Chlorhexidine Against Sodium Hypochlorite as Skin Antiseptics

Universidad de Guanajuato

Status and phase: Completed; Phase 3

Conditions: Infectious Diseases

Treatments: Biological: Antiseptic substantivity; Other: Preparing skin's areas to be tested; Biological: Bacterial culture of the prepared skin's areas

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01321125

2011UGTO372

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult volunteers

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Whole group of 30 volunteers

Experimental group

Description:

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.

Treatment:

Biological: Bacterial culture of the prepared skin's areas

Other: Preparing skin's areas to be tested

test group of substantivity

Experimental group

Description:

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)

Treatment:

Biological: Antiseptic substantivity