In Vivo Preoperative Skin Preparation Persistence Evaluation

Phase 2

Completed

• Conditions: Bacterial Recovery of Skin Flora Post-product Application
• Interventions: Drug: ChloraPrep; Drug: 3M CHG/IPA Prep

• Registration Number: NCT03155178
• Lead Sponsor: Solventum US LLC

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2016-12-05
• Primary Completion: 2017-04-25
• Study Completion: 2017-04-25
• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-16
• Disposition First Submitted: 2017-08-09
• Disposition First Submitted QC: 2017-08-09
• Disposition First Posted: 2017-08-11
• Results First Submitted: 2019-03-13
• Results First Submitted QC: 2020-02-20
• Results First Posted: 2020-02-28
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ChloraPrep	ChloraPrep	Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes.
3M CHG/IPA Prep	3M CHG/IPA Prep	Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.