In Vivo Preoperative Skin Preparation Persistence Evaluation

Bacterial Recovery of Skin Flora Post-product Application Clinical Trial

Official title:

96-hour Antimicrobial Persistence Assessment Following Exposure to Saline and Blotting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03155178
• Other study ID #: EM-013953
• Status: Completed
• Phase: Phase 2
• Start date: December 5, 2016
• Est. completion date: April 25, 2017

Study information

• Verified date: February 2020
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Persistent antimicrobial effectiveness was evaluated by measuring the regrowth of normal skin flora at 48 hours, 72 hours and 96 hours, and the suppression of regrowth relative to post-prep (10-min) at 48 hours, 72 hours and 96 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: April 25, 2017
• Est. primary completion date: April 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects of any race

• Subjects in good 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 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

Related Conditions & MeSH terms

• Bacterial Recovery of Skin Flora Post-product Application

Intervention

Drug:
• 3M CHG/IPA Prep
Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.
• ChloraPrep
Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
3M

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment	Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0=no reaction, 1=mild, 2=moderate, 3=severe.	Assessed at baseline (pre-treatment) and 10 minutes post-treatment, 48 hours post-treatment, 72 hours post-treatment, 96 hours post-treatment
Primary	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	Change in Skin Flora Relative to 10 Minutes Post-prep Application	Log10 CFU/cm^2 regrowth of skin flora, relative to 10-minute post-treatment log10 CFU/cm^2, at 3 defined post-treatment sampling times.	10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment