ClinicalTrials.gov
ClinicalTrials.gov Menu

Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics

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.
ClinicalTrials.gov Identifier: NCT00738543
Recruitment Status : Completed
First Posted : August 20, 2008
Results First Posted : August 17, 2010
Last Update Posted : June 24, 2013
Sponsor:
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Healthy Volunteers
Intervention: Other: WHOLE GROUP OF 48 VOLUNTEERS

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Healthy volunteers recruited from August to December 2008 in the Microbiology Laboratory of University of Guanajuato, Mexico.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
For stabilization of skin microbiota, all volunteers used neutral soap and shampoo without antiseptics over a period of two weeks, being advised to avoid swimming in pools.

Reporting Groups
  Description
Whole Group Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics

Participant Flow for 3 periods

Period 1:   Povidone Iodine
    Whole Group
STARTED   48 
COMPLETED   48 
NOT COMPLETED   0 

Period 2:   Sodium Hypochlorite
    Whole Group
STARTED   48 
COMPLETED   48 
NOT COMPLETED   0 

Period 3:   Control
    Whole Group
STARTED   48 
COMPLETED   48 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Whole Group Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics

Baseline Measures
   Whole Group 
Overall Participants Analyzed 
[Units: Participants]
 48 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   48 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 24.4  (9.3) 
Gender 
[Units: Participants]
 
Female   24 
Male   24 
Region of Enrollment 
[Units: Participants]
 
Mexico   48 


  Outcome Measures

1.  Primary:   Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period   [ Time Frame: 24 hours ]

2.  Primary:   Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period   [ Time Frame: 24 hours ]

3.  Primary:   Bacterial Colony Forming Units for the Control Period   [ Time Frame: 24 hours ]

4.  Secondary:   Presence of Skin Reactions for the 10% Povidone-iodine Period   [ Time Frame: 24 hours ]

5.  Secondary:   Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alejandro Macias
Organization: University of Guanajuato
phone: 52 477 7145859 ext 400
e-mail: aaeemmhh@yahoo.com



Responsible Party: Alejandro E. Macias, 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