A Phase 3 interventional study of Bacterial culture of the prepared skin's areas and Preparing skin's areas to be tested in Infectious Diseases, sponsored by Universidad de Guanajuato. Completed at 1 site in Mexico. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-24.
Sponsored by Universidad de Guanajuato · Phase 3, Interventional, and Prevention
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.
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.
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Exclusion Criteria:
The arm is composed of 30 human volunteers to test 2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep ®, Enturia, Texas, USA ), hypochlorite 10% of electrochemical production (Except 10% ®, Pisa, Guadalajara, Mexico), and two controls.
Biological: Bacterial culture of the prepared skin's areas · Other: Preparing skin's areas to be tested
The arm is composed of 10 human volunteers to test 2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep ®, Enturia, Texas, USA ), hypochlorite 10% of electrochemical production (Except 10% ®, Pisa, Guadalajara, Mexico), and 10% povidone-iodine (Isodine Solucion ®, Boehringer-Ingelheim Promeco, Mexico City)
Biological: Antiseptic substantivity
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.
Also known as: Neutralizing agar, Neutralizing broth
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.
Also known as: Chloraprep (R), Except (R)
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
Also known as: 2% chlorhexidine gluconate in 70% isopropyl alcohol (ChloraPrep ®, Enturia, Texas, USA ), hypochlorite 10% of electrochemical production (Except 10% ®, Pisa, Guadalajara, Mexico), 10% povidone-iodine (Isodine Solucion ®, Boehringer-Ingelheim Promeco, Mexico City), Muller Hinton agar plate (BD/BBL ™, México City, México).
Comparison of the efficacy of 2% chlorhexidine gluconate in 70% isopropyl alcohol and 10% sodium hypochlorite
Compare decrease in colony forming units in cultures of samples taken with both antiseptics
Time frame: 24 hours
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.
Time frame: 24 hours
Presence of allergy or any reaction at 24 hours after the antiseptic application.
Presence of allergy or any reaction at 24 hours after the antiseptic application.
Time frame: 24 hours
Bacterial count of skin cultures for the 2% chlorhexidine gluconate in 70% isopropyl alcohol
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.
Time frame: 24 hours
Bacterial count of skin cultures for the 10% sodium hypochlorite
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.
Time frame: 24 hours
Bacterial count of skin cultures for the control 1
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.
Time frame: 24 hours
Bacterial count of skin cultures for the control 2
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.
Time frame: 24 hours
Evaluation of antiseptic substantivity
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.
Time frame: 24 hours
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Universidad de Guanajuato