Residual Effect of Chlorhexidine-alcohol Compared to Triclosan-alcohol

• ClinicalTrials.gov Identifier: NCT01762904
• Recruitment Status: Completed
• First Posted: January 8, 2013
• Results First Posted: July 2, 2014
• Last Update Posted: July 2, 2014
• Sponsor: Universidad de Guanajuato
• Collaborator: Antisepsia Central
• Information provided by (Responsible Party): Alejandro E. Macias, Universidad de Guanajuato

Study Description

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.

Condition or disease	Intervention/treatment	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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 135 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Compared to Triclosan 1% / Isopropyl Alcohol 70%
• Study Start Date: January 2013
• Actual Primary Completion Date: April 2013
• Actual Study Completion Date: October 2013

Arms and Interventions

Arm

Intervention/treatment

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

Outcome Measures

Primary Outcome Measures :

1. Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically [ Time Frame: 24 hours ]

   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.

2. Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically. [ Time Frame: 24 hours ]

   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.

3. Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab [ Time Frame: 24 hrs ]

   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 :

1. Detect Presence of Allergy or Skin Reaction by the Antiseptic Application [ Time Frame: 24 hours ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Mexico

University of Guanajuato

Leon, Guanajuato, Mexico, 37000

Sponsors and Collaborators

Universidad de Guanajuato

Antisepsia Central

More Information

Publications:

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Edmiston CE Jr, Seabrook GR, Johnson CP, Paulson DS, Beausoleil CM. Comparative of a new and innovative 2% chlorhexidine gluconate-impregnated cloth with 4% chlorhexidine gluconate as topical antiseptic for preparation of the skin prior to surgery. Am J Infect Control. 2007 Mar;35(2):89-96.

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• Responsible Party: Alejandro E. Macias, Principal Investigator, Universidad de Guanajuato
• ClinicalTrials.gov Identifier: NCT01762904
• Other Study ID Numbers: 385-12
• First Posted: January 8, 2013
• Results First Posted: July 2, 2014
• Last Update Posted: July 2, 2014
• Last Verified: June 2014

Keywords provided by Alejandro E. Macias, Universidad de Guanajuato:

Antiseptics; Administration cutaneously; Anti-infecting agents, local

Additional relevant MeSH terms:

Communicable Diseases; Infections; Disease Attributes; Pathologic Processes; Ethanol; Chlorhexidine; Chlorhexidine gluconate; Triclosan; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Disinfectants; Dermatologic Agents; Fatty Acid Synthesis Inhibitors; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents