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NCT Number: NCT01762904

Residual Effect of Chlorhexidine-alcohol Compared to Triclosan-alcohol

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.

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Key information

Conditions

Infectious Diseases Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Guanajuato

León, Guanajuato, 37000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: - Neutralizing agar (D/E neutralizing Agar, Difco TM), - Neutralizing broth (D/E Neutralizing Broth, Difco TM)

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.

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad de Guanajuato

Other

Collaborators

  • Antisepsia Central

Registry information

Official study title

Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Compared to Triclosan 1% / Isopropyl Alcohol 70%

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 8, 2013
Registry last updated
Jul 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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