Infectious Diseases
Conditions
Keywords
Antiseptics, Administration cutaneously, Chlorine compounds, Anti-infecting agents, local
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.
Interventions
BIOLOGICALBacterial culture of the prepared skin's areas
Cultures were taken with a scrub-cup of 5cm2 of internal area pressed over the skin previously prepared, then it was added a 3mL of culture broth (C/E neutralizing broth (D/E Neutralizing Broth, DIFCO TM) containing a neutralizing agent and a detergent agent (1% solution tween-80) as washing solution. The skin was scrub with a sterile rubber policeman for 2 minutes, and the procedure was conducted once again. Both aliquots were gathered together in a sterile tube, and a sample of 50mL was spread in a plate containing a neutralizing agar (D/E neutralizing Agar, DIFCO TM) and incubated at 35°C for 72 hrs. After incubation, the colonies were counted.
OTHERPreparing skin's areas to be tested
Two antiseptics (2% chlorhexidine gluconate in 70% isopropyl alcohol and 10% sodium hypochlorite) and two controls were tested as skin antiseptics. The intervention consisted of preparing four skin's areas with the antiseptic or the control, two in each arm of the volunteer. These ones were approximately 25cm2 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 kept on the skin for 60 seconds before the bacterial culture was conducted. Every volunteer were studied in three separate occasions, alternating the four areas in every subsequent test, so every area was studied with each control or antiseptic.
BIOLOGICALAntiseptic substantivity
Three antiseptics will be tested: 2% chlorhexidine gluconate in 70% isopropyl alcohol, 10% sodium hypochlorite and 10% povidone-iodine, each one will be applied on the surface of one fingertip each, and will be allow to dry for 60 seconds, then the remaining antiseptic on the skin will be wash out with distilled water. The evaluated zones will be dried with sterile gauze, and then will be covered with sterile gauze for two hours. After this period, each finger will be placed for 30 seconds on an agar plate, which will be inoculated whit an ATCC E. coli. The plate will be incubated at 35ºC for 72 hrs. After incubation, a blinded technician will report the presence or absence of bacterial growth
Sponsors
Antisepsia Central
Universidad de Guanajuato
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult volunteers
Exclusion criteria
* History of skin allergies or atopy, as well as reactions to soaps, chlorine or latex
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the efficacy of 2% chlorhexidine gluconate in 70% isopropyl alcohol and 10% sodium hypochlorite | 24 hours | Compare decrease in colony forming units in cultures of samples taken with both antiseptics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of allergy or any reaction at 24 hours after the antiseptic application. | 24 hours | 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 | 24 hours | Bacterial colony count of skin cultures to determine antiseptic properties. After incubation, a blinded technician will count the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin. |
| Bacterial count of skin cultures for the 10% sodium hypochlorite | 24 hours | Bacterial colony count of skin cultures to determine antiseptic properties. After incubation, a blinded technician will count the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin. |
| Presence of skin reactions for the 2% chlorhexidine gluconate in 70% isopropyl alcohol | 24 hours | Presence of allergy or any reaction at 24 hours after the antiseptic application. |
| Bacterial count of skin cultures for the control 2 | 24 hours | Sample taken without wash. Bacterial colony count of skin cultures to determine antiseptic properties. After incubation, a blinded technician will count the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin. |
| Evaluation of antiseptic substantivity | 24 hours | Explore the extended antiseptic activity provide by 2% chlorhexidine gluconate in 70% isopropyl alcohol, 10% sodium hypochlorite and 10% povidone-iodine, by evaluating bacterial grow inhibition in an agar plate. |
| Bacterial count of skin cultures for the control 1 | 24 hours | Scrub with saline solution. Bacterial colony count of skin cultures to determine antiseptic properties. After incubation, a blinded technician will count the colonies to determine the colony-forming units per square centimeter (CFU/cm2) of skin. |
Countries
Mexico
Outcome results
None listed