Residual Effect of Chlorhexidine-alcohol Compared to Triclosan-alcohol

NCT01762904 | Completed Phase 3 Results

• 1 other identifier: 385-12
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Diseases

Keywords

Antiseptics; Administration cutaneously; Anti-infecting agents, local

Outcome Measures

Primary Outcomes (3)

• Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically

  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.

  24 hours

• Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically.

  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.

  24 hours

• Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab

  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.

  24 hrs

Secondary Outcomes (1)

• Detect Presence of Allergy or Skin Reaction by the Antiseptic Application

  24 hours

Study Arms (1)

Whole group of 135 units of measurement

EXPERIMENTAL

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

Interventions

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

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.

Also known as: - Neutralizing agar (D/E neutralizing Agar, Difco TM), - Neutralizing broth (D/E Neutralizing Broth, Difco TM)

Whole group of 135 units of measurement

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

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.

Also known as: - 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

Whole group of 135 units of measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Guanajuato: lead
• Antisepsia Central: collaborator

Study Sites (1)

University of Guanajuato

León, Guanajuato, 37000, Mexico

Location

Related Publications (33)

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MeSH Terms

Conditions

Communicable Diseases

Interventions

chlorhexidine gluconate; 2-Propanol; Triclosan

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Alejandro E. Macías
• Organization: Universidad de Guanajuato

aaeemmhh@yahoo.com

+52 477 7 14 58 59

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: January 8, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 2, 2014
• Results First Posted: July 2, 2014

Record last verified: 2014-06

Locations

ME (1)