Bacterial Recovery of Skin Flora Post-Product Application
Conditions
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.
Interventions
DRUG3M CHG/IPA Surgical Skin Preparation - Abdominal Region
Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
OTHERNormal Saline - Abdominal Region
0.9% sodium chloride applied with foam applicator
DRUG3M CHG/IPA Surgical Skin Preparation - Inguinal Region
Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
OTHERNormal Saline - Inguinal Region
0.9% sodium chloride applied with foam applicator
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Pre-assignment details
This is a randomized, paired-comparisons design where each subject will receive two of the planned treatments, one on the left side of body and one on the right. Each subject provided two abdomen test sites, left or right, and/or two inguinal test sites, left or right. A total of 25 subjects were randomized to the abdomen region and 23 subjects were randomized to the inguinal region resulting in 27 subjects providing 96 application test sites on two anatomical regions.
Participants by arm
| Arm | Count |
|---|---|
| 3M CHG/IPA - Abdominal Region - Left or Right Experimental CHG/IPA Prep was randomly assigned to the left or right side of the abdominal test site | 25 |
| 3M CHG/IPA - Abdominal Region - Left or Right Experimental CHG/IPA Prep was randomly assigned to the left or right side of the abdominal test site | 25 |
| Normal Saline - Abdominal Region - Left or Right Saline control was randomly assigned to the left or right side of the abdominal test site | 25 |
| Normal Saline - Abdominal Region - Left or Right Saline control was randomly assigned to the left or right side of the abdominal test site | 25 |
| 3M CHG/IPA Prep - Inguinal Region - Left or Right Experimental CHG/IPA Prep was randomly assigned to the left or right side of the inguinal test site | 23 |
| 3M CHG/IPA Prep - Inguinal Region - Left or Right Experimental CHG/IPA Prep was randomly assigned to the left or right side of the inguinal test site | 23 |
| Normal Saline - Inguinal Region - Left or Right Saline control was randomly assigned to the left or right side of the inguinal test site | 23 |
| Normal Saline - Inguinal Region - Left or Right Saline control was randomly assigned to the left or right side of the inguinal test site | 23 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Did not meet treatment day baseline. | 6 | 5 | 2 | 2 |
| Overall Study | Dressing was compromised | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | 3M CHG/IPA - Abdominal Region - Left or Right | Normal Saline - Abdominal Region - Left or Right | 3M CHG/IPA Prep - Inguinal Region - Left or Right | Normal Saline - Inguinal Region - Left or Right |
|---|---|---|---|---|---|
| Age, Customized >=66 years | 12 Test sites on skin | 3 Test sites on skin | 3 Test sites on skin | 3 Test sites on skin | 3 Test sites on skin |
| Age, Customized Between 18 and 65 years | 84 Test sites on skin | 22 Test sites on skin | 22 Test sites on skin | 20 Test sites on skin | 20 Test sites on skin |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Test sites on skin | 0 Test sites on skin | 0 Test sites on skin | 0 Test sites on skin | 0 Test sites on skin |
| Race/Ethnicity, Customized Asian | 46 Test sites on skin | 12 Test sites on skin | 12 Test sites on skin | 11 Test sites on skin | 11 Test sites on skin |
| Race/Ethnicity, Customized Black or African American | 14 Test sites on skin | 3 Test sites on skin | 3 Test sites on skin | 4 Test sites on skin | 4 Test sites on skin |
| Race/Ethnicity, Customized More than one race | 0 Test sites on skin | 0 Test sites on skin | 0 Test sites on skin | 0 Test sites on skin | 0 Test sites on skin |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Test sites on skin | 0 Test sites on skin | 0 Test sites on skin | 0 Test sites on skin | 0 Test sites on skin |
| Race/Ethnicity, Customized Unknown or not reported | 0 Test sites on skin | 0 Test sites on skin | 0 Test sites on skin | 0 Test sites on skin | 0 Test sites on skin |
| Race/Ethnicity, Customized White | 36 Test sites on skin | 10 Test sites on skin | 10 Test sites on skin | 8 Test sites on skin | 8 Test sites on skin |
| Region of Enrollment United States | 27 participants | 25 participants | 25 participants | 23 participants | 23 participants |
| Sex/Gender, Customized Female | 16 Test sites on skin | 5 Test sites on skin | 5 Test sites on skin | 3 Test sites on skin | 3 Test sites on skin |
| Sex/Gender, Customized Male | 80 Test sites on skin | 20 Test sites on skin | 20 Test sites on skin | 20 Test sites on skin | 20 Test sites on skin |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 23 | 0 / 23 |
Outcome results
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.
Time frame: Baseline, 48 hours and 72 hours post-prep application
Population: Number analyzed includes subjects who met baseline requirements
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Saline - Abdominal Region | Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline | 48-hour timepoint | 0.91 Log10 CFU/cm^2 | Standard Deviation 0.78 |
| Normal Saline - Abdominal Region | Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline | 72-hour timepoint | 0.93 Log10 CFU/cm^2 | Standard Deviation 1.07 |
| 3M CHG/IPA Prep - Abdominal Region | Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline | 72-hour timepoint | 2.44 Log10 CFU/cm^2 | Standard Deviation 1.34 |
| 3M CHG/IPA Prep - Abdominal Region | Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline | 48-hour timepoint | 2.81 Log10 CFU/cm^2 | Standard Deviation 0.97 |
| Normal Saline - Inguinal Region | Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline | 48-hour timepoint | 0.59 Log10 CFU/cm^2 | Standard Deviation 0.79 |
| Normal Saline - Inguinal Region | Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline | 72-hour timepoint | 0.51 Log10 CFU/cm^2 | Standard Deviation 0.73 |
| 3M CHG/IPA Prep - Inguinal Region | Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline | 48-hour timepoint | 2.96 Log10 CFU/cm^2 | Standard Deviation 1.07 |
| 3M CHG/IPA Prep - Inguinal Region | Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline | 72-hour timepoint | 2.91 Log10 CFU/cm^2 | Standard Deviation 1.6 |
Comparison: 48 hours post treatment time point. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFU/cm\^2 on the abdomen. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.p-value: <0.000195% CI: [0.51, 4.1]Paired t-test
Comparison: 48 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFU/cm\^2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.p-value: 0.000195% CI: [0.6, 5.75]Paired t-test
Comparison: 72 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFUcm2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.p-value: 0.000195% CI: [0.17, 3.75]Paired t-test
Comparison: 72 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFUcm2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm\^2 recovery between arms.p-value: 0.000195% CI: [0.13, 5.04]Paired t-test
Secondary
Safety as Assessed by Adverse Events
Number of subjects with adverse events as self-reported or identified by study staff
Time frame: To 72 hours post treatment
Population: Adverse event reports through the treatment period, that is both 48 and 72 hours post dose.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Normal Saline - Abdominal Region | Safety as Assessed by Adverse Events | 0 Participants |
| 3M CHG/IPA Prep - Abdominal Region | Safety as Assessed by Adverse Events | 0 Participants |
| Normal Saline - Inguinal Region | Safety as Assessed by Adverse Events | 0 Participants |
| 3M CHG/IPA Prep - Inguinal Region | Safety as Assessed by Adverse Events | 0 Participants |
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.
Time frame: 48 hours and 72 hours post-product application
Population: Data from the 48-hour and 72-hour timepoints were combined for each skin condition category of erythema, edema, rash and erythema since all ratings for all subjects at all timepoints were scored as zero (no reaction) for all subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Normal Saline - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Erythema: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| Normal Saline - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Erythema: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| Normal Saline - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Edema: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| Normal Saline - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Edema: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| Normal Saline - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Rash: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| Normal Saline - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Rash: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| Normal Saline - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Dryness: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| Normal Saline - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Dryness: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Rash: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Rash: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Erythema: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Dryness: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Dryness: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Edema: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Edema: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Abdominal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Erythema: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| Normal Saline - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Dryness: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| Normal Saline - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Edema: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| Normal Saline - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Edema: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| Normal Saline - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Rash: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| Normal Saline - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Rash: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| Normal Saline - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Dryness: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| Normal Saline - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Erythema: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| Normal Saline - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Erythema: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Edema: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Edema: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Erythema: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Erythema: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Rash: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Dryness: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Dryness: 48-hour timepoint | 0 Score on a scale | Standard Deviation 0 |
| 3M CHG/IPA Prep - Inguinal Region | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | Rash: 72-hour timepoint | 0 Score on a scale | Standard Deviation 0 |