Clinical trial NCT01321125: Chlorhexidine Against Sodium Hypochlorite as Skin Antiseptics
Official title: Comparative Study of 2% Chlorhexidine Gluconate in 70% Isopropyl Alcohol Against 10% Sodium Hypochlorite as Skin Antiseptics in Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infectious Diseases
Keywords: Antiseptics
Administration cutaneously
Chlorine compounds
Anti-infecting agents, local
Lead sponsor: Universidad de Guanajuato
Sponsor class: OTHER
Collaborators: name: Antisepsia Central
First posted: 2011-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers

Exclusion Criteria:

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

Primary outcomes:
measure: Comparison of the efficacy of 2% chlorhexidine gluconate in 70% isopropyl alcohol and 10% sodium hypochlorite
timeFrame: 24 hours
Secondary outcomes:
measure: Presence of skin reactions for the 2% chlorhexidine gluconate in 70% isopropyl alcohol
timeFrame: 24 hours
measure: Presence of allergy or any reaction at 24 hours after the antiseptic application.
timeFrame: 24 hours
measure: Bacterial count of skin cultures for the 2% chlorhexidine gluconate in 70% isopropyl alcohol
timeFrame: 24 hours
measure: Bacterial count of skin cultures for the 10% sodium hypochlorite
timeFrame: 24 hours
measure: Bacterial count of skin cultures for the control 1
timeFrame: 24 hours
measure: Bacterial count of skin cultures for the control 2
timeFrame: 24 hours
measure: Evaluation of antiseptic substantivity
timeFrame: 24 hours
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: University of Guanajuato School of Medicine
state: Guanajuato
Study officials:
affiliation: Universidad de Guanajuato
name: Alejandro E Macias, M. D.
role: PRINCIPAL_INVESTIGATOR
References: