Phase 3
N=1,946
In Vivo Efficacy Study of Patient Preoperative Preps
Bacterial Reduction Post-product Application
Bottom Line
View on ClinicalTrials.gov: NCT02203591 ↗Enrolled (actual)
1,946
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Responder Rate — 159; 165; 163; 5 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 3M CHG/IPA Prep C (Drug); 3M CHG/IPA Prep CH (Drug); ChloraPrep (Drug); Normal Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- 3M
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate |
159; 165; 163; 5; 81; 98 | <0.0001 sig |
| PRIMARY Alternative Primary |
2.84; 2.99; 3.17 | — |
| SECONDARY Reduction of Skin Flora 6 Hours Post-treatment |
2.83; 2.86; 2.83; 1.00; 3.46; 3.49 | — |
| SECONDARY Reduction of Skin Flora 10 Minutes Post-treatment |
2.78; 2.73; 2.75; 0.76; 2.84; 2.99 | — |
| SECONDARY Skin Flora Recovery 6-hours Post-treatment |
0.80; 0.74; 0.81; 2.65; 2.76; 2.73 | — |
| SECONDARY Skin Flora Recovery 10 Minutes Post-treatment |
0.85; 0.88; 0.90; 2.88; 3.39; 3.21 | — |
| SECONDARY Skin Flora Baseline for the Abdomen and Inguinal Region. |
3.63; 3.61; 3.64; 3.64; 6.23; 6.21 | — |
| SECONDARY Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score |
343; 344; 347; 104; 240; 244 | — |
| SECONDARY Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score |
343; 344; 347; 104; 242; 244 | — |
| SECONDARY Safety as Assessed by Skin Irritation Score |
334; 330; 336; 101; 240; 240 | — |
Summary
The objective of this study is to demonstrate 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 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 (NCT02203591). 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.