Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics

Healthy Volunteers Clinical Trial

Official title:

Comparative Study of 10% Povidone-iodine Against 10% Sodium Hypochlorite as Skin Antiseptics in Human Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738543
• Other study ID #: FMUGAmuch
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2008
• Last updated: June 18, 2013
• Start date: August 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: Universidad de Guanajuato
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy adult volunteers.

Exclusion Criteria:

• History of skin allergies or atopy, as well as reactions to soaps, iodine, chlorine, or latex

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
Mexico	University of Guanajuato School of Medicine	Leon	Guanajuato

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Guanajuato	Concejo de Ciencia y Tecnología del Estado de Guanajuato, Pisa SA de CV

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period	Bacterial colony count of skin cultures to determine antiseptic properties	24 hours	No
Primary	Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period	After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.	24 hours	No
Primary	Bacterial Colony Forming Units for the Control Period	After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.	24 hours	No
Secondary	Presence of Skin Reactions for the 10% Povidone-iodine Period	Presence of allergy or any skin reaction at 24 hours after the antiseptic application	24 hours	Yes
Secondary	Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period	Presence of allergy or skin reaction at 24 hours after the application of the antiseptic	24 hours	Yes