Povidone-iodine Against Sodium Hypochlorite as Skin Antiseptics

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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: WHOLE GROUP OF 48 VOLUNTEERS

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37000
      • University of Guanajuato School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adult volunteers.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.; Other Names: Isodine (R); Exsept (R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial Count of Skin Cultures for the 10% Povidone-iodine Period	Bacterial colony count of skin cultures to determine antiseptic properties	24 hours
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Universidad de Guanajuato
• Collaborators: Concejo de Ciencia y Tecnología del Estado de Guanajuato; Pisa SA de CV
• Investigators: Principal Investigator: Alejandro E Macias, M. D., Universidad de Guanajuato

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: August 18, 2008
• First Submitted That Met QC Criteria: August 19, 2008
• First Posted (Estimate): August 20, 2008

Study Record Updates

• Last Update Posted (Estimate): June 24, 2013
• Last Update Submitted That Met QC Criteria: June 18, 2013
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Antiseptics; Anti-infecting agents, local; Chlorine compounds; Administration, cutaneous; Iodophors
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Povidone-Iodine
• Other Study ID Numbers: FMUGAmuch