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Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00738543
First Posted: August 20, 2008
Last Update Posted: June 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Concejo de Ciencia y Tecnología del Estado de Guanajuato
Pisa SA de CV
Information provided by (Responsible Party):
Alejandro E. Macias, Universidad de Guanajuato
  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: WHOLE GROUP OF 48 VOLUNTEERS Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (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:


Further study details as provided by Alejandro E. Macias, Universidad de Guanajuato:

Primary Outcome Measures:
  • Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period [ Time Frame: 24 hours ]
    Bacterial colony count of skin cultures to determine antiseptic properties

  • Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period [ Time Frame: 24 hours ]
    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 ]
    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 ]
    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 ]
    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: WHOLE GROUP OF 48 VOLUNTEERS
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738543


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

Responsible Party: Alejandro E. Macias, Profesor de tiempo completo, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT00738543     History of Changes
Other Study ID Numbers: FMUGAmuch
First Submitted: August 18, 2008
First Posted: August 20, 2008
Results First Submitted: July 17, 2009
Results First Posted: August 17, 2010
Last Update Posted: June 24, 2013
Last Verified: February 2009

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

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