Residual Effect of Chlorhexidine-alcohol Compared to Triclosan-alcohol

Universidad de Guanajuato

Status and phase: Completed; Phase 3

Conditions: Infectious Diseases

Treatments: Other: Bacterial culture of the prepared skin's areas with two antiseptics and two controls; Other: Preparing skin's areas to be tested with two antiseptics and two controls

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01762904

385-12

Details and patient eligibility

About

Currently there are few options for skin antisepsis, commercially antiseptic triclosan is mainly used. To have more options, this study is necessary, where investigators will determine the residual effect of 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and choose the one with the best characteristics for skin antisepsis.

Full description

2% chlorhexidine has been used as an antiseptic for invasive procedures, such as the skin preparation for surgery or insertion of intravascular catheters, thereby decreasing the incidence of infections. The preparation of the skin with antiseptics, helps mechanically clean the surface of the skin to be subjected to surgical intervention, removing fat, sweat, dead cells and kill bacteria that are in the skin. It has been shown that 2% chlorhexidine in solution with 70% isopropyl alcohol has greater activity than chlorhexidine in aqueous solution. The constant use of triclosan causes resistance of some microorganisms on some antibiotics.It has been shown that 0.5% of triclosan in 60% alcohol isopropyl chlorhexidine is more effective than alcohol. The aim of the study is to know if 2% chlorhexidine has more residual effect than triclosan 1%, both antiseptic diluted in 70% isopropyl alcohol.

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult volunteers
• Volunteers who have completed the stabilization phase of skin flora.
• Volunteers who does not taken a shower or bath 24 hours before the test.

Exclusion criteria

• Volunteers with a score below 100 Colony Forming Unit per square centimeter (CFU/cm2) of forearm skin surface in the control after the stabilization of the skin flora.
• History of skin allergies or atopy, as well as reactions to alcohol, soaps, iodine, chlorine or latex.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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135 participants in 1 patient group

Whole group of 135 units of measurement

Experimental group

Description:

The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls. The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination. Interventions: * Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls * Other: Preparing skin's areas to be tested with two antiseptics and two controls

Treatment:

Other: Preparing skin's areas to be tested with two antiseptics and two controls

Other: Bacterial culture of the prepared skin's areas with two antiseptics and two controls