Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics
|ClinicalTrials.gov Identifier: NCT00738543|
Recruitment Status : Completed
First Posted : August 20, 2008
Results First Posted : August 17, 2010
Last Update Posted : June 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Other: WHOLE GROUP OF 48 VOLUNTEERS||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparative Study of 10% Povidone-iodine Against 10% Sodium Hypochlorite as Skin Antiseptics in Human Volunteers.|
|Study Start Date :||August 2008|
|Primary Completion Date :||December 2008|
|Study Completion Date :||December 2008|
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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738543
|University of Guanajuato School of Medicine|
|Leon, Guanajuato, Mexico, 37000|
|Principal Investigator:||Alejandro E Macias, M. D.||Universidad de Guanajuato|