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Completed

NCT Number: NCT00738543

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Guanajuato School of Medicine

León, Guanajuato, 37000, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult volunteers.

Exclusion criteria

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

Treatment and study plan

WHOLE GROUP OF 48 VOLUNTEERS

Other

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)

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Universidad de Guanajuato

Other

Collaborators

  • Concejo de Ciencia y Tecnología del Estado de Guanajuato
  • Pisa SA de CV

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 20, 2008
Registry last updated
Jun 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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