Phase 3
N=135
Residual Effect of Chlorhexidine-alcohol Compared to Triclosan-alcohol
Infectious Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01762904 ↗Enrolled (actual)
135
Serious AEs
—
Results posted
Jul 2014
Primary outcome: Primary: Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically — 24; 48; 24 (CFU/cm2) — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 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 (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universidad de Guanajuato
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate the Residual Effect of Chlorhexidine 2% / Isopropyl Alcohol 70% Administered Topically |
24; 48; 24 | <0.05 sig |
| PRIMARY Evaluate the Residual Effect of Triclosan 1% / Isopropyl Alcohol 70% Administered Topically. |
48; 48; 96 | <0.05 sig |
| PRIMARY Evaluate the Effect on the Skin Flora Application Process of Antiseptics by Sterile Swab |
480; 216; 288; 96; 288; 96 | <0.05 sig |
| SECONDARY Detect Presence of Allergy or Skin Reaction by the Antiseptic Application |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01762904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.