Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Comparative Study of 10% Povidone-iodine Against 10% Sodium Hypochlorite as Skin Antiseptics in Human Volunteers.|
- Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period [ Time Frame: 24 hours ] [ Designated as safety issue: No ]Bacterial colony count of skin cultures to determine antiseptic properties
- Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period [ Time Frame: 24 hours ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Presence of allergy or skin reaction at 24 hours after the application of the antiseptic
|Study Start Date:||August 2008|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738543
|University of Guanajuato School of Medicine|
|Leon, Guanajuato, Mexico, 37000|
|Principal Investigator:||Alejandro E Macias, M. D.||University of Guanajuato|