Residual Effect of Chlorhexidine-alcohol Compared to Triclosan-alcohol

This study has been completed.
Sponsor:
Collaborator:
Antisepsia Central
Information provided by (Responsible Party):
Alejandro E. Macias, Universidad de Guanajuato
ClinicalTrials.gov Identifier:
NCT01762904
First received: January 2, 2013
Last updated: June 1, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Infectious Diseases
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
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Compared to Triclosan 1% / Isopropyl Alcohol 70%

Resource links provided by NLM:


Further study details as provided by Universidad de Guanajuato:

Primary Outcome Measures:
  • Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

    135 determinations to evaluate residual effect of 2% chlorhexidine in 70% isopropyl alcohol.

    All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.

    Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.


  • Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

    135 determinations to test 1% triclosan in 70% isopropyl alcohol.

    All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 1% triclosan in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.

    Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.


  • Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]

    135 units of measurement to test two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.

    All volunteers was provided with a neutral soap without antiseptics for use of two weeks. Deionized water redistilled (Control 2: Control with scrub) and Scrub the skin without prior application of any substance (Control1: Control without scrub) was tested. Were prepared two skin's areas of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h.

    Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.



Secondary Outcome Measures:
  • Detect Presence of Allergy or Skin Reaction by the Antiseptic Application [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

    135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.

    All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. We prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h.

    Presence of allergy or any skin reaction at 24 hours after the antiseptic application.



Enrollment: 135
Study Start Date: January 2013
Study Completion Date: October 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Whole group of 135 units of measurement

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
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 Names:
  • - Neutralizing agar (D/E neutralizing Agar, Difco TM)
  • - Neutralizing broth (D/E Neutralizing Broth, Difco TM)
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.
Other Names:
  • - 2% chlorhexidine gluconate in 70% isopropyl alcohol
  • - 1% triclosan in 70% isopropyl alcohol
  • - Scrub the skin without prior application of any substance
  • - Deionized water redistilled

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762904

Locations
Mexico
University of Guanajuato
Leon, Guanajuato, Mexico, 37000
Sponsors and Collaborators
Universidad de Guanajuato
Antisepsia Central
  More Information

Publications:
Newman JL, Kaiser NE. Extended activity of healthcare antiseptic products: Manivannan G. Disinfection and decontamination, Principles, applications and related issues. 1st Edition, St. Louis, Missouri, USA. CRC Press Editorial, 2007, Oct: 155-152
Anderson KF. Antibacterial bacteriological swabs. Br Med J. 1965;2:1123-1124.

Responsible Party: Alejandro E. Macias, Principal Investigator, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT01762904     History of Changes
Other Study ID Numbers: 385-12
Study First Received: January 2, 2013
Results First Received: June 1, 2014
Last Updated: June 1, 2014
Health Authority: Mexico: University of Guanajuato

Keywords provided by Universidad de Guanajuato:
Antiseptics
Administration cutaneously
Anti-infecting agents, local

Additional relevant MeSH terms:
Communicable Diseases
Infection
Ethanol
Anti-Infective Agents, Local
Chlorhexidine
Chlorhexidine gluconate
Triclosan
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Disinfectants
Dermatologic Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 24, 2014