Infectious Diseases
Conditions
Keywords
Antiseptics, Administration cutaneously, Anti-infecting agents, local
Brief summary
Currently there are few options for skin antisepsis, commercially antiseptic triclosan is mainly used. To have more options, this study is necessary, where investigators will determine the residual effect of 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and choose the one with the best characteristics for skin antisepsis.
Detailed description
2% chlorhexidine has been used as an antiseptic for invasive procedures, such as the skin preparation for surgery or insertion of intravascular catheters, thereby decreasing the incidence of infections. The preparation of the skin with antiseptics, helps mechanically clean the surface of the skin to be subjected to surgical intervention, removing fat, sweat, dead cells and kill bacteria that are in the skin. It has been shown that 2% chlorhexidine in solution with 70% isopropyl alcohol has greater activity than chlorhexidine in aqueous solution. The constant use of triclosan causes resistance of some microorganisms on some antibiotics.It has been shown that 0.5% of triclosan in 60% alcohol isopropyl chlorhexidine is more effective than alcohol. The aim of the study is to know if 2% chlorhexidine has more residual effect than triclosan 1%, both antiseptic diluted in 70% isopropyl alcohol.
Interventions
OTHERBacterial culture of the prepared skin's areas with two antiseptics and two controls
Cultures will be taken with a scrub-cup of 5 cm2 of internal area pressed over the skin previously prepared with the substances, then it added a 3 mL of culture broth (D/E Neutralizing Broth, Difco TM) containing a neutralizing agent as washing solution. The skin will scrub with a sterile rubber policeman for 1 minute and the procedure will be conducted once again. Both aliquots will gather together in a sterile tube, and a sample of 50 microliters will spread in a plate containing a neutralizing agar (D/E neutralizing Agar, Difco TM) and incubate at 35°C for 24 hrs. After incubation, the colonies will be counted.
OTHERPreparing skin's areas to be tested with two antiseptics and two controls
All volunteers will be provided with a neutral soap and shampoo without antiseptics for use during a period of two weeks (phase of stabilization of the skin flora). Two antiseptics (2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol) and two controls (Scrub the skin without prior application of any substance and Deionized water redistilled) will be tested as skin antiseptics. The intervention consists of preparing four skin's areas with antiseptics and controls, two in each arm of the volunteer. These ones were approximately 25 cm2 on the forearm for each antiseptic or control. The substances will be applied in an outward circular motion using a sterile swab soaked with the solutions. The solution will remain on the skin for 60 seconds, 3 hours and 24 hours before the bacterial culture will be conducted. For the control where it will be does not apply any substance, the scrub starts immediately.
Sponsors
Antisepsia Central
Universidad de Guanajuato
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult volunteers * Volunteers who have completed the stabilization phase of skin flora. * Volunteers who does not taken a shower or bath 24 hours before the test.
Exclusion criteria
* Volunteers with a score below 100 Colony Forming Unit per square centimeter (CFU/cm2) of forearm skin surface in the control after the stabilization of the skin flora. * History of skin allergies or atopy, as well as reactions to alcohol, soaps, iodine, chlorine or latex.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically | 24 hours | 135 determinations to evaluate residual effect of 2% chlorhexidine in 70% isopropyl alcohol. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days. Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h. |
| Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically. | 24 hours | 135 determinations to test 1% triclosan in 70% isopropyl alcohol. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 1% triclosan in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days. Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h. |
| Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab | 24 hrs | 135 units of measurement to test two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. Deionized water redistilled (Control 2: Control with scrub) and Scrub the skin without prior application of any substance (Control1: Control without scrub) was tested. Were prepared two skin's areas of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h. Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detect Presence of Allergy or Skin Reaction by the Antiseptic Application | 24 hours | 135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. We prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h. Presence of allergy or any skin reaction at 24 hours after the antiseptic application. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Whole Group of 135 Units of Measurement The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls.
The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination.
Interventions:
* Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls
* Other: Preparing skin's areas to be tested with two antiseptics and two controls | 119 |
| Total | 119 |
Baseline characteristics
| Characteristic | Whole Group of 135 Units of Measurement |
|---|---|
| Age, Continuous | 22 years |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab
135 units of measurement to test two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. Deionized water redistilled (Control 2: Control with scrub) and Scrub the skin without prior application of any substance (Control1: Control without scrub) was tested. Were prepared two skin's areas of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h. Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.
Time frame: 24 hrs
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Whole Group of 135 Units of Measurement | Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab | Control 1: without scrub 0 h | 480 (CFU/cm2) |
| Whole Group of 135 Units of Measurement | Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab | Control 2: scrub with Deionized water redisti 0 h | 216 (CFU/cm2) |
| Whole Group of 135 Units of Measurement | Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab | Control 1: without scrub 3 h | 288 (CFU/cm2) |
| Whole Group of 135 Units of Measurement | Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab | Control 2: scrub with Deionized water redisti 3 h | 96 (CFU/cm2) |
| Whole Group of 135 Units of Measurement | Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab | Control 1: without scrub 24 h | 288 (CFU/cm2) |
| Whole Group of 135 Units of Measurement | Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab | Control 2: scrub with Deionized water redisti 24 h | 96 (CFU/cm2) |
p-value: <0.05Kruskal-Wallis
Primary
Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically
135 determinations to evaluate residual effect of 2% chlorhexidine in 70% isopropyl alcohol. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days. Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.
Time frame: 24 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Whole Group of 135 Units of Measurement | Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically | 24 h | 24 (CFU/cm2) |
| Whole Group of 135 Units of Measurement | Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically | 0 h | 24 (CFU/cm2) |
| Whole Group of 135 Units of Measurement | Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically | 3 h | 48 (CFU/cm2) |
p-value: <0.05Kruskal-Wallis
Primary
Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically.
135 determinations to test 1% triclosan in 70% isopropyl alcohol. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 1% triclosan in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days. Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h.
Time frame: 24 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Whole Group of 135 Units of Measurement | Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically. | 0 h | 48 (CFU/cm2) |
| Whole Group of 135 Units of Measurement | Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically. | 3 h | 48 (CFU/cm2) |
| Whole Group of 135 Units of Measurement | Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically. | 24 h | 96 (CFU/cm2) |
p-value: <0.05Kruskal-Wallis
Secondary
Detect Presence of Allergy or Skin Reaction by the Antiseptic Application
135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites. All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. We prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h. Presence of allergy or any skin reaction at 24 hours after the antiseptic application.
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Whole Group of 135 Units of Measurement | Detect Presence of Allergy or Skin Reaction by the Antiseptic Application | 0 participants |