Clinical trial NCT01762904: Residual Effect of Chlorhexidine-alcohol Compared to Triclosan-alcohol
Official title: Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Compared to Triclosan 1% / Isopropyl Alcohol 70%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infectious Diseases
Keywords: Antiseptics
Administration cutaneously
Anti-infecting agents, local
Lead sponsor: Universidad de Guanajuato
Sponsor class: OTHER
Collaborators: name: Antisepsia Central
First posted: 2013-01-08
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically
timeFrame: 24 hours
measure: Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically.
timeFrame: 24 hours
measure: Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab
timeFrame: 24 hrs
Secondary outcomes:
measure: Detect Presence of Allergy or Skin Reaction by the Antiseptic Application
timeFrame: 24 hours
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: University of Guanajuato
state: Guanajuato
Study officials:
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