Chlorhexidine Against Sodium Hypochlorite as Skin Antiseptics

Condition(s) targeted: Infectious Diseases

Intervention: Bacterial culture of the prepared skin's areas (Biological); Preparing skin's areas to be tested (Other); Antiseptic substantivity (Biological)

Phase: Phase 3

Status: Recruiting

Sponsored by: Universidad de Guanajuato

Official(s) and/or principal investigator(s):
Alejandro E Macias, M. D., Principal Investigator, Affiliation: University of Guanajuato

Overall contact:
Alejandro E. Macias, M. D., Phone: 524777145859, Email: aaeemmhh@yahoo.com

The physicians have few options for skin antisepsis. Alternatives for common use antiseptics are costly or ineffective. In order to have more options, this study is needed. The investigators want to know if there are differences between the use of 2% chlorhexidine gluconate in 70% isopropyl alcohol or 10% sodium hypochlorite.

Official title: Comparative Study of 2% Chlorhexidine Gluconate in 70% Isopropyl Alcohol Against 10% Sodium Hypochlorite as Skin Antiseptics in Human Volunteers

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Comparison of the efficacy of 2% chlorhexidine gluconate in 70% isopropyl alcohol and 10% sodium hypochlorite

Secondary outcome:

Presence of skin reactions for the 2% chlorhexidine gluconate in 70% isopropyl alcohol

Presence of allergy or any reaction at 24 hours after the antiseptic application.

Bacterial count of skin cultures for the 2% chlorhexidine gluconate in 70% isopropyl alcohol

Bacterial count of skin cultures for the 10% sodium hypochlorite

Bacterial count of skin cultures for the control 1

Bacterial count of skin cultures for the control 2

Evaluation of antiseptic substantivity

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 side 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. In a recent study perform by our group it was demonstrated that 10% sodium hypochlorite was not inferior than povidone-iodine.

It has been demonstrated as well that 2% chlorhexidine gluconate in 70% isopropyl alcohol is superior to povidone-iodine. The aim of this study is to know if 10% sodium hypochlorite has a similar effect that the best current option for skin antisepsis.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy adult volunteers

Exclusion Criteria:

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

Alejandro E. Macias, M. D., Phone: 524777145859, Email: aaeemmhh@yahoo.com

University of Guanajuato School of Medicine, Leon, Guanajuato 37000, Mexico; Recruiting
Juan M Munoz, M. D., Phone: 524777145859, Email: jmunozb@lycos.com
Alejandro E. Macias, M. D., Principal Investigator
Juan H Macias, M. D., 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., Sub-Investigator

Starting date: April 2011
Last updated: November 26, 2011