In Vivo Preoperative Skin Preparation Persistence Evaluation

Persistent antimicrobial effectiveness was evaluated by measuring the regrowth of normal skin flora at 48 hours, 72 hours and 96 hours, and the suppression of regrowth relative to post-prep (10-min) at 48 hours, 72 hours and 96 hours.

• 3M CHG/IPA Prep (Drug), also known as Chlorhexidine Gluconate and Isopropyl Alcohol, CHG/IPA: Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.
• ChloraPrep (Drug), also known as Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine 2% / Isopropyl alcohol 70%, CHG/IPA, ChloraPrep One-Step: Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.

Primary outcomes

• Measurement of Skin Flora Recovery Post-prep Application [Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment]: 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.

Secondary outcomes

• Change in Skin Flora Relative to 10 Minutes Post-prep Application [10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment]: Log10 CFU/cm\^2 regrowth of skin flora, relative to 10-minute post-treatment log10 CFU/cm\^2, at 3 defined post-treatment sampling times.

Other outcomes

• Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment [Assessed at baseline (pre-treatment) and 10 minutes post-treatment, 48 hours post-treatment, 72 hours post-treatment, 96 hours post-treatment]: Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0=no reaction, 1=mild, 2=moderate, 3=severe.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

Participant flow

Outcome results

• Measurement of Skin Flora Recovery Post-prep Application (Primary), Mean, log10 CFU/cm^2: Experimental Prep - Abdominal Site 1.39 +/- 1.27; Active Comparator Prep - Abdominal Site 1.15 +/- 1.02; Experimental Prep - Inguinal Site 1.97 +/- 1.19; Active Comparator Prep - Inguinal Site 1.82 +/- 1.10 (p 0.13)
• Change in Skin Flora Relative to 10 Minutes Post-prep Application (Secondary), Mean, log10 CFU/cm^2: Experimental Prep - Abdominal Site -0.07 +/- 1.34; Active Comparator Prep - Abdominal Site -0.26 +/- 1.37; Experimental Prep - Inguinal Site 0.24 +/- 1.42; Active Comparator Prep - Inguinal Site 0.44 +/- 1.56 (p 0.38)
• Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment (Other pre specified), Number, sites: 3M CHG/IPA Prep Abdominal Region 62; ChloraPrep CHG/IPA Abdominal Region 62; 3M CHG/IPA Prep Inguinal Region 62; ChloraPrep CHG/IPA Inguinal Region 62

Adverse events

Time frame: Adverse events were collected during the treatment phase of the study. Product remained on each subject's skin for approximately 96 hours.

• Study Protocol and Statistical Analysis Plan (PDF, 2016-11-04)

• Rozalia Olsavszky, MD, Principal investigator, Evic / Eurofins