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Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics

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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
Enrollment 48
Recruitment Details Healthy volunteers recruited from August to December 2008 in the Microbiology Laboratory of University of Guanajuato, Mexico.
Pre-assignment Details 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.
Arm/Group Title Whole Group
Hide Arm/Group Description Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
Period Title: Povidone Iodine
Started 48
Completed 48
Not Completed 0
Period Title: Sodium Hypochlorite
Started 48
Completed 48
Not Completed 0
Period Title: Control
Started 48
Completed 48
Not Completed 0
Arm/Group Title Whole Group
Hide Arm/Group Description Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
<=18 years
0
   0.0%
Between 18 and 65 years
48
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants
24.4  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
24
  50.0%
Male
24
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mexico Number Analyzed 48 participants
48
1.Primary Outcome
Title Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period
Hide Description Bacterial colony count of skin cultures to determine antiseptic properties
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Group
Hide Arm/Group Description:
Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
Overall Number of Participants Analyzed 48
Median (Inter-Quartile Range)
Unit of Measure: Colony-forming units per cm squared
231
(77 to 615)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Whole Group
Comments The null hypothesis established that the three medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A minimal sample of 20 volunteers was calculated to to find a difference of 200 CFU/mL, with a power of 80% and bilateral error of 5%.
Statistical Test of Hypothesis P-Value <0.05
Comments Post-hoc test of Kruskal-Wallis for multiple comparisons of Z values was used to determine which arm was different.
Method Kruskal-Wallis
Comments 2 degrees of freedom corrected for ties
2.Primary Outcome
Title Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period
Hide Description After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Group
Hide Arm/Group Description:
Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
Overall Number of Participants Analyzed 48
Median (Inter-Quartile Range)
Unit of Measure: Colony-forming units per cm squared
192
(77 to 519)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Whole Group
Comments The null hypothesis established that the 3 medians were equal. To test significant differences for non-normally distributed data, a range test (Kruskal-Wallis) was used. The alpha level for significance was established at 5%. A minimal sample of 20 volunteers was calculated for a power of 80%, and bilateral error of 5%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The minimal sample of 20 volunteers was calculated to find a difference of 200 CFU/mL.
Statistical Test of Hypothesis P-Value <0.05
Comments Post-hoc test of Kruskal-Wallis for multiple comparisons of Z values was used to determine which arm was different.
Method Kruskal-Wallis
Comments 2 degrees of freedom corrected for ties
3.Primary Outcome
Title Bacterial Colony Forming Units for the Control Period
Hide Description After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Group
Hide Arm/Group Description:
Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
Overall Number of Participants Analyzed 48
Median (Inter-Quartile Range)
Unit of Measure: Colony-forming units per cm squared
1500
(635 to 3269)
4.Secondary Outcome
Title Presence of Skin Reactions for the 10% Povidone-iodine Period
Hide Description Presence of allergy or any skin reaction at 24 hours after the antiseptic application
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
A minimal sample of 20 volunteers was calculated to find a difference of 200 CFU/mL, with a power of 80%, and bilateral error of 5%. Analysis per protocol.
Arm/Group Title Whole Group
Hide Arm/Group Description:
Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Number of participants with skin reactio
0
5.Secondary Outcome
Title Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period
Hide Description Presence of allergy or skin reaction at 24 hours after the application of the antiseptic
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Whole Group
Hide Arm/Group Description:
Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: Number of participants with reaction
0
Time Frame 24 hours following the application of the antiseptics or control
Adverse Event Reporting Description All the participants were at risk for non-serious adverse events, "0" means that none suffered any adverse event.
 
Arm/Group Title Whole Group
Hide Arm/Group Description Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
All-Cause Mortality
Whole Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Whole Group
Affected / at Risk (%)
Total   0/48 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Whole Group
Affected / at Risk (%)
Total   0/48 (0.00%) 
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
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