Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics

Phase 3

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: WHOLE GROUP OF 48 VOLUNTEERS

• Registration Number: NCT00738543
• Lead Sponsor: Universidad de Guanajuato

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-02
• Results First Submitted: 2009-07-17
• Results First Submitted QC: 2010-07-21
• Results First Posted: 2010-08-17
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Healthy adult volunteers.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Whole group of 48 volunteers	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.

Primary Outcome Measures

Name	Time	Method
Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period	24 hours	Bacterial colony count of skin cultures to determine antiseptic properties
Bacterial Colony Forming Units for the 10% Sodium Hypochlorite Period	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	24 hours	After incubation, the outcome assessor counted the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin.

Secondary Outcome Measures

Name	Time	Method
Presence of Skin Reactions for the 10% Povidone-iodine Period	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	24 hours	Presence of allergy or skin reaction at 24 hours after the application of the antiseptic

Trial Locations

Locations (1)

University of Guanajuato School of Medicine; 🇲🇽 Leon, Guanajuato, Mexico