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Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics

This study has been completed.
Sponsor:
Collaborators:
CONCYTEG
Pisa SA de CV
Information provided by:
Universidad de Guanajuato
ClinicalTrials.gov Identifier:
NCT00738543
First received: August 18, 2008
Last updated: May 23, 2011
Last verified: February 2009
History of Changes
  Purpose

The investigators have few options for skin antisepsis. Alternatives for povidone-iodine, which is the most commonly used agent, are costly or ineffective. To have more options, this study is needed. The investigators want to know if there are difference between the use of 10% sodium hypochlorite or 10% povidone-iodine for skin antisepsis.


Condition Intervention Phase
Healthy Volunteers
 Other: Testing antiseptics and control
 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 10% Povidone-iodine Against 10% Sodium Hypochlorite as Skin Antiseptics in Human Volunteers.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidad de Guanajuato:

Primary Outcome Measures:
  • Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Bacterial colony count of skin cultures to determine antiseptic properties

  • Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.

  • Bacterial Colony Forming Units for the Control Period [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.


Secondary Outcome Measures:
  • Presence of Skin Reactions for the 10% Povidone-iodine Period [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Presence of allergy or any skin reaction at 24 hours after the antiseptic application

  • Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Presence of allergy or skin reaction at 24 hours after the application of the antiseptic


Enrollment: 48
Study Start Date: August 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Whole group of 48 volunteers
The arm is composed of 48 human volunteers to test 10% povidone-iodine (Isodine Solucion ®, Boehringer-Ingelheim Promeco, Mexico City), Hypochlorite 10% of electrochemical production (Exsept 10% ®, Pisa, Guadalajara, Mexico), and control.
 Other: Testing antiseptics and control
Two antiseptics (10% povidone iodine and 10% sodium hypochlorite) and one control were tested as skin antiseptics. The intervention consisted of preparing the skin with the antiseptic or the control. The areas were approximately 25 cm2 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 then kept on the skin for 60 seconds before the bacterial culture was conducted. All volunteers were instructed to continue the use of neutral soap and shampoo without antiseptics during the follow-up period.
Other Names:
  • Isodine (R)
  • Exsept (R)

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 site 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. To have more options, this study is needed to know if 10% sodium hypochlorite is similar to the most common option for skin antisepsis.

  Eligibility

Ages Eligible for Study:   18 Years and older
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, iodine, chlorine, or latex
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738543

Locations
Mexico
University of Guanajuato School of Medicine
Leon, Guanajuato, Mexico, 37000
Sponsors and Collaborators
Universidad de Guanajuato
CONCYTEG
Pisa SA de CV
Investigators
Principal Investigator: Alejandro E Macias, M. D. University of Guanajuato
  More Information

No publications provided

Responsible Party: Alejandro E. Macias, University of Guanajuato
ClinicalTrials.gov Identifier: NCT00738543     History of Changes
Other Study ID Numbers: FMUGAmuch
Study First Received: August 18, 2008
Results First Received: July 17, 2009
Last Updated: May 23, 2011
Health Authority: Mexico: Ministry of Health

Keywords provided by Universidad de Guanajuato:
Antiseptics
Administration, cutaneous
Iodophors
Chlorine compounds
Anti-infecting agents, local

Additional relevant MeSH terms:
Anti-Infective Agents, Local
Iodine
Povidone-Iodine
Sodium Hypochlorite
Eusol
Povidone
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Disinfectants
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013