Surgical Skin Preparation Clinical Trial
Official title:
Assessment of the Antimicrobial Efficacy of 3M™ SoluPrep™ Preoperative Skin Preparation Against Resident Human Skin Flora on the Inguinal Region
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.
Non-inferiority of the investigational product to the FDA-approved active control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. Non-inferiority is based on a non-inferiority margin of 0.5 log10/cm2. Superiority of the active products to the negative control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. A superiority margin of 1.2 log10/cm2 is used. Number of observations for which the log10/cm2 recovery of skin flora on the inguinal region at 6 hours following application of the study products is higher than treatment day log10/cm2 baseline skin flora. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03681990 -
In Vivo Preoperative Skin Preparation Efficacy Study Within a Defined Product Coverage Area
|
Phase 2 | |
| Completed |
NCT02831998 -
In-vivo Efficacy of Patient Preoperative Prep
|
Phase 3 | |
| Completed |
NCT03331263 -
Single Dose CHG Pharmacokinetic Study
|
Phase 1 | |
| Completed |
NCT03782103 -
In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)
|
Phase 3 | |
| Completed |
NCT02831816 -
Clinical Evaluation of Patient Preoperative Prep
|
Phase 3 |