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Trial Outcomes & Findings for Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics (NCT NCT00738543)

NCT ID: NCT00738543

Last Updated: 2013-06-24

Results Overview

Bacterial colony count of skin cultures to determine antiseptic properties

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

48 participants

Primary outcome timeframe

24 hours

Results posted on

2013-06-24

Participant Flow

Healthy volunteers recruited from August to December 2008 in the Microbiology Laboratory of University of Guanajuato, Mexico.

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.

Participant milestones

Participant milestones
Measure
Whole Group
Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
Povidone Iodine
STARTED
48
Povidone Iodine
COMPLETED
48
Povidone Iodine
NOT COMPLETED
0
Sodium Hypochlorite
STARTED
48
Sodium Hypochlorite
COMPLETED
48
Sodium Hypochlorite
NOT COMPLETED
0
Control
STARTED
48
Control
COMPLETED
48
Control
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Whole Group
n=48 Participants
Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
48 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age Continuous
24.4 years
STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male
Female
24 Participants
n=5 Participants
Sex: Female, Male
Male
24 Participants
n=5 Participants
Region of Enrollment
Mexico
48 participants
n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Bacterial colony count of skin cultures to determine antiseptic properties

Outcome measures

Outcome measures
Measure
Whole Group
n=48 Participants
Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period
231 Colony-forming units per cm squared
Interval 77.0 to 615.0

PRIMARY outcome

Timeframe: 24 hours

After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.

Outcome measures

Outcome measures
Measure
Whole Group
n=48 Participants
Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period
192 Colony-forming units per cm squared
Interval 77.0 to 519.0

PRIMARY outcome

Timeframe: 24 hours

After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.

Outcome measures

Outcome measures
Measure
Whole Group
n=48 Participants
Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
Bacterial Colony Forming Units for the Control Period
1500 Colony-forming units per cm squared
Interval 635.0 to 3269.0

SECONDARY outcome

Timeframe: 24 hours

Population: 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.

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

Outcome measures

Outcome measures
Measure
Whole Group
n=48 Participants
Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
Presence of Skin Reactions for the 10% Povidone-iodine Period
0 Number of participants with skin reactio

SECONDARY outcome

Timeframe: 24 hours

Presence of allergy or skin reaction at 24 hours after the application of the antiseptic

Outcome measures

Outcome measures
Measure
Whole Group
n=48 Participants
Human volunteers to test control, povidone-iodine and hypochlorite as skin antiseptics
Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period
0 Number of participants with reaction

Adverse Events

Whole Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alejandro Macias

University of Guanajuato

Phone: 52 477 7145859

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place