Chlorhexidine Against Sodium Hypochlorite as Skin Antiseptics - Full Text View

Purpose

The physicians have few options for skin antisepsis. Alternatives for common use antiseptics are costly or ineffective. In order to have more options, this study is needed. The investigators want to know if there are differences between the use of 2% chlorhexidine gluconate in 70% isopropyl alcohol or 10% sodium hypochlorite.

Condition	Intervention	Phase
Infectious Diseases	Biological: Bacterial culture of the prepared skin's areas Other: Preparing skin's areas to be tested Biological: Antiseptic substantivity	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Comparative Study of 2% Chlorhexidine Gluconate in 70% Isopropyl Alcohol Against 10% Sodium Hypochlorite as Skin Antiseptics in Human Volunteers

Resource links provided by NLM:

Drug Information available for: Chlorhexidine Isopropyl alcohol Sodium gluconate Manganese gluconate Iodine Sodium hypochlorite Chlorhexidine gluconate Iodide Povidone-iodine Hibiclens

U.S. FDA Resources

Further study details as provided by Universidad de Guanajuato:

Primary Outcome Measures:

Comparison of the efficacy of 2% chlorhexidine gluconate in 70% isopropyl alcohol and 10% sodium hypochlorite [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Compare decrease in colony forming units in cultures of samples taken with both antiseptics

Secondary Outcome Measures:

Presence of skin reactions for the 2% chlorhexidine gluconate in 70% isopropyl alcohol [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Presence of allergy or any reaction at 24 hours after the antiseptic application.
Presence of allergy or any reaction at 24 hours after the antiseptic application. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Presence of allergy or any reaction at 24 hours after the antiseptic application.
Bacterial count of skin cultures for the 2% chlorhexidine gluconate in 70% isopropyl alcohol [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Bacterial colony count of skin cultures to determine antiseptic properties. After incubation, a blinded technician will count the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
Bacterial count of skin cultures for the 10% sodium hypochlorite [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Bacterial colony count of skin cultures to determine antiseptic properties. After incubation, a blinded technician will count the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
Bacterial count of skin cultures for the control 1 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Scrub with saline solution. Bacterial colony count of skin cultures to determine antiseptic properties. After incubation, a blinded technician will count the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
Bacterial count of skin cultures for the control 2 [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Sample taken without wash. Bacterial colony count of skin cultures to determine antiseptic properties. After incubation, a blinded technician will count the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
Evaluation of antiseptic substantivity [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Explore the extended antiseptic activity provide by 2% chlorhexidine gluconate in 70% isopropyl alcohol, 10% sodium hypochlorite and 10% povidone-iodine, by evaluating bacterial grow inhibition in an agar plate.

Enrollment:	30
Study Start Date:	April 2011
Study Completion Date:	January 2012
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Whole group of 30 volunteers The arm is composed of 30 human volunteers to test 2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep ®, Enturia, Texas, USA ), hypochlorite 10% of electrochemical production (Except 10% ®, Pisa, Guadalajara, Mexico), and two controls.	Biological: Bacterial culture of the prepared skin's areas Cultures were taken with a scrub-cup of 5cm2 of internal area pressed over the skin previously prepared, then it was added a 3mL of culture broth (C/E neutralizing broth (D/E Neutralizing Broth, DIFCO TM) containing a neutralizing agent and a detergent agent (1% solution tween-80) as washing solution. The skin was scrub with a sterile rubber policeman for 2 minutes, and the procedure was conducted once again. Both aliquots were gathered together in a sterile tube, and a sample of 50mL was spread in a plate containing a neutralizing agar (D/E neutralizing Agar, DIFCO TM) and incubated at 35°C for 72 hrs. After incubation, the colonies were counted. Other Names: Neutralizing agar Neutralizing broth Other: Preparing skin's areas to be tested Two antiseptics (2% chlorhexidine gluconate in 70% isopropyl alcohol and 10% sodium hypochlorite) and two controls were tested as skin antiseptics. The intervention consisted of preparing four skin's areas with the antiseptic or the control, two in each arm of the volunteer. These ones were approximately 25cm2 on the forearm for each antiseptic or control. The antiseptic or control were applied in an outward circular motion using a swab that was soaked with the solution. The solution was kept on the skin for 60 seconds before the bacterial culture was conducted. Every volunteer were studied in three separate occasions, alternating the four areas in every subsequent test, so every area was studied with each control or antiseptic. Other Names: Chloraprep (R) Except (R)
Experimental: test group of substantivity The arm is composed of 10 human volunteers to test 2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep ®, Enturia, Texas, USA ), hypochlorite 10% of electrochemical production (Except 10% ®, Pisa, Guadalajara, Mexico), and 10% povidone-iodine (Isodine Solucion ®, Boehringer-Ingelheim Promeco, Mexico City)	Biological: Antiseptic substantivity Three antiseptics will be tested: 2% chlorhexidine gluconate in 70% isopropyl alcohol, 10% sodium hypochlorite and 10% povidone-iodine, each one will be applied on the surface of one fingertip each, and will be allow to dry for 60 seconds, then the remaining antiseptic on the skin will be wash out with distilled water. The evaluated zones will be dried with sterile gauze, and then will be covered with sterile gauze for two hours. After this period, each finger will be placed for 30 seconds on an agar plate, which will be inoculated whit an ATCC E. coli. The plate will be incubated at 35ºC for 72 hrs. After incubation, a blinded technician will report the presence or absence of bacterial growth Other Names: 2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep ®, Enturia, Texas, USA ) hypochlorite 10% of electrochemical production (Except 10% ®, Pisa, Guadalajara, Mexico) 10% povidone-iodine (Isodine Solucion ®, Boehringer-Ingelheim Promeco, Mexico City) Muller Hinton agar plate (BD/BBL ™, México City, México).

Arms

Assigned Interventions

Experimental: Whole group of 30 volunteers

The arm is composed of 30 human volunteers to test 2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep ®, Enturia, Texas, USA ), hypochlorite 10% of electrochemical production (Except 10% ®, Pisa, Guadalajara, Mexico), and two controls.

Biological: Bacterial culture of the prepared skin's areas

Cultures were taken with a scrub-cup of 5cm2 of internal area pressed over the skin previously prepared, then it was added a 3mL of culture broth (C/E neutralizing broth (D/E Neutralizing Broth, DIFCO TM) containing a neutralizing agent and a detergent agent (1% solution tween-80) as washing solution. The skin was scrub with a sterile rubber policeman for 2 minutes, and the procedure was conducted once again. Both aliquots were gathered together in a sterile tube, and a sample of 50mL was spread in a plate containing a neutralizing agar (D/E neutralizing Agar, DIFCO TM) and incubated at 35°C for 72 hrs. After incubation, the colonies were counted.

Other Names:

Neutralizing agar
Neutralizing broth

Other: Preparing skin's areas to be tested

Two antiseptics (2% chlorhexidine gluconate in 70% isopropyl alcohol and 10% sodium hypochlorite) and two controls were tested as skin antiseptics. The intervention consisted of preparing four skin's areas with the antiseptic or the control, two in each arm of the volunteer. These ones were approximately 25cm2 on the forearm for each antiseptic or control. The antiseptic or control were applied in an outward circular motion using a swab that was soaked with the solution. The solution was kept on the skin for 60 seconds before the bacterial culture was conducted. Every volunteer were studied in three separate occasions, alternating the four areas in every subsequent test, so every area was studied with each control or antiseptic.

Other Names:

Chloraprep (R)
Except (R)

Experimental: test group of substantivity

The arm is composed of 10 human volunteers to test 2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep ®, Enturia, Texas, USA ), hypochlorite 10% of electrochemical production (Except 10% ®, Pisa, Guadalajara, Mexico), and 10% povidone-iodine (Isodine Solucion ®, Boehringer-Ingelheim Promeco, Mexico City)

Biological: Antiseptic substantivity

Three antiseptics will be tested: 2% chlorhexidine gluconate in 70% isopropyl alcohol, 10% sodium hypochlorite and 10% povidone-iodine, each one will be applied on the surface of one fingertip each, and will be allow to dry for 60 seconds, then the remaining antiseptic on the skin will be wash out with distilled water. The evaluated zones will be dried with sterile gauze, and then will be covered with sterile gauze for two hours. After this period, each finger will be placed for 30 seconds on an agar plate, which will be inoculated whit an ATCC E. coli. The plate will be incubated at 35ºC for 72 hrs. After incubation, a blinded technician will report the presence or absence of bacterial growth

Other Names:

2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep ®, Enturia, Texas, USA )
hypochlorite 10% of electrochemical production (Except 10% ®, Pisa, Guadalajara, Mexico)
10% povidone-iodine (Isodine Solucion ®, Boehringer-Ingelheim Promeco, Mexico City)
Muller Hinton agar plate (BD/BBL ™, México City, México).

Detailed Description:

Sodium hypochlorite at 10% has been widely used as antiseptic in patients on dialysis as well as for irrigation of wounds and burns. Since it has been used successfully in caring for the exit side of hemodialysis catheters, it is reasonable to propose its use for the insertion and care of central intravascular catheters, as well as for skin preparation before surgery. Alternatives for povidone-iodine, which is the agent most commonly used, are costly or ineffective. In a recent study perform by our group it was demonstrated that 10% sodium hypochlorite was not inferior than povidone-iodine.

It has been demonstrated as well that 2% chlorhexidine gluconate in 70% isopropyl alcohol is superior to povidone-iodine. The aim of this study is to know if 10% sodium hypochlorite has a similar effect that the best current option for skin antisepsis.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adult volunteers

Exclusion Criteria:

History of skin allergies or atopy, as well as reactions to soaps, chlorine or latex

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01321125

Locations

Mexico
University of Guanajuato School of Medicine
Leon, Guanajuato, Mexico, 37000

Sponsors and Collaborators

Universidad de Guanajuato

G70 antisepsis

Investigators

Principal Investigator:

Alejandro E Macias, M. D.

University of Guanajuato

More Information

No publications provided

Responsible Party:	Alejandro E. Macias, MD, Universidad de Guanajuato
ClinicalTrials.gov Identifier:	NCT01321125 History of Changes
Other Study ID Numbers:	2011UGTO372
Study First Received:	March 22, 2011
Last Updated:	August 11, 2012
Health Authority:	Mexico: Secretaria de Salud

Keywords provided by Universidad de Guanajuato:

Antiseptics
Administration cutaneously
Chlorine compounds
Anti-infecting agents, local

Additional relevant MeSH terms:

Communicable Diseases
Infection
Ethanol
Anti-Infective Agents, Local
Chlorhexidine
Chlorhexidine gluconate
Iodine
Povidone-Iodine
Eusol
Sodium Hypochlorite
Povidone
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Disinfectants
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Dermatologic Agents
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013