodine, which is the agent most commonly used, are costly or ineffective. In a recent study perform by our group it was demonstrated that 10% sodium hypochlorite was not inferior than povidone-iodine.

It has been demonstrated as well that 2% chlorhexidine gluconate in 70% isopropyl alcohol is superior to povidone-iodine. The aim of this study is to know if 10% sodium hypochlorite has a similar effect that the best current option for skin antisepsis.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Study Start: 2011-04
• Status Verified: 2011-09
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Last Update Submitted: 2013-06-20
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Healthy adult volunteers

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Exclusion Criteria

• History of skin allergies or atopy, as well as reactions to soaps, chlorine or latex

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
test group of substantivity	Antiseptic substantivity	The arm is composed of 10 human volunteers to test 2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep ®, Enturia, Texas, USA ), hypochlorite 10% of electrochemical production (Except 10% ®, Pisa, Guadalajara, Mexico), and 10% povidone-iodine (Isodine Solucion ®, Boehringer-Ingelheim Promeco, Mexico City)
Whole group of 30 volunteers	Bacterial culture of the prepared skin's areas	The arm is composed of 30 human volunteers to test 2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep ®, Enturia, Texas, USA ), hypochlorite 10% of electrochemical production (Except 10% ®, Pisa, Guadalajara, Mexico), and two controls.
Whole group of 30 volunteers	Preparing skin's areas to be tested	The arm is composed of 30 human volunteers to test 2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep ®, Enturia, Texas, USA ), hypochlorite 10% of electrochemical production (Except 10% ®, Pisa, Guadalajara, Mexico), and two controls.

Primary Outcome Measures

Name	Time	Method
Comparison of the efficacy of 2% chlorhexidine gluconate in 70% isopropyl alcohol and 10% sodium hypochlorite	24 hours	Compare decrease in colony forming units in cultures of samples taken with both antiseptics

Secondary Outcome Measures

Name	Time	Method
Presence of skin reactions for the 2% chlorhexidine gluconate in 70% isopropyl alcohol	24 hours	Presence of allergy or any reaction at 24 hours after the antiseptic application.
Bacterial count of skin cultures for the control 1	24 hours	Scrub with saline solution. Bacterial colony count of skin cultures to determine antiseptic properties. After incubation, a blinded technician will count the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
Presence of allergy or any reaction at 24 hours after the antiseptic application.	24 hours	Presence of allergy or any reaction at 24 hours after the antiseptic application.
Bacterial count of skin cultures for the 2% chlorhexidine gluconate in 70% isopropyl alcohol	24 hours	Bacterial colony count of skin cultures to determine antiseptic properties. After incubation, a blinded technician will count the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
Bacterial count of skin cultures for the 10% sodium hypochlorite	24 hours	Bacterial colony count of skin cultures to determine antiseptic properties. After incubation, a blinded technician will count the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
Bacterial count of skin cultures for the control 2	24 hours	Sample taken without wash. Bacterial colony count of skin cultures to determine antiseptic properties. After incubation, a blinded technician will count the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
Evaluation of antiseptic substantivity	24 hours	Explore the extended antiseptic activity provide by 2% chlorhexidine gluconate in 70% isopropyl alcohol, 10% sodium hypochlorite and 10% povidone-iodine, by evaluating bacterial grow inhibition in an agar plate.

Trial Locations

Locations (1)

University of Guanajuato School of Medicine; 🇲🇽 Leon, Guanajuato, Mexico