NCT00738543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at below P25 for phase_3 healthy-volunteers

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_3 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

August 17, 2010

Completed
Last Updated

June 24, 2013

Status Verified

February 1, 2009

Enrollment Period

4 months

First QC Date

August 18, 2008

Results QC Date

July 17, 2009

Last Update Submit

June 18, 2013

Conditions

Healthy Volunteers

Keywords

AntisepticsAdministration, cutaneousIodophorsChlorine compoundsAnti-infecting agents, local

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Presence of Skin Reactions for the 10% Povidone-iodine Period

    24 hours

  • Presence af Allergy or Skin Reaction for the 10% Sodium Hypochlorite Period

    24 hours

Study Arms (1)

Whole group of 48 volunteers

EXPERIMENTAL

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

Interventions

WHOLE GROUP OF 48 VOLUNTEERSOTHER

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.

Also known as: Isodine (R), Exsept (R)
Whole group of 48 volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult volunteers.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Guanajuato School of Medicine

León, Guanajuato, 37000, Mexico

Location

MeSH Terms

Interventions

Povidone-Iodine

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Alejandro Macias
Organization
University of Guanajuato
aaeemmhh@yahoo.com
52 477 7145859

Study Officials

  • Alejandro E Macias, M. D.

    Universidad de Guanajuato

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor de tiempo completo

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 20, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

June 24, 2013

Results First Posted

August 17, 2010

Record last verified: 2009-02

Locations

ME(1)