Phase 3
N=335
Test for Pre Operative Skin Preparations
Topical Antisepsis
Bottom Line
View on ClinicalTrials.gov: NCT00799812 ↗Enrolled (actual)
335
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites — 3.51; 3.44; 3.15; 0.92 Average log10 reductions in CFU/cm2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once). (Drug); CHG 2% w/v & IPA 70% v/v swab applied sequentially (Drug); Aqueous CHG 4% w/v applied according to mfr's directions (Drug); Sterile swabstick with sterile water (3 @ once) (Other); Sterile swabstick with sterile water (one-at-a-time) (Other)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- C. R. Bard
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites |
3.51; 3.44; 3.15; 0.92; 0.97; 3.22 | — |
Summary
Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick.
Eligibility Criteria
Inclusion Criteria
- Subjects must read and sign an Informed Consent Form and be cooperative.
- Subjects must be in good general health.
- Subjects must have skin within 6 inches of the test site that is free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorders.
Exclusion Criteria
- Use of systemic or topical antimicrobials during the 2-week pretest conditioning period. This restriction includes but is not limited to shampoos, lotions, soaps, baby powders, and materials, such as solvents, acids, or alkalis.
- A medical diagnosis of a physical condition, which would preclude participation such as: diabetes, hepatitis, an organ transplant, a medical surgical implant, or an immunocompromised system.
- Any medical condition that in the opinion of the investigator would preclude participation.
- Bathed in chemically treated pools or hot tubs 2 weeks prior to any microbial sampling.
- Used UV tanning lamps 2 weeks prior to any microbial sampling.
- Bathing or showering less than 48 hours prior to any microbial sampling.
- Known sensitivity to chlorhexidine gluconate.
- Known sensitivity to latex (rubber).
- Known sensitivity to fragrances.
- Pregnant or nursing.
- Unwillingness to fulfill the performance requirements of the study.
- Subjects who have completed part or all of the study will not be reentered in the study.
Data sourced from ClinicalTrials.gov (NCT00799812). 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.