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Residual Effect of Chlorhexidine-alcohol Compared to Triclosan-alcohol

NCT01762904 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2014-07-02

Study results available
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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.

Conditions

Interventions

OTHER

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

Cultures will be taken with a scrub-cup of 5 cm2 of internal area pressed over the skin previously prepared with the substances, then it added a 3 mL of culture broth (D/E Neutralizing Broth, Difco TM) containing a neutralizing agent as washing solution. The skin will scrub with a sterile rubber policeman for 1 minute and the procedure will be conducted once again. Both aliquots will gather together in a sterile tube, and a sample of 50 microliters will spread in a plate containing a neutralizing agar (D/E neutralizing Agar, Difco TM) and incubate at 35°C for 24 hrs. After incubation, the colonies will be counted.

OTHER

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

All volunteers will be provided with a neutral soap and shampoo without antiseptics for use during a period of two weeks (phase of stabilization of the skin flora). Two antiseptics (2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol) and two controls (Scrub the skin without prior application of any substance and Deionized water redistilled) will be tested as skin antiseptics. The intervention consists of preparing four skin's areas with antiseptics and controls, two in each arm of the volunteer. These ones were approximately 25 cm2 on the forearm for each antiseptic or control. The substances will be applied in an outward circular motion using a sterile swab soaked with the solutions. The solution will remain on the skin for 60 seconds, 3 hours and 24 hours before the bacterial culture will be conducted. For the control where it will be does not apply any substance, the scrub starts immediately.

Sponsors & Collaborators

  • Antisepsia Central

    collaborator INDUSTRY

  • Universidad de Guanajuato

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-04-30
Completion
2013-10-31

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01762904 on ClinicalTrials.gov