Phase 3
N=1,594
In-vivo Efficacy Study of Patient Pre-operative Preps
Bacterial Reduction on Skin Flora Post-product Application
Bottom Line
View on ClinicalTrials.gov: NCT01968707 ↗Enrolled (actual)
1,594
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Responder Rate — 178; 167; 175; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ChloraPrep Hi-Lite Orange (Drug); Normal saline (Drug); 3M CHG/IPA Prep Tint 10.5-mL (Drug); 3M CHG/IPA Prep Tint 26-mL (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Solventum US LLC
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate |
178; 167; 175; 0; 168; 168 | — |
| SECONDARY Reduction of Skin Flora 6 Hours Post-treatment |
1.77; 0.47; 1.48; 1.64; 2.64; 1.08 | — |
| SECONDARY Reduction of Skin Flora 10 Minutes Post-treatment |
2.79; 0.64; 2.66; 2.74; 4.04; 1.34 | — |
| SECONDARY Skin Flora Recovery 6-hours Post-treatment |
1.54; 2.80; 1.87; 1.66; 2.81; 4.31 | — |
| SECONDARY Skin Flora Recovery 10 Minutes Post-treatment |
0.52; 2.63; 0.69; 0.57; 1.41; 4.06 | — |
| SECONDARY Skin Flora Baseline for the Abdominal and Inguinal Region. |
3.31; 3.27; 3.35; 3.31; 5.44; 5.40 | — |
| SECONDARY Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score |
247; 74; 246; 245; 236; 70 | — |
Summary
The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.
Eligibility Criteria
Inclusion Criteria
- Subjects of any race
- Subjects in good general 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 areas
- 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 (NCT01968707). 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.