In Vivo Preoperative Skin Preparation Persistence Evaluation

Solventum US LLC69 enrolled

Overview

Evaluate persistent antimicrobial effectiveness of chlorhexidine gluconate containing products on abdominal and inguinal sites following a saline and wipe challenge.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Bacterial Recovery of Skin Flora Post-product Application

Interventions

3M CHG/IPA PrepDRUG

Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.

ChloraPrepDRUG

Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Measurement of Skin Flora Recovery Post-prep Application

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.

Time frame: Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment

Secondary Outcomes

Change in Skin Flora Relative to 10 Minutes Post-prep Application

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.

Time frame: 10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.