Phase 2
N=96
In Vivo Patient Preoperative Skin Prep Persistence
Bacterial Recovery of Skin Flora Post-Product Application
Bottom Line
View on ClinicalTrials.gov: NCT02447497 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline — 0.91; 2.81; 0.59; 2.96 Log10 CFU/cm^2 — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 3M CHG/IPA Surgical Skin Preparation - Abdominal Region (Drug); Normal Saline - Abdominal Region (Other); 3M CHG/IPA Surgical Skin Preparation - Inguinal Region (Drug); Normal Saline - Inguinal Region (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Solventum US LLC
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline |
0.91; 2.81; 0.59; 2.96; 0.93; 2.44 | <0.0001 sig |
| SECONDARY Safety as Assessed by Skin Irritation Scores Coded by Study Staff |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Safety as Assessed by Adverse Events |
0; 0; 0; 0 | — |
Summary
The objective of the study is to demonstrate persistence of the 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 (NCT02447497). 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.