In Vivo Patient Preoperative Skin Prep Persistence

Bacterial Recovery of Skin Flora Post-Product Application Clinical Trial

Official title:

Assessment of Antimicrobial Persistence of 3M CHG/IPA Preoperative Skin Preparation Against Resident Flora on the Abdominal and Inguinal Regions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447497
• Other study ID #: EM-05-013509
• Status: Completed
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: April 2015

Study information

• Verified date: June 2023
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Recovery of Skin Flora Post-Product Application

Intervention

Drug:
• 3M CHG/IPA Surgical Skin Preparation - Abdominal Region
Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

Other:
• Normal Saline - Abdominal Region
0.9% sodium chloride applied with foam applicator

Drug:
• 3M CHG/IPA Surgical Skin Preparation - Inguinal Region
Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

Other:
• Normal Saline - Inguinal Region
0.9% sodium chloride applied with foam applicator

Locations

Country	Name	City	State
United States	MicroBioTest	Sterling	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

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