Approval Probability
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Adjusted LOA
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3M CHG/IPA Surgical Skin Preparation- Abdominal Region · 3 trials · 3 indications
The primary measure of efficacy is change in skin flora log10 CFU/cm\^2 in each of the skin sampling sites relative to baseline skin flora log10 CFU/cm\^2. Baseline samples must satisfy the greater than or equal to 3.0 in each of the sampling sites, to be used for data analysis.
The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm\^2) of skin flora at 3 defined post-treatment sampling times.
The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm\^2) of skin flora at two defined post-prep sampling times relative to baseline.
| Arm | Type | Description |
|---|---|---|
| 3M CHG/IPA Prep / Center | EXPERIMENTAL | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from center test site on skin in application area. |
| 3M CHG/IPA Prep / Mid-peripheral | EXPERIMENTAL | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from mid-peripheral test site on skin in application area. |
| 3M CHG/IPA Prep / Peripheral | EXPERIMENTAL | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from peripheral test site on skin in application area. |
| 3M CHG/IPA Prep | EXPERIMENTAL | Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes. |
| ChloraPrep | ACTIVE_COMPARATOR | Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes. |
| 3M CHG/IPA - Abdominal Region | EXPERIMENTAL | Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes. |
| Normal Saline - Abdominal Region | PLACEBO_COMPARATOR | Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes. |
| 3M CHG/IPA - Inguinal Region | EXPERIMENTAL | Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes. |
| Normal Saline - Inguinal Region | PLACEBO_COMPARATOR | Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes. |
| Name | Type | Description |
|---|---|---|
| 3M CHG/IPA Prep | DRUG | Apply topically to intact skin |
| ChloraPrep | DRUG | Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes. |
| 3M CHG/IPA Surgical Skin Preparation - Abdominal Region | DRUG | Chlorhexidine gluconate 2% / Isopropyl alcohol 70% |
| Normal Saline - Abdominal Region | OTHER | 0.9% sodium chloride applied with foam applicator |
| 3M CHG/IPA Surgical Skin Preparation - Inguinal Region | DRUG | Chlorhexidine gluconate 2% / Isopropyl alcohol 70% |
| Normal Saline - Inguinal Region | OTHER | 0.9% sodium chloride applied with foam applicator |
Inclusion Criteria: * Male subjects of any race who are at least 18 years of age, * Subjects must have an area on their back region to accommodate the treatment coverage area, * Subjects must be in good general health, * Subjects who satisfy all inclusion/exclusion criteria and will voluntarily rea...
3M CHG/IPA Surgical Skin Preparation - Abdominal Region is used for preoperative surgical skin preparation and for reducing bacterial recovery of skin flora after product application. It is applied to the abdominal region before surgical procedures to help lower the number of bacteria on the skin at the surgical site.
3M CHG/IPA Surgical Skin Preparation - Abdominal Region is developed by Solventum Corporation, which trades under the ticker SOLV. Solventum is the company responsible for the product's clinical development in surgical skin preparation.
3M CHG/IPA Surgical Skin Preparation - Abdominal Region is in Phase 2 clinical development. It is an investigational product and has completed two Phase 2 trials. No Phase 3 trials are listed for this product.
3M CHG/IPA Surgical Skin Preparation - Abdominal Region has been studied in completed Phase 2 trials including NCT03681990, which enrolled 28 males in Romania, and NCT03155178, which enrolled 69 participants. Both trials evaluated preoperative skin preparation efficacy or persistence.