In Vivo Preoperative Skin Preparation Persistence Evaluation

NCT03155178 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EM-013953
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Bacterial Recovery of Skin Flora Post-product Application

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• 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

Study Arms (2)

3M CHG/IPA Prep

EXPERIMENTAL

Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes.

Drug: 3M CHG/IPA Prep

ChloraPrep

ACTIVE COMPARATOR

Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes.

Drug: ChloraPrep

Interventions

3M CHG/IPA Prep DRUG

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

Also known as: Chlorhexidine Gluconate and Isopropyl Alcohol, CHG/IPA

3M CHG/IPA Prep

ChloraPrep DRUG

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

Also known as: Chlorhexidine Gluconate and Isopropyl Alcohol, Chlorhexidine 2% / Isopropyl alcohol 70%, CHG/IPA, ChloraPrep One-Step

ChloraPrep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of any race
• Subjects in good health
• Minimum skin flora baseline requirements on abdomen and groin

You may not qualify if:

• 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

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

MeSH Terms

Interventions

chlorhexidine gluconate; 2-Propanol; Chlorhexidine; Ethanol

Intervention Hierarchy (Ancestors)

Propanols; Alcohols; Organic Chemicals; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Joan E. Paulson
• Organization: 3M

jepaulson@mmm.com

651-736-6583

Study Officials

• Rozalia Olsavszky, MD

  Evic / Eurofins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 16, 2017
• Study Start: December 5, 2016
• Primary Completion: April 25, 2017
• Study Completion: April 25, 2017
• Last Updated: October 2, 2024
• Results First Posted: February 28, 2020

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share