Preoperative Skin Preparation
Conditions
Brief summary
Objective of this study is to compare the antimicrobial properties of an investigational agent to an active control and a negative control when applied to specific body locations. Testing will be performed according to the procedures outlined in the Food and Drug Administration Tentative Final Monograph (TFM) for Effectiveness Testing of a Patient Preoperative Skin Preparation
Interventions
DRUGOCT - clear
Investigational Product #1: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear
DRUGOCT- tinted
Investigational product #2: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted
OTHERChloraPrep
Active Control: ChloraPrep® - Hi-Lite Orange® applicator
OTHERSaline
Negative Control: sterile 0.9% saline applied with single use applicator
Sponsors
Becton, Dickinson and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects may be of either sex, at least 18 years of age and of any race. * Subjects must be in good general health. * Subjects must read and sign an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and the List of Restricted Products prior to participating in the study. * Female subjects must complete a urine pregnancy test and have negative results documented before proceeding to treatment with test materials. * All subjects must meet Screening Day microbial baseline requirements established by the sponsor.
Exclusion criteria
* Known allergies or sensitivities to sunscreens, deodorants, laundry detergents, fragrances, vinyl, latex (rubber), alcohols, soaps, metals, inks, dyes, tape adhesives, or to common antibacterial agents found in soaps, lotions, ointments, or particularly the active ingredients of the study product drug solutions. * Exposure of test sites to strong detergents, solvents, or other irritants within the 14-day product-restriction period or during the test period. * Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 14-day product-restriction period or during the test period. * Wear fabric softener-, bug repellent-, or UV-treated clothing during the 14-day product-restriction period or during the test period. * Use of systemic or topical antibiotic medications, steroid medications (other than for hormonal contraception or post-menopausal reasons), or any other product known to affect the normal microbial flora of the skin during the 14-day product-restriction period or during the test period. * A medical diagnosis of a physical condition, such as a current or recent severe illness, mitral valve prolapse with a heart murmur, congenital heart disease, hepatitis B, hepatitis C, an organ transplant, ports, or an immunocompromised condition such as AIDS (or HIV positive), lupus, medicated diabetes (Type 1 or 2), ulcerative colitis, Crohn's disease, asthma requiring daily medication, fibromyalgia or multiple sclerosis (medicated). * Any tattoos or scars within 2 inches of the test sites; skin blemishes or warts may be permissible with the specific approval of the Principal Investigator or consulting physician. * Dermatoses, cuts, lesions, active skin rashes, scabs, breaks in the skin or other skin disorders within 6 inches, on, or around the test sites. * A currently active skin disease or inflammatory skin condition (for example, contact dermatitis, psoriasis, eczema) anywhere on the body that, in the opinion of the Principal Investigator, would compromise subject safety or study integrity. * Subjects who receive an irritation score of 1 (any redness, swelling, rash, or dryness present in any treatment area) for any individual skin condition prior to the Screening Day baseline or Treatment Day baseline sample collection. * Participation in another clinical study in the past 30 days or current participation in another clinical study at time of signing informed consent. * Showering, bathing, or swimming within the 72 hour period prior to sampling for baseline screening, the test day, or throughout the test period. * Pregnancy, plans to become pregnant or impregnate a sexual partner within the pre-test and test periods of the study, or nursing a child. All female subjects will be required to complete a urine pregnancy test on the day of test material application, prior to treatment. Both gender of subjects must be willing to use an acceptable method of contraception to prevent pregnancy for at least 14 days immediately preceding Treatment Day and throughout the duration of the study. * Any medical condition or use of any medications that, in the opinion of the Principal Investigator or Consulting Physician, would preclude participation. * Unwillingness to fulfill the performance requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antimicrobial Activity of the Investigational Products Compared to Control. | 10 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate at 6 Hours Post-application | 6 hours | Number of participants with bacterial reduction greater than or equal to baseline (0) |
Countries
United States
Participant flow
Pre-assignment details
Number of participants enrolled is 131. Each participant has up to 4 sites on their body treated with assigned products. Participants are treated bilaterally on the abdomen and/or groin based on passing screening criteria.
Participants by arm
| Arm | Count |
|---|---|
| Treated Subjects All treated subjects | 131 |
| Total | 131 |
Baseline characteristics
| Characteristic | Treated Subjects |
|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 119 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 119 Participants |
| Region of Enrollment United States | 131 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 81 Participants |
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 / 65 | 0 / 66 | 0 / 66 | 0 / 65 |
| other Total, other adverse events | 0 / 65 | 0 / 66 | 0 / 66 | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 | 0 / 66 | 0 / 66 | 0 / 65 |
Outcome results
Primary
Antimicrobial Activity of the Investigational Products Compared to Control.
Time frame: 10 minutes
Population: Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 30 seconds and 10 minutes.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Product #1 | Antimicrobial Activity of the Investigational Products Compared to Control. | Abdomen 30 seconds | 0.98 log10 CFU/cm^2 | Standard Deviation 1.31 |
| Investigational Product #1 | Antimicrobial Activity of the Investigational Products Compared to Control. | Groin 30 seconds | 2.91 log10 CFU/cm^2 | Standard Deviation 1.26 |
| Investigational Product #1 | Antimicrobial Activity of the Investigational Products Compared to Control. | Abdomen Baseline | 3.85 log10 CFU/cm^2 | Standard Deviation 0.51 |
| Investigational Product #1 | Antimicrobial Activity of the Investigational Products Compared to Control. | Groin Baseline Groin Baseline | 6.03 log10 CFU/cm^2 | Standard Deviation 0.52 |
| Investigational Product #1 | Antimicrobial Activity of the Investigational Products Compared to Control. | Abdomen 10 minutes | 1.20 log10 CFU/cm^2 | Standard Deviation 1.3 |
| Investigational Product #1 | Antimicrobial Activity of the Investigational Products Compared to Control. | Groin 10 minutes | 2.37 log10 CFU/cm^2 | Standard Deviation 1.34 |
| Investigational Product #2 | Antimicrobial Activity of the Investigational Products Compared to Control. | Abdomen 10 minutes | 0.91 log10 CFU/cm^2 | Standard Deviation 1.15 |
| Investigational Product #2 | Antimicrobial Activity of the Investigational Products Compared to Control. | Groin Baseline Groin Baseline | 6.05 log10 CFU/cm^2 | Standard Deviation 0.59 |
| Investigational Product #2 | Antimicrobial Activity of the Investigational Products Compared to Control. | Groin 10 minutes | 2.66 log10 CFU/cm^2 | Standard Deviation 1.37 |
| Investigational Product #2 | Antimicrobial Activity of the Investigational Products Compared to Control. | Abdomen 30 seconds | 1.05 log10 CFU/cm^2 | Standard Deviation 1.23 |
| Investigational Product #2 | Antimicrobial Activity of the Investigational Products Compared to Control. | Groin 30 seconds | 3.03 log10 CFU/cm^2 | Standard Deviation 1.16 |
| Investigational Product #2 | Antimicrobial Activity of the Investigational Products Compared to Control. | Abdomen Baseline | 3.91 log10 CFU/cm^2 | Standard Deviation 0.52 |
| Active Control | Antimicrobial Activity of the Investigational Products Compared to Control. | Abdomen 10 minutes | 1.08 log10 CFU/cm^2 | Standard Deviation 1.1 |
| Active Control | Antimicrobial Activity of the Investigational Products Compared to Control. | Abdomen Baseline | 3.87 log10 CFU/cm^2 | Standard Deviation 0.55 |
| Active Control | Antimicrobial Activity of the Investigational Products Compared to Control. | Abdomen 30 seconds | 1.34 log10 CFU/cm^2 | Standard Deviation 1.24 |
| Active Control | Antimicrobial Activity of the Investigational Products Compared to Control. | Groin 10 minutes | 2.66 log10 CFU/cm^2 | Standard Deviation 1.42 |
| Active Control | Antimicrobial Activity of the Investigational Products Compared to Control. | Groin Baseline Groin Baseline | 6.03 log10 CFU/cm^2 | Standard Deviation 0.53 |
| Active Control | Antimicrobial Activity of the Investigational Products Compared to Control. | Groin 30 seconds | 3.05 log10 CFU/cm^2 | Standard Deviation 1.19 |
| Negative Control | Antimicrobial Activity of the Investigational Products Compared to Control. | Abdomen 10 minutes | 3.12 log10 CFU/cm^2 | Standard Deviation 0.87 |
| Negative Control | Antimicrobial Activity of the Investigational Products Compared to Control. | Abdomen 30 seconds | 3.42 log10 CFU/cm^2 | Standard Deviation 0.72 |
| Negative Control | Antimicrobial Activity of the Investigational Products Compared to Control. | Groin 10 minutes | 4.91 log10 CFU/cm^2 | Standard Deviation 0.43 |
| Negative Control | Antimicrobial Activity of the Investigational Products Compared to Control. | Groin 30 seconds | 5.11 log10 CFU/cm^2 | Standard Deviation 0.41 |
| Negative Control | Antimicrobial Activity of the Investigational Products Compared to Control. | Abdomen Baseline | 3.84 log10 CFU/cm^2 | Standard Deviation 0.55 |
| Negative Control | Antimicrobial Activity of the Investigational Products Compared to Control. | Groin Baseline Groin Baseline | 5.93 log10 CFU/cm^2 | Standard Deviation 0.5 |
Comparison: Abdomen 10 minutes~Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [-0.44, 0.69]
Comparison: Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [1.36, 2.49]
Comparison: Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [-0.73, 0.36]
Comparison: Abdomen 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [1.69, 2.78]
Comparison: Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [-0.9, 0.31]
Comparison: Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [1.98, 3.22]
Comparison: Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [-0.61, 0.57]
Comparison: Groin 10 minutes Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [1.72, 2.93]
Comparison: Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [-0.91, 0.22]
Comparison: Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [1.88, 3.01]
Comparison: Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [-0.85, 0.24]
Comparison: Abdomen 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [1.87, 2.95]
Comparison: Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [-0.67, 0.4]
Comparison: Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [1.7, 2.8]
Comparison: Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [-0.56, 0.48]
Comparison: Groin 30 seconds Average treatment effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 bacterial counts as a covariate.95% CI: [1.62, 2.68]
Secondary
Responder Rate at 6 Hours Post-application
Number of participants with bacterial reduction greater than or equal to baseline (0)
Time frame: 6 hours
Population: Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 6 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Investigational Product #1 | Responder Rate at 6 Hours Post-application | Abdomen | 37 Participants |
| Investigational Product #1 | Responder Rate at 6 Hours Post-application | Inguen | 42 Participants |
| Investigational Product #2 | Responder Rate at 6 Hours Post-application | Inguen | 48 Participants |
| Investigational Product #2 | Responder Rate at 6 Hours Post-application | Abdomen | 43 Participants |
| Active Control | Responder Rate at 6 Hours Post-application | Abdomen | 47 Participants |
| Active Control | Responder Rate at 6 Hours Post-application | Inguen | 44 Participants |
| Negative Control | Responder Rate at 6 Hours Post-application | Abdomen | 42 Participants |
| Negative Control | Responder Rate at 6 Hours Post-application | Inguen | 40 Participants |