Iodopovidone Against Amuchina as Skin Antiseptics - Full Text View

Purpose

The investigators have few options for skin antisepsis. Alternatives for Iodopovidone, 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% Amuchina or 10% Iodopovidone for skin antisepsis.

Condition	Intervention	Phase
Anti-Infecting Agents, Local	Other: Iodopovidone against Amuchina	Phase III

ChemIDplus related topics:

Povidone-iodine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Single Blind (Outcomes Assessor), Factorial Assignment, Efficacy Study

Official Title:	Comparative Study of 10% Iodopovidone Against 10% Amuchina as Skin Antiseptics in Human Volunteers.

Further study details as provided by Universidad de Guanajuato:

Primary Outcome Measures:

Bacterial count of skin cultures [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Presence of allergy o other skin reactions [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Human volunteers to test Iodopovidone, Amuchina, and control	Other: Iodopovidone against Amuchina 10% Iodopovidone against 10% amuchina for skin antisepsis

Detailed Description:

Amuchina 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 iodopovidone, which is the agent most commonly used, are costly or ineffective. To have more options, this study is needed to know if 10% amuchina is similar to the most common option for skin antisepsis.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adult volunteers.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738543

Locations


Mexico, Guanajuato
	University of Guanajuato School of Medicine	Recruiting
	Leon, Guanajuato, Mexico, 37000
	Contact: Alejandro E Macias, M. D. 524777145859 aaeemmhh@yahoo.com
	Contact: Juan M Munoz, M. D. 524777145859 jmunozb@lycos.com
	Principal Investigator: Alejandro E Macias, M. D.
	Sub-Investigator: Edmundo Rodriguez, M. D.
	Sub-Investigator: Juan H Macias
	Sub-Investigator: Jose A Alvarez, M. D.
	Sub-Investigator: Juan M Munoz, M. D.
	Sub-Investigator: Samuel Ponce de Leon, M. D.
	Sub-Investigator: Juan L Mosqueda, M. D.

Sponsors and Collaborators

Universidad de Guanajuato

Investigators


Principal Investigator:	Alejandro E Macias, M. D.	University of Guanajuato

Principal Investigator:	Alejandro E. Macias, M. D.	University of Guanajuato

More Information

Publications:

Humar A, Ostromecki A, Direnfeld J, Marshall JC, Lazar N, Houston PC, Boiteau P, Conly JM. Prospective randomized trial of 10% povidone-iodine versus 0.5% tincture of chlorhexidine as cutaneous antisepsis for prevention of central venous catheter infection. Clin Infect Dis. 2000 Oct;31(4):1001-7. Epub 2000 Oct 25.

Mendoza-Guevara L, Castro-Vazquez F, Aguilar-Kitsu A, Morales-Nava A, Rodriguez-Leyva F, Sanchez-Barbosa JL. Amuchina 10% Solution, Safe Antiseptic for Preventing Infections of Exit-Site of Tenckhoff Catheters, in the Pediatric Population of a Dialysis Program. Contrib Nephrol. 2007;154:139-144.

Responsible Party:	University of Guanajuato ( Alejandro E. Macias )
Study ID Numbers:	FMUGAmuch
First Received:	August 18, 2008
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00738543
Health Authority:	Mexico: Ministry of Health

Keywords provided by Universidad de Guanajuato:

Antiseptics

Administration, cutaneous

Iodophores

Chlorine compounds

Study placed in the following topic categories:

Povidone-Iodine

ClinicalTrials.gov processed this record on October 15, 2008

Sponsored by:	Universidad de Guanajuato
Information provided by:	Universidad de Guanajuato
ClinicalTrials.gov Identifier:	NCT00738543