Clinical trial NCT02203591: In Vivo Efficacy Study of Patient Preoperative Preps
Official title: Assessment of the Antimicrobial Efficacy of 3M CHG/IPA Preoperative Skin Preparation Against Resident Human Skin Flora on the Abdominal and Inguinal Regions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Reduction Post-product Application
Keywords: surgical skin prep
CHG
IPA
Lead sponsor: 3M
Sponsor class: INDUSTRY
First posted: 2014-07-30
Enrollment: 738
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70% On the abdominal site, a responder is defined as a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

On the inguinal site, a responder is defined as a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

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

Primary outcomes:
measure: Responder Rate
timeFrame: baseline, 10 minutes post-product application and 6 hours post-product application
measure: Alternative Primary
timeFrame: Baseline and 10 minutes
Secondary outcomes:
measure: Reduction of Skin Flora 6 Hours Post-treatment
timeFrame: 6 hours
measure: Reduction of Skin Flora 10 Minutes Post-treatment
timeFrame: 10 minutes
measure: Skin Flora Recovery 6-hours Post-treatment
timeFrame: 6 hours post-treatment
measure: Skin Flora Recovery 10 Minutes Post-treatment
timeFrame: 10 minute post-product application
measure: Skin Flora Baseline for the Abdomen and Inguinal Region.
timeFrame: Baseline
measure: Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
timeFrame: Baseline
measure: Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
timeFrame: 10 minutes post-treatment
measure: Safety as Assessed by Skin Irritation Score
timeFrame: 6 hours post-treatment
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: BioScience Laboratories, Inc.
state: Montana
Study officials:
affiliation: Independent Consultant
name: Jamie Miller, ADN
role: PRINCIPAL_INVESTIGATOR
References: