In Vivo Patient Preoperative Skin Prep Persistence

Solventum US LLC27 enrolled

Overview

The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

The objective of the study is to demonstrate persistence of the CHG/IPA Prep versus a saline placebo on skin flora of the abdominal and inguinal regions of human subjects as measured by change in microbial flora relative to baseline.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Bacterial Recovery of Skin Flora Post-Product Application

Interventions

3M CHG/IPA Surgical Skin Preparation - Abdominal RegionDRUG

Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

Normal Saline - Abdominal RegionOTHER

0.9% sodium chloride applied with foam applicator

3M CHG/IPA Surgical Skin Preparation - Inguinal RegionDRUG

Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects of any race * Subjects in good general 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 areas * 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

Locations (1)

MicroBioTest

Sterling, Virginia, United States

Outcomes

Primary Outcomes

Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline

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.

Time frame: Baseline, 48 hours and 72 hours post-prep application

Secondary Outcomes

Safety as Assessed by Skin Irritation Scores Coded by Study Staff

For the conditions of erythema, edema, rash, and dryness, a rating of 0 (no reaction), 1 (mild and/or transient, limited to sensitive area), 2 (moderate, persisting over much of the product-exposed area), or 3 (severe, extending over most or all of the product-exposed area) was recorded on the Skin Irritation Rating form of the eCRF.

Time frame: 48 hours and 72 hours post-product application

Safety as Assessed by Adverse Events

Number of subjects with adverse events as self-reported or identified by study staff

Time frame: To 72 hours post treatment

Data from ClinicalTrials.gov

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