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Trial Outcomes & Findings for In Vivo Preoperative Skin Preparation Efficacy Study Within a Defined Product Coverage Area (NCT NCT03681990)

NCT ID: NCT03681990

Last Updated: 2024-10-02

Results Overview

The primary measure of efficacy is change in skin flora log10 CFU/cm\^2 in each of the skin sampling sites relative to baseline skin flora log10 CFU/cm\^2. Baseline samples must satisfy the greater than or equal to 3.0 in each of the sampling sites, to be used for data analysis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

Post-treatment sampling randomized as 10-minute or 13-minute post-product application

Results posted on

2024-10-02

Participant Flow

Unit of analysis: test sites on skin

Participant milestones

Participant milestones
Measure
3M CHG/IPA Prep
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; samples collected from center, mid-periphery, and periphery of test site on skin in application area.
Overall Study
STARTED
28 84
Overall Study
COMPLETED
28 84
Overall Study
NOT COMPLETED
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

In Vivo Preoperative Skin Preparation Efficacy Study Within a Defined Product Coverage Area

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
3M CHG/IPA Prep / Center
n=28 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from center test site on skin in application area.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
24 Participants
n=5 Participants
Age, Categorical
>=65 years
4 Participants
n=5 Participants
Sex/Gender, Customized
Female
0 participants
n=5 Participants
Sex/Gender, Customized
Male
28 participants
n=5 Participants
Race/Ethnicity, Customized
Ethnicity - Hispanic or Latino
0 participants
n=5 Participants
Race/Ethnicity, Customized
Ethnicity - Not Hispanic or Latino
28 participants
n=5 Participants
Race/Ethnicity, Customized
Race - American Indian or Alaska Native
0 participants
n=5 Participants
Race/Ethnicity, Customized
Race - Asian
0 participants
n=5 Participants
Race/Ethnicity, Customized
Race - Native Hawaiian or Other Pacific Islander
0 participants
n=5 Participants
Race/Ethnicity, Customized
Race - Black or African American
0 participants
n=5 Participants
Race/Ethnicity, Customized
Race - White
28 participants
n=5 Participants
Race/Ethnicity, Customized
Race - More than one race
0 participants
n=5 Participants
Race/Ethnicity, Customized
Race - Unknown or not reported
0 participants
n=5 Participants
Evaluable Treatment Day Baseline Count
Evaluable Subjects
20 Participants
n=5 Participants
Evaluable Treatment Day Baseline Count
Non-evaluable Subjects
8 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Post-treatment sampling randomized as 10-minute or 13-minute post-product application

Population: The primary analysis data set used a Modified Intent to Treat population: Subjects were excluded who did not meet the baseline requirement of greater than or equal to 3.0 log10 CFU/cm2 in all three sampling sites on the treatment site. The sampling time for efficacy evaluation was 10 minutes or 13 minutes post-product application as per the randomization schedule.

The primary measure of efficacy is change in skin flora log10 CFU/cm\^2 in each of the skin sampling sites relative to baseline skin flora log10 CFU/cm\^2. Baseline samples must satisfy the greater than or equal to 3.0 in each of the sampling sites, to be used for data analysis.

Outcome measures

Outcome measures
Measure
3M CHG/IPA Prep / Center
n=20 test sites on skin
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from center test site on skin in application area.
3M CHG /IPA Prep - Mid-peripheral
n=20 test sites on skin
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from mid-peripheral test site on skin in application area.
3M CHG/IPA Prep - Peripheral
n=20 test sites on skin
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from peripheral test site on skin in application area.
Comparison of Log Change of Skin Flora Relative to Pre-treatment (Baseline) in Each of 3 Sampling Sites at a Defined Post-treatment Sampling Time.
-2.19 log10 CFU/cm^2
Standard Deviation 1.31
-1.85 log10 CFU/cm^2
Standard Deviation 1.57
-2.42 log10 CFU/cm^2
Standard Deviation 1.20

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed pre-treatment (baseline) and post-treatment (10 or 13 minutes)

Population: All treated subjects were considered evaluable for safety. Safety assessments were based on evaluations for skin reactions at the test sites.

Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0 = no reaction, 1 = mild reaction, 2 = moderate reaction, 3 = severe reaction.

Outcome measures

Outcome measures
Measure
3M CHG/IPA Prep / Center
n=28 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from center test site on skin in application area.
3M CHG /IPA Prep - Mid-peripheral
n=28 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from mid-peripheral test site on skin in application area.
3M CHG/IPA Prep - Peripheral
n=28 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from peripheral test site on skin in application area.
Safety Outcome Evaluated by Skin Irritation Assessment
Erythema - pre-treatment rating = 0
28 participants
28 participants
28 participants
Safety Outcome Evaluated by Skin Irritation Assessment
Erythema - post-treatment rating = 0
28 participants
28 participants
28 participants
Safety Outcome Evaluated by Skin Irritation Assessment
Rash - pre-treatment rating = 0
28 participants
28 participants
28 participants
Safety Outcome Evaluated by Skin Irritation Assessment
Dryness - pre-treatment rating = 0
28 participants
28 participants
28 participants
Safety Outcome Evaluated by Skin Irritation Assessment
Rash - post-treatment rating = 0
28 participants
28 participants
28 participants
Safety Outcome Evaluated by Skin Irritation Assessment
Dryness - post-treatment rating = 0
28 participants
28 participants
28 participants
Safety Outcome Evaluated by Skin Irritation Assessment
Edema - pre-treatment rating = 0
28 participants
28 participants
28 participants
Safety Outcome Evaluated by Skin Irritation Assessment
Edema - post-treatment rating = 0
28 participants
28 participants
28 participants

Adverse Events

3M CHG/IPA Prep / Center

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

3M CHG/IPA Mid-peripheral

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

3M CHG/IPA Peripheral

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joan E. Paulson

3M

Phone: 651-736-6583

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place