Phase 3
N=308
Efficacy Study of Patient Preoperative Preps In-vivo
Surgical Skin Preparation
Bottom Line
View on ClinicalTrials.gov: NCT04756154 ↗Enrolled (actual)
308
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes — 3.60; 3.61; 1.15 Log10 CFU/cm^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CHG/IPA Surgical skin preparation (Drug); Normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Solventum US LLC
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes |
3.60; 3.61; 1.15 | — |
| PRIMARY Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours |
1.98; 2.40; 1.03 | — |
Summary
The purpose of this study is to determine the antimicrobial efficacy of an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects.
Eligibility Criteria
Inclusion Criteria
- Subjects of any race
- Subjects in good health
- Minimum skin flora baseline requirements on inguinal region
Exclusion Criteria
- Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area
- Topical antimicrobial exposure within 14 days prior to screening and treatment days
- Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days
Data sourced from ClinicalTrials.gov (NCT04756154). 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.