In Vivo Patient Preoperative Skin Prep Persistence

NCT02447497 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EM-05-013509
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacterial Recovery of Skin Flora Post-Product Application

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 48 hours and 72 hours post-prep application

Secondary Outcomes (2)

• Safety as Assessed by Skin Irritation Scores Coded by Study Staff

  48 hours and 72 hours post-product application

• Safety as Assessed by Adverse Events

  To 72 hours post treatment

Study Arms (4)

3M CHG/IPA - Abdominal Region

EXPERIMENTAL

Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes.

Drug: 3M CHG/IPA Surgical Skin Preparation - Abdominal Region

Normal Saline - Abdominal Region

PLACEBO COMPARATOR

Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes.

Other: Normal Saline - Abdominal Region

3M CHG/IPA - Inguinal Region

EXPERIMENTAL

Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes.

Drug: 3M CHG/IPA Surgical Skin Preparation - Inguinal Region

Normal Saline - Inguinal Region

PLACEBO COMPARATOR

Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes.

Other: Normal Saline - Inguinal Region

Interventions

3M CHG/IPA Surgical Skin Preparation - Abdominal Region DRUG

Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

Also known as: SoluPrep

3M CHG/IPA - Abdominal Region

Normal Saline - Abdominal Region OTHER

0.9% sodium chloride applied with foam applicator

Normal Saline - Abdominal Region

3M CHG/IPA Surgical Skin Preparation - Inguinal Region DRUG

Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

Also known as: SoluPrep

3M CHG/IPA - Inguinal Region

Normal Saline - Inguinal Region OTHER

0.9% sodium chloride applied with foam applicator

Normal Saline - Inguinal Region

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 general 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 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

Sponsors & Collaborators

• Solventum US LLC: lead
• 3M: collaborator

Study Sites (1)

MicroBioTest

Sterling, Virginia, 20164, United States

Location

Results Point of Contact

• Title: Nancy Klinger
• Organization: 3M

nmklinger@mmm.com

651 491 9433

Study Officials

• Muhammad H Bashir, MD, CCRP

  MicroBioTest Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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 8, 2015
• First Posted: May 19, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 2, 2024
• Results First Posted: November 23, 2020

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)