Chlorhexidine Against Sodium Hypochlorite as Skin Antiseptics

NCT01321125 | Completed Phase 3

• 1 other identifier: 2011UGTO372
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infectious Diseases

Keywords

Antiseptics; Administration cutaneously; Chlorine compounds; Anti-infecting agents, local

Outcome Measures

Primary Outcomes (1)

• Comparison of the efficacy of 2% chlorhexidine gluconate in 70% isopropyl alcohol and 10% sodium hypochlorite

  Compare decrease in colony forming units in cultures of samples taken with both antiseptics

  24 hours

Secondary Outcomes (7)

• Presence of skin reactions for the 2% chlorhexidine gluconate in 70% isopropyl alcohol

  24 hours

• Presence of allergy or any reaction at 24 hours after the antiseptic application.

  24 hours

• Bacterial count of skin cultures for the 2% chlorhexidine gluconate in 70% isopropyl alcohol

  24 hours

• Bacterial count of skin cultures for the 10% sodium hypochlorite

  24 hours

• Bacterial count of skin cultures for the control 1

  24 hours

Study Arms (2)

Whole group of 30 volunteers

EXPERIMENTAL

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; Other: Preparing skin's areas to be tested

test group of substantivity

EXPERIMENTAL

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

Interventions

Bacterial culture of the prepared skin's areas BIOLOGICAL

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.

Also known as: Neutralizing agar, Neutralizing broth

Whole group of 30 volunteers

Preparing skin's areas to be tested OTHER

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.

Also known as: Chloraprep (R), Except (R)

Whole group of 30 volunteers

Antiseptic substantivity BIOLOGICAL

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

Also known as: 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).

test group of substantivity

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult volunteers

You may not qualify if:

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

Sponsors & Collaborators

• Universidad de Guanajuato: lead
• Antisepsia Central: collaborator

Study Sites (1)

University of Guanajuato School of Medicine

León, Guanajuato, 37000, Mexico

Location

MeSH Terms

Conditions

Communicable Diseases

Interventions

chlorhexidine gluconate; 2-Propanol; Hypochlorous Acid; Povidone-Iodine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Chlorine Compounds; Reactive Oxygen Species; Free Radicals; Oxides; Oxygen Compounds; Iodophors; Iodine Compounds; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Alejandro E Macias, M. D.

  Universidad de Guanajuato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 23, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: June 24, 2013

Record last verified: 2011-09

Locations

ME (1)