Phase 2
N=276
In Vivo Preoperative Skin Preparation Persistence Evaluation
Bacterial Recovery of Skin Flora Post-product Application
Bottom Line
View on ClinicalTrials.gov: NCT03155178 ↗Enrolled (actual)
276
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Measurement of Skin Flora Recovery Post-prep Application — 1.39; 1.15; 1.97; 1.82 log10 CFU/cm^2 — p=0.13
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 3M CHG/IPA Prep (Drug); ChloraPrep (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Solventum US LLC
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Skin Flora Recovery Post-prep Application |
1.39; 1.15; 1.97; 1.82; 0.89; 0.92 | 0.13 |
| SECONDARY Change in Skin Flora Relative to 10 Minutes Post-prep Application |
-0.07; -0.26; 0.24; 0.44; -0.57; -0.49 | 0.38 |
Summary
Evaluate persistent antimicrobial effectiveness of chlorhexidine gluconate containing products on abdominal and inguinal sites following a saline and wipe challenge.
Eligibility Criteria
Inclusion Criteria
- Subjects of any race
- Subjects in good health
- Minimum skin flora baseline requirements on abdomen and groin
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 (NCT03155178). 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.