In-vivo Efficacy Study of Patient Preoperative Preps

Skin Flora Bacterial Reduction Post-product Application Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01968356
• Other study ID #: EM-012759
• Status: Terminated
• Phase: Phase 3
• Start date: October 2013
• Est. completion date: January 2014

Study information

• Verified date: July 2021
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

Description:

The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%. On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours. On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 171
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• 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

• Skin Flora Bacterial Reduction Post-product Application

Intervention

Drug:
• 3M CHG/IPA Prep Colorless
Apply topically.
• 3M CHG/IPA Prep Tint
Apply topically.
• ChloraPrep
Apply topically.
• Saline
Apply topically.

Locations

Country	Name	City	State
United States	BioScience Laboratories, Inc.	Bozeman	Montana

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder Rate	On the abdominal region a responder was a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours.; On the inguinal region a responder was a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline at 6 hours.	baseline, 10 minute post-product application and 6 hour post-product application
Primary	Skin Flora Baseline for Abdominal and Inguinal Regions	Log10/cm2 baseline skin flora for abdominal and inguinal regions	Baseline
Primary	Skin Flora Recovery Post-treatment	Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions	10 minutes and 6 hours post-treatment
Primary	Reduction of Skin Flora Post-treatment	Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours	Baseline, 10 minutes and 6 hours
Secondary	Safety as Assessed by Skin Irritation Scores	Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.	Baseline
Secondary	Safety as Assessed by Skin Irritation Scores	Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.	10 minutes post-treatment
Secondary	Safety as Assessed by Skin Irritation Scores	Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.	6 hours post-treatment