Microbial Colonization
Conditions
Brief summary
This single site study is a randomized, controlled, partially-blinded design enrolling a minimum of 516 healthy volunteers, where each subject will receive two of the planned study products on the product application sites of the abdomen and/or groin.
Detailed description
To demonstrate the antimicrobial activity of the Investigational Product (IP) by comparing counts of resident skin microbes, obtained after IP application to intact skin of the abdomen and groin, to counts obtained prior to application.
Interventions
COMBINATION_PRODUCTInvestigational Product
2%(w/v) Chlorhexidine in 70%(v/v) Isopropyl skin preparation
OTHERReference Standard
60% (v/v) 1-propanol skin preparation
COMBINATION_PRODUCTActive Comparator
ChloraPrep® SEPP® skin preparation
OTHERNegative Control
0.9% Normal Saline skin preparation
Sponsors
Becton, Dickinson and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Study products cannot be blinded to staff member(s) performing product applications, sample collections. Staff member(s) performing bacterial enumeration will be blinded from the identification of all study product assignments.
Intervention model description
Healthy adult volunteers that meet inclusion/exclusion criteria will be randomized to receive 2 of the 4 products on bilateral site on the abdomen and/or groin.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Read, understand, and provide signed informed consent. 2. Are healthy subjects in good general health 3. Are 18 years of age or older 4. If females of childbearing potential, are using an acceptable form of birth control for at least 28 days immediately preceding Day 1 and throughout the duration of the study. Acceptable methods are established, effective hormonal contraception (oral/implant/injectable/transdermal/intra-vaginal), intra-uterine device \[IUD\], diaphragm with spermicide, condom with spermicide, abstinence, bilateral tubal ligation, or are in a monogamous relationship with a partner who has had a vasectomy 5. In the case of females of childbearing potential, have a negative urine pregnancy test (UPT) on Product Application Day prior to any applications of the study products. 6. Are free of any systemic or dermatologic disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs. 7. Have minimal Screening Day bacterial count.
Exclusion criteria
1. Have had exposure to topical or systemic antimicrobials or any other product known to affect the normal microbial flora of the skin, antibiotics or steroids (other than hormones for contraception or post-menopausal reasons) within the product restriction period and for the remainder of the study. Restrictions include, but are not limited to antimicrobial soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, after shaves, and colognes. 2. Subjects who have a history of skin allergies. 3. Have known allergies or sensitivity to vinyl, latex (rubber), alcohols, metals, inks, common consumer/beauty products, tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine, or any other product components. 4. Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools within the product restriction period and for the remainder of the study. 5. Use of tanning beds, hot waxes, or depilatories, including shaving (in the applicable product application areas) within the product restriction period and for the remainder of the study. 6. Have had exposure of the product application sites to strong detergents, acids, bases, bug repellant, fabric softener-treated clothing, UV treated clothing, other household chemicals in the applicable product application areas or other irritants during the product restriction period or during the study period. 7. Have a history of skin cancer within 6 inches of applicable product application areas, or are currently being treated for skin cancer or have received treatment for any type of internal cancer within the 5 years prior to enrollment. 8. Subjects who have a history of asthma, diabetes, hepatitis B or C, an organ transplant, mitral valve prolapse with a heart murmur, congenital heart disease, lupus, Crohn's disease, medicated multiple sclerosis, internal prosthesis or any immunocompromised conditions (such as AIDS or HIV positive). 9. A currently active skin disease or inflammatory skin condition (for example contact dermatitis) anywhere on the body. 10. Any tattoos or scars (including stretch marks) on the product application sites or within 2 inches of the product application sites; skin blemishes or warts may be permissible with the specific approval of the Investigator or consulting physician. 11. Dermatoses, cuts, lesions, active skin rashes, scabs, breaks in the skin or other skin disorders within 6 inches on or around the product application sites. 12. Subjects who have showered or bathed within at least 72 hours of the Product Application Day. Sponge baths may be taken, however, the lower abdomen and upper thigh region must be avoided. 13. Subjects who have an irritation score of 1 or greater (any redness, swelling, rash, or dryness present at any product application area) for any individual skin condition prior to the Product Application Day baseline sample collection. 14. Are females who are pregnant, plan to become pregnant during the study, or are breastfeeding a child. 15. Are unable to adhere to or understand the protocol. 16. Have used an investigational drug or participated in an investigational study within 30 days prior to signing the informed consent for this study or are currently participating in a clinical study. 17. Are employed by or are a family member of staff of BD or the study site conducting the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application | 30 seconds and 6 hours post-product application | Bacterial log10/cm\^2 reductions for abdominal and groin sites post-product application (30 seconds and 6 hours) using the Investigational Product or Reference Standard. |
| Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application. | Baseline and 10 minutes post-product application | Evaluation of antimicrobial activity will be based on log10 CFU/cm2 of resident microbes on skin before and after each product application on the abdomen and groin. |
| Responder Rate at 6 Hours Post-Product Application on the Abdomen. | 6 hours post-product application | Number of participants with bacterial reduction greater than or equal to baseline (0). |
| Responder Rate at 6 Hours Post-Product Application on the Groin. | 6 hours post-product application | Number of participants with bacterial reduction greater than or equal to baseline (0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application. | Baseline and 30 seconds post-product application | Evaluation of antimicrobial activity will be based on log10 CFU/cm2 of resident microbes on skin before and after each product application on the abdomen and groin. |
Countries
Romania
Participant flow
Pre-assignment details
Participants were only treated if screening day baseline bacterial counts met the inclusion criteria. Participants were treated with 2 out of 4 study products (Investigational Product, Reference Standard, Active control and Negative Control) 1 on the left side of the body (both groin and abdomen), 1 on the right side of the body (both groin and abdomen).
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All Participants Who Completed Evaluations | 1,121 |
| Total | 1,121 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 0 Participants |
| Race (NIH/OMB) White | 1120 Participants |
| Region of Enrollment Romania | 1121 participants |
| Sex: Female, Male Female | 205 Participants |
| Sex: Female, Male Male | 916 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 / 609 | 0 / 419 | 0 / 609 | 0 / 605 |
| other Total, other adverse events | 0 / 609 | 0 / 419 | 0 / 609 | 0 / 605 |
| serious Total, serious adverse events | 0 / 609 | 0 / 419 | 0 / 609 | 0 / 605 |
Outcome results
Primary
Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application.
Evaluation of antimicrobial activity will be based on log10 CFU/cm2 of resident microbes on skin before and after each product application on the abdomen and groin.
Time frame: Baseline and 10 minutes post-product application
Population: This outcome includes FDA test requirements for an investigational product (IP) to demonstrate superior antimicrobial activity to a negative control and non-inferiority to an active control at the immediate time point of 10 minutes on the abdomen and groin. This outcome does not require a reference standard. Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 10 minutes post-product application.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Product | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application. | Abdomen Baseline | 3.93 Log10 CFU/cm^2 | Standard Deviation 0.61 |
| Investigational Product | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application. | Abdomen 10 Minutes | 1.34 Log10 CFU/cm^2 | Standard Deviation 1.13 |
| Investigational Product | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application. | Groin Baseline | 6.14 Log10 CFU/cm^2 | Standard Deviation 0.47 |
| Investigational Product | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application. | Groin 10 Minutes | 2.46 Log10 CFU/cm^2 | Standard Deviation 1.36 |
| Reference Standard | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application. | Groin 10 Minutes | 2.70 Log10 CFU/cm^2 | Standard Deviation 1.32 |
| Reference Standard | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application. | Abdomen Baseline | 3.88 Log10 CFU/cm^2 | Standard Deviation 0.58 |
| Reference Standard | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application. | Groin Baseline | 6.16 Log10 CFU/cm^2 | Standard Deviation 0.46 |
| Reference Standard | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application. | Abdomen 10 Minutes | 1.31 Log10 CFU/cm^2 | Standard Deviation 1.04 |
| Negative Control | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application. | Groin 10 Minutes | 4.84 Log10 CFU/cm^2 | Standard Deviation 0.7 |
| Negative Control | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application. | Abdomen 10 Minutes | 3.19 Log10 CFU/cm^2 | Standard Deviation 0.8 |
| Negative Control | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application. | Groin Baseline | 6.17 Log10 CFU/cm^2 | Standard Deviation 0.48 |
| Negative Control | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 10 Minutes Post-product Application. | Abdomen Baseline | 4.00 Log10 CFU/cm^2 | Standard Deviation 0.62 |
Comparison: Abdomen at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the abdomen at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site 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: [-0.15, 0.16]
Comparison: Groin at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the groin at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site 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: [-0.43, -0.05]
Comparison: Abdomen at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the abdomen at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site 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: [1.66, 1.97]
Comparison: Groin at 10 minutes post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the groin at 10 minutes post-product application. ATE was calculated using a linear regression model for each body site 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: [2.19, 2.56]
Primary
Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application
Bacterial log10/cm\^2 reductions for abdominal and groin sites post-product application (30 seconds and 6 hours) using the Investigational Product or Reference Standard.
Time frame: 30 seconds and 6 hours post-product application
Population: This outcome includes test requirements outlined by Health Canada (HC) for an investigational product to demonstrate immediate and persistent antimicrobial activity against a reference standard, 60% v/v 1-Propanol. This outcome does not include negative and active control comparators. 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 6 hours post-product application.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Investigational Product | Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application | Abdomen 30 Seconds | 2.53 Log10 CFU/cm^2 |
| Investigational Product | Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application | Abdomen 6 hours | 2.68 Log10 CFU/cm^2 |
| Investigational Product | Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application | Groin 30 Seconds | 3.69 Log10 CFU/cm^2 |
| Investigational Product | Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application | Groin 6 hours | 3.89 Log10 CFU/cm^2 |
| Reference Standard | Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application | Groin 6 hours | 4.08 Log10 CFU/cm^2 |
| Reference Standard | Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application | Abdomen 30 Seconds | 2.70 Log10 CFU/cm^2 |
| Reference Standard | Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application | Groin 30 Seconds | 4.07 Log10 CFU/cm^2 |
| Reference Standard | Antimicrobial log10 Reductions From Baseline for Investigational Product and Reference Standard at 30 Seconds and 6 Hours Post-product Application | Abdomen 6 hours | 2.73 Log10 CFU/cm^2 |
Primary
Responder Rate at 6 Hours Post-Product Application on the Abdomen.
Number of participants with bacterial reduction greater than or equal to baseline (0).
Time frame: 6 hours post-product application
Population: This outcome includes FDA test requirements to demonstrate persistence of the investigational product (IP) at 6 hours post-product application on the abdomen. This outcome does not require a reference standard. Analysis only includes participants with required treatment day baseline bacterial counts on the abdomen at baseline and non-missing data at 6 hours post-product application.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational Product | Responder Rate at 6 Hours Post-Product Application on the Abdomen. | 286 Participants |
| Reference Standard | Responder Rate at 6 Hours Post-Product Application on the Abdomen. | 305 Participants |
| Negative Control | Responder Rate at 6 Hours Post-Product Application on the Abdomen. | 265 Participants |
Primary
Responder Rate at 6 Hours Post-Product Application on the Groin.
Number of participants with bacterial reduction greater than or equal to baseline (0).
Time frame: 6 hours post-product application
Population: This outcome includes FDA test requirements to demonstrate persistence of the investigational product (IP) at 6 hours post-product application on the groin. This outcome does not require a reference standard. Analysis only includes participants with required treatment day baseline bacterial counts on the groin at baseline and non-missing data at 6 hours post-product application.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational Product | Responder Rate at 6 Hours Post-Product Application on the Groin. | 295 Participants |
| Reference Standard | Responder Rate at 6 Hours Post-Product Application on the Groin. | 293 Participants |
| Negative Control | Responder Rate at 6 Hours Post-Product Application on the Groin. | 291 Participants |
Secondary
Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application.
Evaluation of antimicrobial activity will be based on log10 CFU/cm2 of resident microbes on skin before and after each product application on the abdomen and groin.
Time frame: Baseline and 30 seconds post-product application
Population: This outcome includes FDA test requirements for an investigational product (IP) to demonstrate superior antimicrobial activity to a negative control and non-inferiority to an active control at the immediate time point of 30 seconds on the abdomen and groin. This outcome does not require a reference standard. Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 30 seconds post-product application.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Investigational Product | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application. | Abdomen Baseline | 3.93 Log10 CFU/cm^2 | Standard Deviation 0.61 |
| Investigational Product | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application. | Abdomen 30 seconds | 1.40 Log10 CFU/cm^2 | Standard Deviation 1.19 |
| Investigational Product | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application. | Groin Baseline | 6.14 Log10 CFU/cm^2 | Standard Deviation 0.47 |
| Investigational Product | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application. | Groin 30 seconds | 2.46 Log10 CFU/cm^2 | Standard Deviation 1.36 |
| Reference Standard | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application. | Groin 30 seconds | 2.80 Log10 CFU/cm^2 | Standard Deviation 1.34 |
| Reference Standard | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application. | Abdomen Baseline | 3.88 Log10 CFU/cm^2 | Standard Deviation 0.58 |
| Reference Standard | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application. | Groin Baseline | 6.16 Log10 CFU/cm^2 | Standard Deviation 0.46 |
| Reference Standard | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application. | Abdomen 30 seconds | 1.30 Log10 CFU/cm^2 | Standard Deviation 1.06 |
| Negative Control | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application. | Groin 30 seconds | 5.20 Log10 CFU/cm^2 | Standard Deviation 0.62 |
| Negative Control | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application. | Abdomen 30 seconds | 3.43 Log10 CFU/cm^2 | Standard Deviation 0.72 |
| Negative Control | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application. | Groin Baseline | 6.17 Log10 CFU/cm^2 | Standard Deviation 0.48 |
| Negative Control | Antimicrobial Activity (Efficacy): log10 CFU/cm2 of Resident Microbes on Skin at Baseline and 30 Seconds Post-product Application. | Abdomen Baseline | 4.00 Log10 CFU/cm^2 | Standard Deviation 0.62 |
Comparison: Abdomen at 30 seconds post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Active Control on the abdomen at 30 seconds post-product application. ATE was calculated using a linear regression model for each body site 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: [-0.08, 0.23]
Comparison: Abdomen at 30 seconds post-product application.~Average treatment effect (ATE) of the Investigational Product compared to the Negative Control on the abdomen at 30 seconds post-product application. ATE was calculated using a linear regression model for each body site 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: [1.84, 2.15]