Residual Effect of Chlorhexidine-alcohol Compared to Triclosan-alcohol

Infectious Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01762904
• Other study ID #: 385-12
• Status: Completed
• Phase: Phase 3
• First received: January 2, 2013
• Last updated: June 1, 2014
• Start date: January 2013
• Est. completion date: October 2013

Study information

• Verified date: June 2014
• Source: Universidad de Guanajuato
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: University of Guanajuato
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infectious Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Mexico	University of Guanajuato	Leon	Guanajuato

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Guanajuato	Antisepsia Central

Country where clinical trial is conducted

Mexico, 

References & Publications (33)

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Bedoux G, Roig B, Thomas O, Dupont V, Le Bot B. Occurrence and toxicity of antimicrobial triclosan and by-products in the environment. Environ Sci Pollut Res Int. 2012 May;19(4):1044-65. doi: 10.1007/s11356-011-0632-z. Epub 2011 Nov 5. Review. — View Citation

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Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988. — View Citation

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Eiselt D. Presurgical skin preparation with a novel 2% chlorhexidine gluconate cloth reduces rates of surgical site infection in orthopaedic surgical patients. Orthop Nurs. 2009 May-Jun;28(3):141-5. doi: 10.1097/NOR.0b013e3181a469db. — View Citation

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Hibbard JS, Mulberry GK, Brady AR. A clinical study comparing the skin antisepsis and safety of ChloraPrep, 70% isopropyl alcohol, and 2% aqueous chlorhexidine. J Infus Nurs. 2002 Jul-Aug;25(4):244-9. — View Citation

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Karpanen TJ, Worthington T, Conway BR, Hilton AC, Elliott TS, Lambert PA. Penetration of chlorhexidine into human skin. Antimicrob Agents Chemother. 2008 Oct;52(10):3633-6. doi: 10.1128/AAC.00637-08. Epub 2008 Aug 1. — View Citation

Karpanen TJ, Worthington T, Hendry ER, Conway BR, Lambert PA. Antimicrobial efficacy of chlorhexidine digluconate alone and in combination with eucalyptus oil, tea tree oil and thymol against planktonic and biofilm cultures of Staphylococcus epidermidis. J Antimicrob Chemother. 2008 Nov;62(5):1031-6. doi: 10.1093/jac/dkn325. Epub 2008 Aug 13. — View Citation

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Malhotra S, Dharmadasa A, Yentis SM. One vs two applications of chlorhexidine/ethanol for disinfecting the skin: implications for regional anaesthesia. Anaesthesia. 2011 Jul;66(7):574-8. doi: 10.1111/j.1365-2044.2011.06706.x. Epub 2011 May 24. — View Citation

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Queckenberg C, Meins J, Wachall B, Doroshyenko O, Tomalik-Scharte D, Bastian B, Abdel-Tawab M, Fuhr U. Absorption, pharmacokinetics, and safety of triclosan after dermal administration. Antimicrob Agents Chemother. 2010 Jan;54(1):570-2. doi: 10.1128/AAC.00615-09. Epub 2009 Oct 12. — View Citation

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Small H, Adams D, Casey AL, Crosby CT, Lambert PA, Elliott T. Efficacy of adding 2% (w/v) chlorhexidine gluconate to 70% (v/v) isopropyl alcohol for skin disinfection prior to peripheral venous cannulation. Infect Control Hosp Epidemiol. 2008 Oct;29(10):963-5. doi: 10.1086/590664. — View Citation

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Detect Presence of Allergy or Skin Reaction by the Antiseptic Application	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.	24 hours	No