In Vivo Patient Preoperative Skin Prep Persistence

Phase 2

Completed

• Conditions: Bacterial Recovery of Skin Flora Post-Product Application
• Interventions: Other: Normal Saline - Abdominal Region; Drug: 3M CHG/IPA Surgical Skin Preparation - Abdominal Region; Drug: 3M CHG/IPA Surgical Skin Preparation - Inguinal Region; Other: Normal Saline - Inguinal Region

• Registration Number: NCT02447497
• Lead Sponsor: Solventum US LLC

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.

Detailed Description

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 Timeline

• Study Start: 2015-03
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Study First Submitted: 2015-05-08
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-19
• Disposition First Submitted: 2017-02-08
• Disposition First Submitted QC: 2017-02-08
• Disposition First Posted: 2017-02-09
• Results First Submitted: 2020-10-05
• Results First Submitted QC: 2020-10-30
• Results First Posted: 2020-11-23
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline - Abdominal Region	Normal Saline - Abdominal Region	Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes.
3M CHG/IPA - Abdominal Region	3M CHG/IPA Surgical Skin Preparation - Abdominal Region	Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes.
3M CHG/IPA - Inguinal Region	3M CHG/IPA Surgical Skin Preparation - Inguinal Region	Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes.
Normal Saline - Inguinal Region	Normal Saline - Inguinal Region	Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes.

Primary Outcome Measures

Name	Time	Method
Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline	Baseline, 48 hours and 72 hours 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 two defined post-prep sampling times relative to baseline.

Secondary Outcome Measures

Name	Time	Method
Safety as Assessed by Skin Irritation Scores Coded by Study Staff	48 hours and 72 hours post-product application	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.
Safety as Assessed by Adverse Events	To 72 hours post treatment	Number of subjects with adverse events as self-reported or identified by study staff

Trial Locations

Locations (1)

MicroBioTest; 🇺🇸 Sterling, Virginia, United States